Beneficial Effects of Exercise and Healthy Diets on Muscle and Adipose Tissue

NCT01793896 | Terminated DMC

• 2 other identifiers: Fondecyt 1130284INSTITUTE OF NUTRITION 2013
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Both dietary caloric restriction (CR) and physical exercise (PE) exert beneficial effects, which retard or prevent age-related diseases and prolong life span. Subjects with the metabolic syndrome age prematurely, therefore preventive measures should be initiated early. The present study intends to demonstrate that physical exercise and/or Mediterranean diet, in middle aged volunteers with the metabolic syndrome, preserve adequate adipose tissue functionality and retard skeletal muscle aging (assessed by mitochondrial biogenesis and accumulation of ROS), by activating several pathways, homologous to CR. The investigators plan to study this by using two approaches: 1) A cross- sectional model, in which the expression of the mentioned metabolic mediators, indicators of muscle mitochondrial biogenesis and muscle oxidative damage will be compared between men with different body compositions, fat distribution, muscle strength and exercise capacity (VO2max). Also, in these men the investigators will assess the expression of uncoupling protein 1 (UCP1) in subcutaneous white adipose tissue (as a measure of adaptive thermogenesis), and inflammatory markers (Interleukin 1-6, Interleukin 1ß and CCL2 chemokine (C-C motif ligand 2)) in preperitoneal adipose tissue, plus inflammation and adipogenesis potential of their cultured preadipocytes. Moreover, in vitro studies will evaluate the functional effects of exposure of a cell lyne of human adipocyte cells (LS14)to factors secreted by media conditioned by the patients´ adipose tissue explants. 2) A prospective intervention in overweight/moderately obese middle aged volunteers that will be assigned to a weight-maintenance period (as a control group), and then randomly y assigned to a Mediterranean diet, exercise training or diet plus training. Before and after 3 months of intervention the investigators will obtain muscle tissue samples to study the expression of Peroxisome proliferator activated receptor (PPAR) gamma coactivator 1 alpha (PGC1), uncoupling protein 3 (UCP3), AMP activated protein kinase (AMPK), Sirtuin 1 (SIRT-1), mitochondrial DNA and oxidative damage indicators (8-oxo-7,8-dihydro-2-deoxyguanosine (oxodG), carboxymethyllysine (CML and its receptor (RAGE)). In vitro studies will evaluate the effect of circulating factors from the patients (serum) on LS14 inflammatory and adipogenic potential, at baseline and after 3 months of intervention.

Conditions

Metabolic Syndrome

Keywords

Metabolic syndrome; Ageing; Mitochondrial density; Oxidative damage; Inflammatory mediators; AMPK; Adipogenesis

Outcome Measures

Primary Outcomes (1)

• Change in mitochondrial density in muscle tissue

  As described in the methodology section

  3 months

Secondary Outcomes (1)

• Change in Oxidative damage in muscle tissue

  3 months

Study Arms (4)

control period

SHAM COMPARATOR

control period with no intervention. Comparison of parameters at entrance and one month later without any intervention

Behavioral: Control period

Diet group

EXPERIMENTAL

Mediterranean diet prescription during 3 months

Behavioral: Diet Group

Exercise group

EXPERIMENTAL

Subjects will be trained 3 times a week during 3 months

Behavioral: Exercise group

Diet + Exercise

EXPERIMENTAL

Both a dietary prescription plus exercise training during 3 months

Behavioral: Diet + Exercise

Interventions

Control period BEHAVIORAL

Analysis at recruitment and after a month without any intervention

Also known as: Before randomization

control period

Diet Group BEHAVIORAL

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.

Also known as: Mediterranean diet

Diet group

Exercise group BEHAVIORAL

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.

Exercise group

Diet + Exercise BEHAVIORAL

these patients will be incorporated to receive both Mediterranean diet plus exercise interventions

Diet + Exercise

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Institute of Nutrition & Food Technology (INTA)

Santiago, Metropolitan Region, 7830490, Chile

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Diet, Mediterranean; Diet; Exercise

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Pia de la Maza, Professor

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After a placebo phase with no intervention in the first 25 subjects recruited, overweight or obese patients were randomly assigned to one of 3 treatments: hypocaloric diet, high intensity interval training or both interventions simultaneously, for 3 months.

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 18, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

CL (1)