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Overweight and ObesityGUTINSIDENCT04822948

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

An observational study of Overweight and Obesity, run by Integrative Phenomics at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight and Obesity
How many people
1,855 participants
Where
1 siteFrance
Study dates
6 Jun 2018to 15 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All individuals who meet the various inclusion criteria as part of the routine care activity of French RNPC centers

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • RNPC

    Marseille

Other trials in France

About this study

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.

Read more

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.

Medical subject headings
Overweight, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bodyweight change

    Bodyweight change calculated relative to baseline body weight

    Measured: 8 weeks

Secondary outcomes (17)
  1. Gut microbiota richness and diversity

    Assessment as gene counts and species

    Measured: Baseline and Estimated: 105 days

  2. Dietary assessment

    Assessment via standardized Food Frequency Questionnaire

    Measured: Baseline

  3. Physical activity

    Assessment via standardized questionnaire

    Measured: Baseline and Estimated: 105 days and 8 months

  4. General health and well-being

    Assessment via standardized questionnaire

    Measured: Baseline and Estimated: 105 days and 8 months

  5. Eating behavior

    Assessment via standardized questionnaire

    Measured: Baseline and Estimated: 105 days and 8 months

  6. Body Mass Index (BMI)

    Height and bodyweight will be measured to report BMI in (kg/m^2)

    Measured: Baseline and Estimated: 105 days and 8 months

  7. Bodyweight

    Body weight (kg) measured bi-weekly

    Measured: Baseline, Estimated: 105 days and 8 months

  8. Waist circumference

    Waist circumference (cm) measured bi-weekly

    Measured: Baseline, Estimated: 105 days and 8 months

  9. Body fat mass

    Body fat mass assessed by bioelectrical impedance

    Measured: Baseline and Estimated: 105 days

  10. Muscle mass

    Muscle mass assessed by bioelectrical impedance

    Measured: Baseline and Estimated: 105 days

  11. Water weight

    Water weight assessed by bioelectrical impedance

    Measured: Baseline and Estimated: 105 days

  12. Blood glucose

    Fasting blood glucose

    Measured: Baseline and Estimated: 105 days

  13. Insulin

    Fasting insulin

    Measured: Baseline and Estimated: 105 days

  14. HbA1c

    Fasting HbA1c

    Measured: Baseline and Estimated: 105 days

  15. Blood lipids

    Fasting triglycerides, LDL, HDL

    Measured: Baseline and Estimated: 105 days

  16. Blood pressure

    Systolic and diastolic blood pressure in mmHg

    Measured: Baseline and Estimated: 105 days

  17. Liver enzymes

    Fasting levels of AST, ALT, GGT

    Measured: Baseline and Estimated: 105 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2021
  2. Study start6 Jun 2018
  3. Primary completion20 Oct 2020
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,855 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04822948
Sponsor's protocol ID
GUT201801
Acronym
GUTINSIDE
Status last verified
Apr 2021
First submitted
3 Mar 2021
Last updated
8 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Obesity, run by Integrative Phenomics at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bodyweight change (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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