- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793896
Beneficial Effects of Exercise and Healthy Diets on Muscle and Adipose Tissue
Mitochondrial Biogenesis, Reduction of Muscle Oxidative Damage and Improvement in Adipose Tissue Functional Profile, Account for the Beneficial Effects of Exercise and Healthy Diets
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
METHODOLOGY:
This study will be composed of 2 parts:
I - CROSS SECTIONAL STUDY The aim of this section is to compare men with different body compositions, fat distribution and exercise capacity with respect to their muscle mitochondrial biogenesis, oxidative damage and energy flux regulator molecules, together with their adipose tissue inflammation, adipokine expression and thermogenic potential.
Inclusion criteria :
- male sex
- age 25 - 50 years
- BMI from 20 - 35 kg/mt2
- indication for surgery of an inguinal hernia
Exclusion criteria:
- diabetes mellitus
- chronic neuromuscular or neurological deficits precluding normal physical activity
- heavy smoking (> 5 cigarettes per day)
- alcohol intake > 30 g/day
- chronic diseases such as cancer, HIV-AIDS, renal, pulmonary, cardiac or hepatic conditions.
Before the operation and after signing a written informed consent, the following assessment will be performed:
- Medical history including medication intake and complete physical examination.
- Dietary recall of habitual intake and calculation of AGEs ingestion.
- Regular physical activity assessment using the International Physical Activity Questionnaire
- Anthropometrics (height, weight, waist circumference)
- Fasting blood sampling for routine determinations (haemoglobin,lipoproteins, creatinine,prothrombin, TSH), AGEs concentrations (CML) free fatty acids, adiponectin and 8- Isoprostanes.
- Fasting and post glucose serum sampling for glucose and insulin measurements, and calculation of Homeostasis Model Assessment (HOMA-IR) and the Matsuda Index for determination of peripheral insulin sensitivity.
- Resting and exercise indirect calorimetry for estimation of resting energy expenditure, respiratory quotient and VO2 max.
- Handgrip and quadriceps muscle strength
- Dual X-Ray Energy Densitometry (DEXA) for estimation of body composition
- CT scan of abdominal region at L4 level for measurement of visceral and subcutaneous fat areas and estimation of liver fat infiltration.
- Ultrasound intensity analysis in thigh ultrasonography indicating muscle fat infiltration. After the initial evaluation, subjects will be classified as with or without the metabolic syndrome, according to the international guidelines guidelines, for further analysis of data.
A few days later, during the surgical procedure, a sample of muscle tissue (approximately 200 mg of internal abdominal oblique) will be obtained for measurement of:
- Fiber type
- Messenger Ribonucleic acid (mRNA) expression of PGC-1-alpha, SIRT-1, UCP-3 and AMPK
- Mitochondrial density by measurement of mitDNA and Cytochrome C activity
- Oxidative damage (8-oxodG, CML and RAGE).
During the same operation, 2 samples of adipose tissue will also be obtained, one subcutaneous (at the site of the incision) and the other preperitoneal (at the inguinal sac), for in vitro studies:
- UCP1 and inflammatory marker (interleukin 6, 1ß, CCL2) expression in mature adipocytes
- Inflammatory profile and adipogenic potential (expression of lipoprotein lipase, PPAR gamma and adiponectin) in cultured preadipocytes
- Adipogenic potential and inflammatory expression profile of LS14 adipose cells exposed to conditioned media from adipose tissue explants.
A small part of these adipose tissue samples will be placed in formaldehyde, fixed and stained with H.E for histologic estimation of adipocyte cell size.
II - INTERVENTION STUDY This section intends to demonstrate the effects of a low-AGEs Mediterranean diet and/or exercise, over skeletal muscle metabolic profile and adipogenic/inflammatory features of adipocytes.
Inclusion criteria:
- Overweight or obese men and women
- Ages 25 - 50 years
- Interest in losing weight
Exclusion criteria:
- weight fluctuations (> 3 k in the last 3 months)
- diabetes mellitus
- chronic neuromuscular or neurologic diseases
- heavy smoking (> 5 cigarettes per day)
- alcohol intake > 30 g/day
- chronic diseases such as cancer, HIV, renal, pulmonary, cardiac or hepatic conditions.
