Fatty Liver in Obesity: Long-lifestyle Follow-up (FLiO) (FLiO)

June 7, 2017 updated by: Marian Zulet, Clinica Universidad de Navarra, Universidad de Navarra

Non-alcoholic Fatty Liver Disease (NAFLD) in Overweight and Obese People Under Nutritional and Lifestyle Follow-up: a Randomized Controlled Trial

Non-alcoholic fatty liver disease (NAFLD) is a condition of excessive hepatic lipid accumulation in subjects that consume less than 20g ethanol per day, without other known causes as drugs consumption or toxins exposure. In Western countries, the rate of this disease lies about 30% in the general adult population. The process of developing NAFLD can start from simple steatosis to non-alcoholic steatohepatitis (NASH), which eventually can lead to cirrhosis and hepatocellular carcinoma in the absence of alcohol abuse. Liver biopsy is considered the "gold standard" of steatosis, fibrosis and cirrhosis. However, it is rarely performed because it is an invasive procedure and investigators are focusing in the application of non-invasive liver damage scores for diagnosis.

The pathogenesis of NAFLD is multifactorial and triggered by environmental factors such as unbalanced diets and overnutrition as well as by lack of physical activity in the context of a genetic predisposition. Nowadays, the treatment of NAFLD is based on diet and lifestyle modifications. Weight loss, exercise and healthy eating habits are the main tools to fight NAFLD. Nevertheless, there is no a well characterized dietary pattern and further studies are necessary.

With this background, the general aim of this project is to increase the knowledge on the influence of nutritional/lifestyle interventions in obese patients with NAFLD, as well as contribute to identify non-invasive biomarkers/scores to early diagnosis of this pathology in future obese people.

Study Overview

Detailed Description

This project is framed within the promotion of health and lifestyles and, specifically, in liver disorder linked to obesity (FLiO: Fatty Liver in Obesity).

The investigation addresses a randomized, parallel, long-term personalized nutritional intervention with two strategies: 1) Control diet based on American Heart Association (AHA); 2) Fatty Liver in Obesity (FLiO) diet based on previous results (RESMENA project).The diet is based on macronutrient distribution, quality and quantity, and is characterized by a low glycemic load, high adherence to the Mediterranean diet and a high antioxidant capacity, with the inclusion of anti-inflammatory foods. It also takes into account the distribution of food throughout the day, number of meals, portion sizes, timing of meal, individual needs, dietary behavior (behavioral therapy: eat slowly, teach what to buy, what to eat, when to eat). The participants are instructed to follow this strategy. This strategy (RESMENA) was even more effective than AHA after 6 months follow-up, in terms of significant reduction of abdominal fat and blood glucose level. In addition, this diet had beneficial effects for participants who were obese and had values of altered glucose, reducing significantly in RESMENA participants LDL-oxidized marker. These results are very important to apply in the present investigation since that patients with NAFLD are commonly insulin resistant.

Both strategies were designed within a hypocaloric dietary pattern (-30%) in order to achieve the American Association for the Study of Liver Diseases (AASLD) recommendations for the management of non-alcoholic liver disease (loss of at least 3-5% of body weight appears necessary to improve steatosis, but a greater weight loss, up to 10%, may be needed to improve necroinflammation). At this time the participants are individually supervised and encouraged to follow with the dietary planning instructions assigned. Furthermore, at baseline, 6, 12 and 24 months anticipated variables are obtained. Both dietary groups receive routine control (weight, body composition, strategy adherence) and dietary advice daily by phone (if they need help) and face to face at the time of routine control.

In order to get a integral lifestyle intervention, all participants will be encouraged to follow a healthy lifestyle. Thus, physical activity will be recorded in each dietary group.

The specific tasks:

