Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S)

May 11, 2016 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Reduction of the Metabolic Syndrome in Navarra-Spain (RESMENA-S) Through an Innovative Multidisciplinary Strategy Based on the Crononutrition and Dietary Training Concepts, in Addition to Both Dietary and Psychological Control

The purpose of this study is to determine whether a dietary pattern based on crononutrition and dietary training, together with dietary and psychological control, can reduce the body weight, improve the oxidative and inflammatory state in subjects with diagnosed metabolic syndrome features and can reduce the prevalence of the Metabolic syndrome in the population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The dietary pattern that characterizes the present nutritional intervention study is based on personalized diet, by elaborating tailoring-diets for each subject regarding his energetic needs and assuring a high adherence to the Mediterranean Diet. Moreover, the diet to be performed will be a hyperproteic diet to guarantee a satiety effect and a lower recovery of the lost weight, in accordance with the results derived from the main European study about nutrition (DIOGENES). The glycemic index/load will be also controlled in the study diet. The increase of the antioxidant capacity of the diet will be increased by the intake of fruits, walnuts and virgin olive oil among other antioxidant containing foods.

The present initiative, based on the traditional diet, aims to integrate the main results obtained from diverse observational epidemiological studies and interventional studies in the dietary pattern of the present study. At the same time, the study will apply the concept of crononutrition by selecting and distributing the foods thorough the day according the physiological needs of each individual.

In addition to the quantitative and qualitative composition of the diet, the study will take into account other important factors such as the behavior habits regarding the food, the frequency of consumption, the size of the eating portions, the distribution of the portions along the day, the feeling of fullness, the eating speed and so on. The aforementioned factors have recently been shown to be related to the gain of weight.

Other non dietary factors, such as smoking habits, sedentary life, socio-economic level, will be also controlled in the present study. Moreover, the project will integrate the dietary support together with psychological support due to the fact that the state of mind has been shown to be associated with the MS in some scientific publications.

Study Type

Interventional

Enrollment (Actual)

109

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 Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • University of Navarra

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

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 35-70 years old
  • Both sexes: Male and Female
  • Metabolic Syndrome according to the IDF(2005)criteria:

Waist circumference cutoffs (male ≥94 cm or female ≥80 cm) plus any two of the following four factors:

  1. Fasting glucose ≥5.55 mmol/L or use of antidiabetic medication
  2. Systolic BP ≥130 mm Hg, diastolic BP ≥85 mm Hg, or use of antihypertensive medication
  3. Fasting triglycerides ≥1.7 mm/L; and HDL-C <1.0 mm/L in men and <1.3 mm/L in women or specific treatment for this lipid abnormality

Exclusion Criteria:

  • Recent follow-up of diets designed for weight loss
  • Unstable weight in the past 3 months
  • Alcoholic and drug dependence
  • Hormonal treatment
  • No stable pharmacological treatment
  • Eating-disordered behaviors
  • Severe physical or mental disability
  • Pregnancy
  • Terminal disease
  • Institutionalization

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crononutrition

Dietary pattern:

  • Personalized diet
  • Caloric restriction (-30% Total energy intake)
  • High adherence to the Mediterranean Diet
  • Macronutrient distribution (30% Protein, 40% Carbohydrates and 30% Fat)
  • Low glycemic index/load
  • Increased antioxidant capacity of the diet
Behavioral: Crononutrition
After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period ("autonomy phase") in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support.
Other Names:
  • RYTHMONUTRITION
  • METABOLIC SYNDROME
  • OBESITY
  • DIABETES
  • CARDIOVASCULAR DISEASE
  • RESMENA-S
Placebo Comparator: American Heart Association

Dietary pattern:

  • Personalized diet
  • Caloric diet (-30% Total energy intake)
  • Macronutrients distribution according to the American Heart Association (AHA) guidelines
Behavioral: American Heart Association
After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period ("autonomy phase") in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support.
Other Names:
  • RESMENA-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: One year

Through this specific nutritional intervention program we will try to reduce the metabolic syndrome features such as waist circumference, body weight and adiposity.

To evaluate the body composition, bioimpedance, DEXA and anthropometry methodology will be used at the beginning and after two months of intervention.
One year
Lipid profile
Time Frame: One year

To evaluate lipid improvements the following measurements will be taking into account:

  • Free fatty acids
  • Total cholesterol
  • HDL-cholesterol
  • LDL-cholesterol
One year
Glucose Profile
Time Frame: One year

To evaluate glucose improvements the following measurements will be taking into account:

  • Glucose
  • Insulin
  • HOMA
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation state
Time Frame: One year

As secondary outcome some inflammatory markers will be analyzed:

  • CRP
  • IL-6
  • TNF-alpha
  • IL-18
  • PAI-1
  • Homocystein
One year
Oxidative stress
Time Frame: One year

As secondary outcome some oxidative stress markers will be analyzed:

  • MDA
  • LDL-OX
  • Total antioxidant capacity (TAC)
One year
Psychological tests
Time Frame: January 2010-November 2011
  • Beck Depression Inventory
  • Stai Trait Anxiety Inventory
  • Mood thermometer visual analogue scale
  • Anxiety thermometer visual analogue scale
  • NEO personality inventory-revised test
January 2010-November 2011
Peripheral neurotransmitters
Time Frame: March-April 2013
  • Dopamine
  • Dopac
  • Serotonin
  • 5-Hydroxyindoleacetic acid
  • Noradrenaline
March-April 2013
Epigenetics
Time Frame: April 2012-July 2014
  • DNA methylation
  • microRNAs expression
April 2012-July 2014
Fatty Liver biomarkers / Non invasive liver scoring system.
Time Frame: May 2016- January 2017

Measurements in fatty liver biomarkers:

Serum transaminases (AST & ALT (U/L)), GGT (U/L) and CK18 (U/L) concentrations will be measured in a fasting state at the beginning, at 2 months and at the end of the intervention.

- A specificif Fatty Liver Index was calculated at the begining, at 2 months and at the end of the intervention.
May 2016- January 2017

Collaborators and Investigators

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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Hospital of Navarra

Investigators

  • Principal Investigator: María Ángeles MA Zulet, PhD, University of Navarra
  • Study Director: José Alfredo JA Martínez, PhD, RN, University of Navarra
  • Study Chair: Itziar I Abete, PhD, University of Navarra
  • Study Chair: Lluis L Forga, PhD, Hospital of Navarra
  • Study Chair: Blanca Esther BE Martínez de Morentin, MD, University of Navarra
  • Study Chair: Santiago S Navas-Carretero, PhD, University of Navarra
  • Study Chair: Rocío R de la Iglesia, M.Sc, University of Navarra
  • Study Chair: Patricia P López Legarrea, M.Sc, University of Navarra
  • Study Chair: Isabel I Bondia-Pons, PhD, University of Navarra
  • Study Chair: Aurora A Perez Cornago, M.Sc, University of Navarra
  • Study Chair: José Luiz JL Marques-Rocha, M.Sc, Universidade Federal de Viçosa
  • Study Chair: Marcos M García-Lacarte, M.Sc, University of Navarra
  • Study Chair: Irene I Cantero, M.Sc, University of 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

January 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESMENA-S

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.

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