Subjects will be invited to participate in a trial using a Mediterranean low-AGEs diet and/or physical exercise during 3 months. After signing a written informed consent,subjects will be allocated to one of these interventions, which will be randomly selected, and the following assessment will be performed, at baseline and after 3 months of intervention:
- Medical and medication intake history and complete physical examination.
- Dietary recall of habitual intake and calculation of AGEs ingestion.
- Physical activity questionnaire (IPAQ)
- Anthropometrics (height, weight, waist circumference)
- Fasting blood sampling for routine determinations (haemoglobin, lipoproteins, creatinine, prothrombin and TSH), AGEs concentrations (CML), free fatty acids, adiponectin, 8-Isoprostanes and serum for in vitro adipose tissue studies (see below).
- Fasting and post glucose blood sampling for glucose and insulin measurements, and calculation of HOMA-IR and the Matsuda Index for determination of peripheral insulin sensitivity.
- Dual X-Ray Energy Densitometry (DEXA) for estimation of body composition
- CT scan of abdominal region at L4 level for measurement of visceral and subcutaneous fat areas and estimation of liver fat infiltration
- Resting and exercise indirect calorimetry for estimation of resting energy expenditure, respiratory quotient and VO2 max.
- Handgrip and quadriceps muscle strength
- Ultrasound intensity analysis in thigh indicating muscle fat infiltration
- Ultrasound guided quadriceps muscle biopsy to measure mitochondrial density (mitDNA) and expression of PGC-1
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Metropolitan Region
-
Santiago, Metropolitan Region, Chile, 7830490
- Institute of Nutrition & Food Technology (INTA)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
CROSS SECTIONAL: male sex, age 25 -50 years, with BMI ranging from 20 to 35 kg/mt2. INTERVENTION STUDY: Overweight or obese men and women aged 25 - 50 years interested in losing weight,will
Exclusion Criteria:
CROSS SECTIONAL : diabetes mellitus, chronic neuromuscular or neurological deficits precluding normal physical activity, heavy smoking (> 5 cigarettes per day), alcohol intake > 30 g/day and chronic diseases such as cancer, HIV-AIDS, renal, pulmonary, cardiac or hepatic conditions.
INTERVENTION STUDY: weight fluctuations (> 3 k in the last 3 months), diabetes mellitus, chronic neuromuscular or neurologic diseases, heavy smoking (> 5 cigarettes per day) and alcohol intake > 30 g/day, and chronic diseases such as cancer, HIV, renal, pulmonary, cardiac or hepatic conditions.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: control period
control period with no intervention.
Comparison of parameters at entrance and one month later without any intervention
|
Analysis at recruitment and after a month without any intervention
Other Names:
|
Experimental: Diet group
Mediterranean diet prescription during 3 months
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selected subjects will adopt a Mediterranean low-AGE diet.
We will not include red wine in the Mediterranean diet (7 Kilocalories (KCal)/g), in order to attain more weight loss.
Each subject will be instructed to reduce 500 Kcal of their estimated total daily energy requirements, so theoretically they will be able to reduce 5 - 10 % of their body weight in 3 months.
Other Names:
|
Experimental: Exercise group
Subjects will be trained 3 times a week during 3 months
|
The intervention will consist of 3 weekly 1 hour sessions (5 minutes of preconditioning, followed by 20 minutes cycling, brisk walking or jogging at 65-70 % maximal aerobic capacity, then 25 minutes resistance weight-lifting exercises and finally 10 minutes of stretching).
Exercise intensity will be increased weekly according to the Borg Scale intensity.
The exercise intervention will be supervised by physical education teachers, registering attendance at every session.
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Experimental: Diet + Exercise
Both a dietary prescription plus exercise training during 3 months
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these patients will be incorporated to receive both Mediterranean diet plus exercise interventions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mitochondrial density in muscle tissue
Time Frame: 3 months
|
As described in the methodology section
|
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Oxidative damage in muscle tissue
Time Frame: 3 months
|
As described in the methodology section
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Pia de la Maza, Professor, University of Chile
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fondecyt 1130284
- INSTITUTE OF NUTRITION 2013 (Other Identifier: INTA)
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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