  1. To recruit and select patients with the adequate characteristics to validate the conclusions reached.
  2. To develop and adequately transmit to each patient a personalized strategy according to the group randomly assigned ( AASLD vs FLiO strategy).
  3. To check the degree of adherence to the strategy set by regular monitoring: semiquantitative questionnaires of food consumption frequency, pedometers, accelerometers, weight control, satiety.
  4. To assess the effect of each strategy on body composition (weight, waist circumference, body fat, muscle mass, bone mineral density), physical status, general biochemistry (lipid profile, glycaemic profile, albumin, blood count, transaminases), specific biomarkers/metabolites in blood or urine (inflammation, oxidative stress, liver damage, appetite, psychological status), quality of life and related factors (anxiety, depression and sleep).
  5. To check the evolution of the liver damage, using non-invasive techniques (ultrasound, elastography and magnetic resonance imaging (MRI), metabolomics analysis) and calculating different validated liver scores from the data obtained with each strategy.
  6. To compare the effectiveness of strategies, considering not only the ability to decrease body fat, but also other risk factors present in the NAFLD patient such as insulin resistance and cardiovascular risk, which will result in improvement of liver damage.
  7. To analyze SNPs (DNA from oral epithelial cells) and the association with NAFLD (diagnosis and response to the strategies).
  8. To study gene expression (mRNAs) and microRNAs in white blood cells for identifying biomarkers of diagnosis and response to dietary strategy.
  9. To analyze gene DNA methylation patterns in white blood cells for identifying biomarkers of diagnosis and response to dietary strategy.
  10. To describe the intestinal microbiota composition by 16s sequencing at baseline and after nutritional intervention for diagnosis and response.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: M. Angeles Zulet, PhD
  • Phone Number: 806317 +34948425600
  • Email: mazulet@unav.es

Study Contact Backup

  • Name: Itziar Abete, PhD
  • Phone Number: 806357 +34948425600
  • Email: iabetego@unav.es

Study Locations

    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Centre for Nutrition Research, University of Navarra
        • Contact:
          • M. Angeles Zulet, PhD
          • Phone Number: 806317 +34948425600
          • Email: mazulet@unav.es
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight or obese
  • Diagnosis of NAFLD
  • Age: 30-80 years
  • Female / Male

Exclusion Criteria:

