Immunometabolic Effects of Non-drug Strategies in the Clinical Management of Obesity: Translational Study

Summary

Forty women aged between 18 and 75 years-old with a BMI\> 30kg/m2 are recruited to participate in the evaluation of their medical management. They participate in an 8-week protocol as part of hospital medical treatment for weight loss at the Oxford Polyclinic in Cannes (IPOCA). The effects of 2 independent variables will be studied: (1) an adapted physical activity program and (2) nutritional supplementation with R-α-Lipoic acid (2x300mg/d) versus placebo (double-blind). The volunteers are randomly assigned to the different groups: Placebo with or without exercise groups and ALA with or without exercise groups. At the start of the protocol (T0), at 4 weeks (T4) and at 8 weeks (T8), various measurements are carried out (physical capacities, nutritional status, body composition, distribution of adipose mass by CT-scan). A venous sample taken for all participants is done at T0, T4 and T8 to investigate the immune profile of circulating T lymphocytes.

This project is part of a translational research project to assess current care and to investigate the immunometabolic effects of a non-drug medical care of obesity (adapted physical activities, nutritional supplementation with α-lipoic acid, quality of food intake).

Conditions

• Obesity
• Obesity, Abdominal
• Obesity, Visceral
• Female

Interventions

DIETARY_SUPPLEMENT

Alpha lipoic acid (plus full hospitalization)

Women are included in an 8-weeks randomized double-blind against placebo supplementation study with ALA (eight per group) according to the following criteria: Inclusion criteria: BMI\> 30; aged between 18 and 75 years. Non-inclusion criteria: HLA-DRB1\*04-03/06 polymorphisms; recent hospitalization (\<1 month); food supplement based on antioxidant; medicated in fibrate / telmisartan (modulator of PPARs); patients presenting an acute inflammatory state. Exclusion criteria: Pregnant and/or lactating women; not affiliated with social security; not mutual health insurance; person deprived of liberty; participation in clinical research in the last 6 months. Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. α-LA (2x300mg/day of R-ALA) was administered double-blinded in the form of 2 capsules apart from meals.

DIETARY_SUPPLEMENT

Placebo (full hospitalization: dietary monitoring with an adapted physical activity program)

Women are included in an 8-weeks randomized in placebo group. Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. Placebo (2x300mg/day) was administered double-blinded in the form of 2 capsules apart from meals.

Sponsors & Collaborators

• Institut Polyclinique de Cannes (IPOCA)

  collaborator INDUSTRY

• Fauqué

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-02

Primary Completion

2020-02-28

Completion

2020-03-16

Countries

• France

Study Locations