Study of the Intestinal Microbiota During a Real Life Dietary Intervention in Subjects With Overweight or Obesity

Overweight and Obesity Clinical Trial

— GUTINSIDE  

Official title:

Study of the Intestinal Microbiota During a Real Life Dietary Intervention in Subjects With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822948
• Other study ID #: GUT201801
• Status: Completed
• Start date: June 6, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: April 2021
• Source: Integrative Phenomics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Worldwide, 13% of the population had obesity in 2016 and overweight and obesity are recognized as the fifth leading risk factor for death (roughly 5 million deaths per year). In the United States alone, a recent study predicts that over half of the population will have obesity in 2030. At the global level, overweight and obesity are also estimated to account for 44% of diabetes, 23% of heart disease and between 7% to 41% of cancer cases, in addition to numerous other pathologies, including neurological disorders. While obesity and overweight are classified as a general disease (i.e. a body mass index (BMI) above 25 kg/m2 or 30 kg/m2, respectively), there are large variabilities between classifications of obesity observed. For example, sub-populations of obesity present either a rapid or delayed onset of other chronic diseases, such as diabetes or cardiovascular disease.

Many studies show that lifestyle interventions are effective in improving overweight and obesity through weight loss, but with very large inter-individual variability, especially in the long-term. These interventions and the respective observed weight loss are also shown to reduce the risk of other cardiovascular or metabolic diseases, demonstrating the importance of weight loss for future quality of life Interestingly, there is a large variation in weight loss when implementing the same dietary or lifestyle changes, even when many factors are accounted for in clinical studies. Similar variable weight loss or metabolic responses are also observed for other obesity treatments, such as pharmaceutical or surgical interventions. Therefore, in order to prevent and treat overweight and obesity, it is critical to progress in the understanding of individual variations in responses (trajectories) to weight loss programs.

While biological, environmental, and behavioral factors indeed drive personal responses, recent advances have allowed more insight into how the human body processes these stimuli, namely through microorganisms inhabiting the gastrointestinal tract. Over the last 10 years, the gut microbiota, the 100 billion bacterial cells inhabiting our intestines, has emerged as a recognized factor contributing to our health. Given its access to the food and medicine consumed by an individual, the gut microbiota can be seen as a "super integrator" highly sensitive to our environmental and lifestyle changes. Accumulating evidence has highlighted that the gut microbiota translates these environmental changes by altering its diversity of bacteria or functions and producing molecules that interact with organs and the brain.

As part of a weight loss program conducted within the standard of care in a network of clinical centers across France, the investigators set out to establish a cohort to examine the relative contribution of clinical, nutritional, and lifestyle factors related to individual's weight loss success with an emphasis on evaluating the gut microbiome of individuals.

Within this context, the investigators are testing whether an individuals' microbiota profile before the real-life dietary intervention influences weight loss responses and changes in metabolic health parameters to a standardized weight loss diet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1855
• Est. completion date: December 15, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject having signed the informed consent

• Male or female, 18 to 65 years of age

• Body Mass Index (BMI) greater than or equal to 25 kg/m²

Exclusion Criteria:

• Pregnant woman (positive serum pregnancy test for selection) or breastfeeding,

• Infected subject under anti-retroviral treatment

• Subject with severe hepatic and / or renal insufficiency (awaiting transplant)

• Subject with anemia <10 g / dl

• Subject with known gastrointestinal illness

• Subject having undergone bariatric surgery

• Subject with a weight loss > 10% of body weight during the last 3 months (special diet: low calorie diet (slimming diet), special diet (vegetarians, vegans, nutritional supplements) before treatment),

• Subject taking pro or prebiotics before treatment

• Subject having taken antibiotics in the 2 months preceding inclusion

• Subject participating in another clinical study,

• Subject not enrolled in the French national healthcare system

• Subject not compliing with the exclusion period from the study in which he/she has previously participated

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
France	RNPC	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Phenomics	RNPC (Rééducation Nutritionnelle et Psycho-Comportementale) Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota composition	Assessment of gut microbiota taxonomic features (e.g. phyla, genus, species)	Baseline and Estimated: 105 days
Primary	Bodyweight change	Bodyweight change calculated relative to baseline body weight	8 weeks
Secondary	Gut microbiota richness and diversity	Assessment as gene counts and species	Baseline and Estimated: 105 days
Secondary	Dietary assessment	Assessment via standardized Food Frequency Questionnaire	Baseline
Secondary	Physical activity	Assessment via standardized questionnaire	Baseline and Estimated: 105 days and 8 months
Secondary	General health and well-being	Assessment via standardized questionnaire	Baseline and Estimated: 105 days and 8 months
Secondary	Eating behavior	Assessment via standardized questionnaire	Baseline and Estimated: 105 days and 8 months
Secondary	Body Mass Index (BMI)	Height and bodyweight will be measured to report BMI in (kg/m^2)	Baseline and Estimated: 105 days and 8 months
Secondary	Bodyweight	Body weight (kg) measured bi-weekly	Baseline, Estimated: 105 days and 8 months
Secondary	Waist circumference	Waist circumference (cm) measured bi-weekly	Baseline, Estimated: 105 days and 8 months
Secondary	Body fat mass	Body fat mass assessed by bioelectrical impedance	Baseline and Estimated: 105 days
Secondary	Muscle mass	Muscle mass assessed by bioelectrical impedance	Baseline and Estimated: 105 days
Secondary	Water weight	Water weight assessed by bioelectrical impedance	Baseline and Estimated: 105 days
Secondary	Blood glucose	Fasting blood glucose	Baseline and Estimated: 105 days
Secondary	Insulin	Fasting insulin	Baseline and Estimated: 105 days
Secondary	HbA1c	Fasting HbA1c	Baseline and Estimated: 105 days
Secondary	Blood lipids	Fasting triglycerides, LDL, HDL	Baseline and Estimated: 105 days
Secondary	Blood pressure	Systolic and diastolic blood pressure in mmHg	Baseline and Estimated: 105 days
Secondary	Liver enzymes	Fasting levels of AST, ALT, GGT	Baseline and Estimated: 105 days