  • Known liver disease (other than NAFLD)
  • Abuse of alcohol (>21 and >14 units of alcohol a week for men and women, respectively, eg 1 unit = 125 mL of wine);
  • Drug treatments: immunosuppressants, cytotoxic agents, systemic corticosteroids, agents potentially causing fatty liver disease or abnormal liver tests or weight modifiers
  • Active cancer or a history of malignancy in the last 5 years
  • Problems of massive edemas
  • Obesity known endocrine origin (except treated hypothyroidism)
  • Surgical procedure for weight loss
  • ≥ 3kg weight loss in the last 3 months
  • Severe psychiatric disorders
  • Lack of autonomy or inability to follow the diet (including food allergies or intolerances) or/and lifestyle recommendations as well as to follow scheduled visits.
  • Consumption of any type of food supplements (antioxidants, prebiotics, probiotics, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control diet
A conventional and balanced diet based on American Heart Association (AHA) guidelines and lifestyle advice to achieve the objective of American Association for the Study of Liver Diseases (AASLD): loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation.
The participants follow a conventional and balanced distribution of macronutrients (30% fat, 15% protein, 55% carbohydrates), adequate fiber (25-30 g/day) and dietary cholesterol (<250 mg/day) intake according to AHA guidelines. This strategy was included within a personalized energy-restricted diet (-30% individual needs) under healthy lifestyle advice in order to achieve the objectives of AASLD (loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation).
Other Names:
  • American Heart Association diet
Experimental: FLiO diet
A mediterranean dietary strategy based on macronutrient distribution (quantity and quality), antioxidant capacity, meal frequency, dietary behaviour and lifestyle advice to achieve the objective of AASLD: loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation.
The participants follow a strategy based on a distribution of macronutrients 30-35% lipid (extra virgin olive oil and fatty acids Ω3 in detriment of saturated, trans and cholesterol)/ protein 25% (vegetable against animal)/carbohydrates 40-45% (low glycaemic index, fiber 30-35 g/day); high adherence to the Mediterranean diet and natural antioxidants; meal frequency of 7 meals/day; size/composition of the ration suitable for each moment; including traditional foods with no additional economic cost that will allow diet adherence without abandonment; avoid inappropriate mealtimes and the eating manners as the eating rate. The participants are instructed to follow this strategy within a personalized energy-restricted diet (-30%) and under healthy lifestyle advice to achieve AASLD objectives.
Other Names:
  • Fatty Liver in Obesity diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Weight at 6 months
Time Frame: Baseline and 6 months
Weight will be measured by a digital scale
Baseline and 6 months
Change from 6 month Weight at 12 months
Time Frame: 6 months and 12 months
Weight will be measured by a digital scale
6 months and 12 months
Change from Baseline Weight at 12 months
Time Frame: Baseline and 12 months
Weight will be measured by a digital scale
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Body fat at 6 months
Time Frame: Baseline and 6 months
Fat mass will be measured by Dual X-ray absorptiometry
Baseline and 6 months
Change from 6 month Body fat at 12 months
Time Frame: 6 months and 12 months
Fat mass will be measured by Dual X-ray absorptiometry
6 months and 12 months
Change from Baseline Body fat at 12 months
Time Frame: Baseline and 12 months
Fat mass will be measured by Dual X-ray absorptiometry
Baseline and 12 months
Change from Baseline Waist circumference at 6 months
Time Frame: Baseline and 6 months
Waist circumference will be measured with a tape measure
Baseline and 6 months
Change from 6 month Waist circumference at 12 months
Time Frame: 6 months and 12 months
Waist circumference will be measured with a tape measure
6 months and 12 months
Change from Baseline Waist circumference at 12 months
Time Frame: Baseline and 12 months
Waist circumference will be measured with a tape measure
Baseline and 12 months
Change from Baseline handgrip strength at 6 months
Time Frame: Baseline and 6 months
Handgrip strength will be measured with a dynamometer
Baseline and 6 months
Change from 6 month handgrip strength at 12 months
Time Frame: 6 months and 12 months
Handgrip strength will be measured with a dynamometer
6 months and 12 months
Change from Baseline handgrip strength at 12 months
Time Frame: Baseline and 12 months
Handgrip strength will be measured with a dynamometer
Baseline and 12 months
Change from Baseline Systolic blood pressure at 6 months
Time Frame: Baseline and 6 months
Systolic blood pressure will be measured with a sphygmomanometer
Baseline and 6 months
Change from 6 month Systolic blood pressure at 12 months
Time Frame: 6 months and 12 months
Systolic blood pressure will be measured with a sphygmomanometer
6 months and 12 months
Change from Baseline Systolic blood pressure at 12 months
Time Frame: Baseline and 12 months
Systolic blood pressure will be measured with a sphygmomanometer
Baseline and 12 months
Change from Baseline Diastolic blood pressure at 6 months
Time Frame: Baseline and 6 months
Diastolic blood pressure will be measured with a sphygmomanometer
Baseline and 6 months
Change from 6 month Diastolic blood pressure at 12 months
Time Frame: 6 months and 12 months
Diastolic blood pressure will be measured with a sphygmomanometer
6 months and 12 months
Change from Baseline Diastolic blood pressure at 12 months
Time Frame: Baseline and 12 months
Diastolic blood pressure will be measured with a sphygmomanometer
Baseline and 12 months
Change from Baseline lipid metabolism at 6 months
Time Frame: Baseline and 6 months
Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state
Baseline and 6 months
Change from 6 month lipid metabolism at 12 months
Time Frame: 6 months and 12 months
Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state
6 months and 12 months
Change from Baseline lipid metabolism at 12 months
Time Frame: Baseline and 12 months
Serum free fatty acids, triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol concentrations will be measured in a fasting state
Baseline and 12 months
Change from Baseline uric acid concentration at 6 months
Time Frame: Baseline and 6 months
Serum uric acid will be measured in a fasting state
Baseline and 6 months
Change from 6 month uric acid concentration at 12 months
Time Frame: 6 months and 12 months
Serum uric acid will be measured in a fasting state
6 months and 12 months
Change from Baseline uric acid concentration at 12 months
Time Frame: Baseline and 12 months
Serum uric acid will be measured in a fasting state
Baseline and 12 months
Change from Baseline homocysteine concentration at 6 months
Time Frame: Baseline and 6 months
Serum homocysteine will be measured in a fasting state
Baseline and 6 months
Change from 6 month homocysteine concentration at 12 months
Time Frame: 6 months and 12 months
Serum homocysteine will be measured in a fasting state
6 months and 12 months
Change from Baseline homocysteine concentration at 12 months
Time Frame: Baseline and 12 months
Serum homocysteine will be measured in a fasting state
Baseline and 12 months
Change from Baseline glucose metabolism at 6 months
Time Frame: Baseline and 6 months
Serum glucose levels will be measured in a fasting state
Baseline and 6 months
Change from 6 month glucose metabolism at 12 months
Time Frame: 6 months and 12 months
Serum glucose levels will be measured in a fasting state
6 months and 12 months
Change from Baseline glucose metabolism at 12 months
Time Frame: Baseline and 12 months
Serum glucose levels will be measured in a fasting state
Baseline and 12 months
Change from Baseline insulin concentration at 6 months
Time Frame: Baseline and 6 months
Serum insulin levels will be measured in a fasting state
Baseline and 6 months
Change from 6 month insulin concentration at 12 months
Time Frame: 6 months and 12 months
Serum insulin levels will be measured in a fasting state
6 months and 12 months
Change from Baseline insulin concentration at 12 months
Time Frame: Baseline and 12 months
Serum insulin levels will be measured in a fasting state
Baseline and 12 months
Change from Baseline Hemoglobin A1c concentration at 6 months
Time Frame: Baseline and 6 months
Serum Hemoglobin A1c will be measured in a fasting state
Baseline and 6 months
Change from 6 month Hemoglobin A1c concentration at 12 months
Time Frame: 6 months and 12 months
Serum Hemoglobin A1c will be measured in a fasting state
6 months and 12 months
Change from Baseline Hemoglobin A1c concentration at 12 months
Time Frame: Baseline and 12 months
Serum Hemoglobin A1c will be measured in a fasting state
Baseline and 12 months
Change from Baseline liver function at 6 months
Time Frame: Baseline and 12 months
Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state
Baseline and 12 months
Change from 6 month liver function at 12 months
Time Frame: 6 months and 12 months
Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state
6 months and 12 months
Change from Baseline liver function at 12 months
Time Frame: Baseline and 12 months
Serum aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, total bilirubin, direct bilirubin, alkaline phosphatase, creatinine, total protein, albumin, prothrombin will be measured in a fasting state
Baseline and 12 months
Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 6 months
Time Frame: Baseline and 6 months
Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state
Baseline and 6 months
Change from 6 month fibroblast growth factor 21 (FGF21) concentration at 12 months
Time Frame: 6 months and 12 months
Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state
6 months and 12 months
Change from Baseline fibroblast growth factor 21 (FGF21) concentration at 12 months
Time Frame: Baseline and 12 months
Plasma FGF21 is a specific biomarker of NAFLD and will be measured in a fasting state
Baseline and 12 months
Change from Baseline cytokeratin-18 (CK18) concentration at 6 months
Time Frame: Baseline and 6 months
Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state
Baseline and 6 months
Change from 6 month cytokeratin-18 (CK18) concentration at 12 months
Time Frame: 6 months and 12 months
Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state
6 months and 12 months
Change from Baseline cytokeratin-18 (CK18) concentration at 12 months
Time Frame: Baseline and 12 months
Plasma CK18 is a specific biomarker of NAFLD and will be measured in a fasting state
Baseline and 12 months
Change from Baseline C-reactive protein (CRP) concentration at 6 months
Time Frame: Baseline and 6 months
Plasma CRP will be assessed to determine inflammatory status
Baseline and 6 months
Change from 6 month C-reactive protein (CRP) concentration at 12 months
Time Frame: 6 months and 12 months
Plasma CRP will be assessed to determine inflammatory status
6 months and 12 months
Change from Baseline C-reactive protein (CRP) concentration at 12 months
Time Frame: Baseline and 12 months
Plasma CRP will be assessed to determine inflammatory status
Baseline and 12 months
Change from Baseline interleukin 6 (IL-6) concentration at 6 months
Time Frame: Baseline and 6 months
Plasma IL-6 will be assessed to determine inflammatory status
Baseline and 6 months
Change from 6 month interleukin 6 (IL-6) concentration at 12 months
Time Frame: 6 months and 12 months
Plasma IL-6 will be assessed to determine inflammatory status
6 months and 12 months
Change from Baseline interleukin 6 (IL-6) concentration at 12 months
Time Frame: Baseline and 12 months
Plasma IL-6 will be assessed to determine inflammatory status
Baseline and 12 months
Change from Baseline tumor necrosis factor-α (TNFα) concentration at 6 months
Time Frame: Baseline and 6 months
Plasma TNF-alpha will be assessed to determine inflammatory status
Baseline and 6 months
Change from 6 month tumor necrosis factor-α (TNFα) concentration at 12 months
Time Frame: 6 months and 12 months
Plasma TNF-alpha will be assessed to determine inflammatory status
6 months and 12 months
Change from Baseline tumor necrosis factor-α (TNFα) concentration at 12 months
Time Frame: Baseline and 12 months
Plasma TNF-alpha will be assessed to determine inflammatory status
Baseline and 12 months
Change from Baseline leptin concentration at 6 months
Time Frame: Baseline and 6 months
Plasma leptin will be assessed to determine inflammatory status
Baseline and 6 months
Change from 6 month leptin concentration at 12 months
Time Frame: 6 months and 12 months
Plasma leptin will be assessed to determine inflammatory status
6 months and 12 months
Change from Baseline leptin concentration at 12 months
Time Frame: Baseline and 12 months
Plasma leptin will be assessed to determine inflammatory status
Baseline and 12 months
Change from Baseline adiponectin concentration at 6 months
Time Frame: Baseline and 6 months
Plasma leptin will be assessed to determine inflammatory status
Baseline and 6 months
Change from 6 month adiponectin concentration at 12 months
Time Frame: Baseline and 12 months
Plasma adiponectin will be assessed to determine inflammatory status
Baseline and 12 months
Change from Baseline adiponectin concentration at 12 months
Time Frame: Baseline and 12 months
Plasma adiponectin will be assessed to determine inflammatory status
Baseline and 12 months
Change from Baseline LDL-oxidized concentration at 6 months
Time Frame: Baseline and 6 months
LDL-ox will be assessed to determine oxidative status
Baseline and 6 months
Change from 6 month LDL-oxidized concentration at 12 months
Time Frame: 6 months and 12 months
LDL-ox will be assessed to determine oxidative status
6 months and 12 months
Change from Baseline LDL-oxidized concentration at 12 months
Time Frame: Baseline and 12 months
LDL-ox will be assessed to determine oxidative status
Baseline and 12 months
Change from Baseline Malondialdehyde concentration at 6 months
Time Frame: Baseline and 6 months
Plasma malondialdehyde will be assessed to determine oxidative status
Baseline and 6 months
Change from 6 month Malondialdehyde concentration at 12 months
Time Frame: 6 months and 12 months
Plasma malondialdehyde will be assessed to determine oxidative status
6 months and 12 months
Change from Baseline Malondialdehyde concentration at 12 months
Time Frame: Baseline and 12 months
Plasma malondialdehyde will be assessed to determine oxidative status
Baseline and 12 months
Change from Baseline plasma antioxidant capacity at 6 months
Time Frame: Baseline and 6 months
Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)
Baseline and 6 months
Change from 6 month plasma antioxidant capacity at 12 months
Time Frame: 6 months and 12 months
Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)
6 months and 12 months
Change from Baseline plasma antioxidant capacity at 12 months
Time Frame: Baseline and 12 months
Plasma antioxidant capacity will be assessed by measuring the ferric reducing ability of plasma (FRAP)
Baseline and 12 months
Change from Baseline Hepatic echography at 6 months
Time Frame: Baseline and 6 months
Echography will be carried out to analyze liver steatosis
Baseline and 6 months
Change from 6 month Hepatic echography at 12 months
Time Frame: 6 months and 12 months
Echography will be carried out to analyze liver steatosis
6 months and 12 months
Change from Baseline Hepatic echography at 12 months
Time Frame: Baseline and 12 months
Echography will be carried out to analyze liver steatosis
Baseline and 12 months
Change from Baseline Hepatic elastography at 6 months
Time Frame: Baseline and 6 months
Elastography will be carried out to analyze liver fibrosis
Baseline and 6 months
Change from 6 month Hepatic elastography at 12 months
Time Frame: 6 months and 12 months
Elastography will be carried out to analyze liver fibrosis
6 months and 12 months
Change from Baseline Hepatic elastography at 12 months
Time Frame: Baseline and 12 months
Elastography will be carried out to analyze liver fibrosis
Baseline and 12 months
Change from Baseline Hepatic Magnetic Resonance Imaging at 6 months
Time Frame: Baseline and 6 months
Magnetic Resonance Imaging will be carried out to analyze liver status
Baseline and 6 months
Change from 6 month Hepatic Magnetic Resonance Imaging at 12 months
Time Frame: 6 months and 12 months
Magnetic Resonance Imaging will be carried out to analyze liver status
6 months and 12 months
Change from Baseline Hepatic Magnetic Resonance Imaging at 12 months
Time Frame: Baseline and 12 months
Magnetic Resonance Imaging will be carried out to analyze liver status
Baseline and 12 months
Change from Baseline White blood cell count at 6 months
Time Frame: Baseline and 6 months
White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.
Baseline and 6 months
Change from 6 month White blood cell count at 12 months
Time Frame: 6 months and 12 months
White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.
6 months and 12 months
Change from Baseline White blood cell count at 12 months
Time Frame: Baseline and 12 months
White blood cell count includes: Leucocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophil, Basophils.
Baseline and 12 months
Change from Baseline blood rheological properties at 6 months
Time Frame: Baseline and 6 months
Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit
Baseline and 6 months
Change from 6 month blood rheological properties at 12 months
Time Frame: 6 months and 12 months
Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit
6 months and 12 months
Change from Baseline blood rheological properties at 12 months
Time Frame: Baseline and 12 months
Red blood cell count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelet count, platelet distribution width, mean platelet volume, plateletcrit
Baseline and 12 months
Change from Baseline Physical activity level at 6 months
Time Frame: Baseline and 6 months
Physical activity will be assessed by accelerometers
Baseline and 6 months
Change from 6 months Physical activity level at 12 months
Time Frame: 6 months and 12 months
Physical activity will be assessed accelerometers
6 months and 12 months
Change from Baseline Physical activity level at 12 months
Time Frame: Baseline and 12 months
Physical activity will be assessed by accelerometers
Baseline and 12 months
Change from Baseline Minnesota Physical Activity test at 6 months
Time Frame: Baseline and 6 months
Physical activity assessed by Minnesota Physical Activity test
Baseline and 6 months
Change from 6 month Minnesota Physical Activity test at 12 months
Time Frame: 6 months and 12 months
Physical activity assessed by Minnesota Physical Activity test
6 months and 12 months
Change from Baseline Minnesota Physical Activity test at 12 months
Time Frame: Baseline and 12 months
Physical activity assessed by Minnesota Physical Activity test
Baseline and 12 months
Change from Baseline number of steps at 6 months
Time Frame: Baseline and 6 months
Physical activity assessed by Pedometers
Baseline and 6 months
Change from 6 month number of steps at 12 months
Time Frame: 6 months and 12 months
Physical activity assessed by Pedometers
6 months and 12 months
Change from Baseline number of steps at 12 months
Time Frame: Baseline and 12 months
Physical activity assessed by Pedometers
Baseline and 12 months
Change from Baseline chair test at 6 months
Time Frame: Baseline and 6 months
Physical activity assessed by the chair test
Baseline and 6 months
Change from 6 month chair test at 12 months
Time Frame: 6 months and 12 months
Physical activity assessed by the chair test
6 months and 12 months
Change from Baseline chair test at 12 months
Time Frame: Baseline and 12 months
Physical activity assessed by the chair test
Baseline and 12 months
Change from Baseline sleep quality at 6 months
Time Frame: Baseline and 12 months
Sleep information will be assessed by the Pittsburgh Sleep Quality Index
Baseline and 12 months
Change from 6 month sleep quality at 12 months
Time Frame: 6 months and 12 months
Sleep information will be assessed by the Pittsburgh Sleep Quality Index
6 months and 12 months
Change from Baseline sleep quality at 12 months
Time Frame: Baseline and 12 months
Sleep information will be assessed by the Pittsburgh Sleep Quality Index
Baseline and 12 months
Change from Baseline Depressive symptoms at 6 months
Time Frame: Baseline and 6 months
Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)
Baseline and 6 months
Change from 6 month Depressive symptoms at 12 months
Time Frame: 6 months and 12 months
Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)
6 months and 12 months
Change from Baseline Depressive symptoms at 12 months
Time Frame: Baseline and 12 months
Depressive symptoms will be assessed by the Beck Depression Inventory (BDI)
Baseline and 12 months
Change from Baseline Anxiety symptoms at 6 months
Time Frame: Baseline and 6 months
Anxiety symptoms will be assessed by State Anxiety test (STAI)
Baseline and 6 months
Change from 6 month Anxiety symptoms at 12 months
Time Frame: 6 months and 12 months
Anxiety symptoms will be assessed by State Anxiety test (STAI)
6 months and 12 months
Change from Baseline Anxiety symptoms at 12 months
Time Frame: Baseline and 12 months
Anxiety symptoms will be assessed by State Anxiety test (STAI)
Baseline and 12 months
Single Nucleotide polymorphisms (SNPs)
Time Frame: Baseline
Single nucleotide polymorphisms will be determined by Genomic DNA from oral epithelial cells
Baseline
Change from Baseline DNA methylation at 6 months
Time Frame: Baseline and 6 months
Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development
Baseline and 6 months
Change from 6 month DNA methylation at 12 months
Time Frame: 6 months and 12 months
Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development
6 months and 12 months
Change from Baseline DNA methylation at 12 months
Time Frame: Baseline and 12 months
Epigenetics will be assessed by changes in DNA methylation of genes related with NAFLD development
Baseline and 12 months
Change from Baseline microRNAs at 6 months
Time Frame: Baseline and 6 months
Transcriptomic will be assessed by changes in miRNAs
Baseline and 6 months
Change from 6 month microRNAs at 12 months
Time Frame: 6 months and 12 months
Transcriptomic will be assessed by changes in miRNAs
6 months and 12 months
Change from Baseline microRNAs at 12 months
Time Frame: Baseline and 12 months
Transcriptomic will be assessed by changes in miRNAs
Baseline and 12 months
Change from Baseline Gut microbiota composition at 6 months
Time Frame: Baseline and 6 months
Gut microbiota composition will be analyzed
Baseline and 6 months
Change from 6 month Gut microbiota composition at 12 month
Time Frame: 6 months and 12 months
Gut microbiota composition will be analyzed
6 months and 12 months
Change from Baseline Gut microbiota composition at 12 month
Time Frame: Baseline and 12 months
Gut microbiota composition will be analyzed
Baseline and 12 months
Change from Baseline metabolites composition of urine at 6 months
Time Frame: Baseline and 6 months
Metabolites composition of urine will be analyzed
Baseline and 6 months
Change from 6 month metabolites composition of urine at 12 months
Time Frame: 6 months and 12 months
Metabolites composition of urine will be analyzed
6 months and 12 months
Change from Baseline metabolites composition of urine at 12 months
Time Frame: Baseline and 12 months
Metabolites composition of urine will be analyzed
Baseline and 12 months
Change from Baseline metabolites composition of serum at 6 months
Time Frame: Baseline and 6 months
Metabolites composition of serum will be analyzed
Baseline and 6 months
Change from 6 month metabolites composition of serum at 12 months
Time Frame: 6 months and 12 months
Metabolites composition of serum will be analyzed
6 months and 12 months
Change from Baseline metabolites composition of serum at 12 months
Time Frame: Baseline and 12 months
Metabolites composition of serum will be analyzed
Baseline and 12 months
Change from Baseline dietary intake at 6 months
Time Frame: Baseline and 6 months
Dietary intake will be assessed by means of food frequency questionnaire
Baseline and 6 months
Change from 6 month dietary intake at 12 months
Time Frame: 6 months and 12 months
Dietary intake will be assessed by means of food frequency questionnaire
6 months and 12 months
Change from Baseline dietary intake at 12 months
Time Frame: Baseline and 12 months
Dietary intake will be assessed by means of food frequency questionnaire
Baseline and 12 months
Assessment of dietary adherence at Baseline
Time Frame: Baseline
Dietary adherence will be assessed by means of 3 day weighed food records
Baseline
Assessment of dietary adherence at 6 months
Time Frame: 6 months
Dietary adherence will be assessed by means of 3 day weighed food records
6 months
Assessment of dietary adherence at 12 months
Time Frame: 12 months
Dietary adherence will be assessed by means of 3 day weighed food records
12 months
Change from Baseline satiety index at 6 months
Time Frame: Baseline and 6 months
Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale
Baseline and 6 months
Change from 6 month satiety index at 12 months
Time Frame: 6 months and 12 months
Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale
6 months and 12 months
Change from Baseline satiety index at 12 months
Time Frame: Baseline and 12 months
Satiety index/appetite will be assessed by using the 100 mm Visual Analogue Scale
Baseline and 12 months
Change from Baseline life quality index at 6 months
Time Frame: Baseline and 6 months
Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire
Baseline and 6 months
Change from 6 month life quality index at 12 months
Time Frame: 6 months and 12 months
Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire
6 months and 12 months
Change from Baseline life quality index at 12 months
Time Frame: Baseline and 12 months
Life quality index will be assessed by means of the Short Form 36 (SF-36) questionnaire
Baseline and 12 months
Change from Baseline Ghrelin concentration at 6 months
Time Frame: Baseline and 6 months
Serum Active Ghrelin will be determined to assess satiety
Baseline and 6 months
Change from 6 month Ghrelin concentration at 12 months
Time Frame: 6 months and 12 months
Serum Active Ghrelin will be determined to assess satiety
6 months and 12 months
Change from Baseline Ghrelin concentration at 12 months
Time Frame: Baseline and 12 months
Serum Active Ghrelin will be determined to assess satiety
Baseline and 12 months
Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 6 months
Time Frame: Baseline and 6 months
Serum active glucagon-like peptide-1 will be determined to assess satiety
Baseline and 6 months
Change from 6 month glucagon-like peptide-1 (GLP-1) concentration at 12 months
Time Frame: 6 months and 12 months
Serum active glucagon-like peptide-1 will be determined to assess satiety
6 months and 12 months
Change from Baseline glucagon-like peptide-1 (GLP-1) concentration at 12 months
Time Frame: Baseline and 12 months
Serum active glucagon-like peptide-1 will be determined to assess satiety
Baseline and 12 months
Change from Baseline Dopamine concentration at 6 months
Time Frame: Baseline and 6 months
Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 6 months
Change from 6 month Dopamine concentration at 12 months
Time Frame: 6 months and 12 months
Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)
6 months and 12 months
Change from Baseline Dopamine concentration at 12 months
Time Frame: Baseline and 12 months
Peripheral Dopamine concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 12 months
Change from Baseline Dopac concentration at 6 months
Time Frame: Baseline and 6 months
Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 6 months
Change from 6 month Dopac concentration at 12 months
Time Frame: 6 months and 12 months
Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)
6 months and 12 months
Change from Baseline Dopac concentration at 12 months
Time Frame: Baseline and 12 months
Peripheral Dopac concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 12 months
Change from Baseline Serotonin (5-HT) concentration at 6 months
Time Frame: Baseline and 6 months
Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 6 months
Change from 6 month Serotonin (5-HT) concentration at 12 months
Time Frame: 6 months and 12 months
Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)
6 months and 12 months
Change from Baseline Serotonin (5-HT) concentration at 12 months
Time Frame: Baseline and 12 months
Peripheral Serotonin concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 12 months
Change from Baseline Noradrenaline concentration at 6 months
Time Frame: Baseline and 6 months
Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 6 months
Change from 6 month Noradrenaline concentration at 12 months
Time Frame: 6 months and 12 months
Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)
6 months and 12 months
Change from Baseline Noradrenaline concentration at 12 months
Time Frame: Baseline and 12 months
Peripheral Noradrenaline concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 12 months
Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 6 months
Time Frame: Baseline and 6 months
Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 6 months
Change from 6 month 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months
Time Frame: 6 months and 12 months
Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC)
6 months and 12 months
Change from Baseline 5-hydroxyindoleacetic acetic (5-HIAAC) concentration at 12 months
Time Frame: Baseline and 12 months
Peripheral 5-hydroxyindoleacetic acetic concentration will be analysed using high-performance liquid chromatography (HPLC)
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: M. Angeles Zulet, PhD, Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
  • Study Director: J. Alfredo Martínez, MD, PhD, Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
  • Study Director: Itziar Abete, PhD, Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
  • Study Chair: Fermín I Milagro, PhD, Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
  • Study Chair: J. Ignacio Riezu, PhD, Centre for Nutrition Research, University of Navarra.
  • Study Chair: Mariana Elorz, MD, Clinica Universidad de Navarra
  • Study Chair: J. Ignacio Herrero, PhD, Clinica Universidad de Navarra
  • Study Chair: Jorge Quiroga, PhD, Clinica Universidad de Navarra
  • Study Chair: Alberto Benito, PhD, Clinica Universidad de Navarra
  • Study Chair: Carmen Fuertes, Clinica Universidad de Navarra
  • Study Chair: Santiago Navas, PhD, Centre for Nutrition Research, University of Navarra. CIBER Obesity and Physiopathology of Nutrition (CIBERobn), Institute of Health Carlos III, Madrid, Spain
  • Study Chair: Eva Almirón, PhD, Centre for Nutrition Research, University of Navarra.
  • Study Chair: Berta Araceli Marín, University of Navarra
  • Study Chair: Irene Cantero, University of Navarra
  • Study Chair: Maria Vanessa Bullon, University of Navarra
  • Study Chair: Blanca Martínez de Morentín, MD, University of Navarra
  • Study Chair: Salomé Pérez, University of Navarra
  • Study Chair: Veronica Ciaurriz, University of Navarra
  • Study Chair: Ana Martínez, MD, Complejo Hospitalario de Navarra
  • Study Chair: Juan Uriz, PhD, Complejo Hospitalario de Navarra
  • Study Chair: María Pilar Huarte, PhD, Complejo Hospitalario de Navarra
  • Study Chair: J. Ignacio Monreal, MD, PhD, Clinica Universidad de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on Control diet

3
Subscribe