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.
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.
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.
- Conditions
- Overweight and Obesity
- Medical subject headings
- Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Bodyweight change
Bodyweight change calculated relative to baseline body weight
Measured: 8 weeks
Secondary outcomes (17)
Gut microbiota richness and diversity
Assessment as gene counts and species
Measured: Baseline and Estimated: 105 days
Dietary assessment
Assessment via standardized Food Frequency Questionnaire
Measured: Baseline
Physical activity
Assessment via standardized questionnaire
Measured: Baseline and Estimated: 105 days and 8 months
General health and well-being
Assessment via standardized questionnaire
Measured: Baseline and Estimated: 105 days and 8 months
Eating behavior
Assessment via standardized questionnaire
Measured: Baseline and Estimated: 105 days and 8 months
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
Bodyweight
Body weight (kg) measured bi-weekly
Measured: Baseline, Estimated: 105 days and 8 months
Waist circumference
Waist circumference (cm) measured bi-weekly
Measured: Baseline, Estimated: 105 days and 8 months
Body fat mass
Body fat mass assessed by bioelectrical impedance
Measured: Baseline and Estimated: 105 days
Muscle mass
Muscle mass assessed by bioelectrical impedance
Measured: Baseline and Estimated: 105 days
Water weight
Water weight assessed by bioelectrical impedance
Measured: Baseline and Estimated: 105 days
Blood glucose
Fasting blood glucose
Measured: Baseline and Estimated: 105 days
Insulin
Fasting insulin
Measured: Baseline and Estimated: 105 days
HbA1c
Fasting HbA1c
Measured: Baseline and Estimated: 105 days
Blood lipids
Fasting triglycerides, LDL, HDL
Measured: Baseline and Estimated: 105 days
Blood pressure
Systolic and diastolic blood pressure in mmHg
Measured: Baseline and Estimated: 105 days
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.
- First posted30 Mar 2021
- Study start6 Jun 2018
- Primary completion20 Oct 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Integrative Phenomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RNPC (Rééducation Nutritionnelle et Psycho-Comportementale) Network
- Responsible party
- Sponsor
- Investigators
- Odile Fabre, Principal investigator, RNPC
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Intestinal Microbiota During a Real Life Dietary Intervention in Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT04822948
- Acronym / sponsor ID
- GUTINSIDE / GUT201801
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,855 participants (actual)
- Lead sponsor
- Integrative PhenomicsIndustry (pharma, biotech, devices)
- Collaborators
- RNPC (Rééducation Nutritionnelle et Psycho-Comportementale) Network
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals who meet the various inclusion criteria as part of the routine care activity of French RNPC centers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bodyweight change
Time frame: 8 weeks
Bodyweight change calculated relative to baseline body weight
17 secondary outcomes
Gut microbiota richness and diversity
Time frame: Baseline and Estimated: 105 days
Dietary assessment
Time frame: Baseline
Physical activity
Time frame: Baseline and Estimated: 105 days and 8 months
General health and well-being
Time frame: Baseline and Estimated: 105 days and 8 months
Eating behavior
Time frame: Baseline and Estimated: 105 days and 8 months
Body Mass Index (BMI)
Time frame: Baseline and Estimated: 105 days and 8 months
Bodyweight
Time frame: Baseline, Estimated: 105 days and 8 months
Waist circumference
Time frame: Baseline, Estimated: 105 days and 8 months
Body fat mass
Time frame: Baseline and Estimated: 105 days
Muscle mass
Time frame: Baseline and Estimated: 105 days
Water weight
Time frame: Baseline and Estimated: 105 days
Blood glucose
Time frame: Baseline and Estimated: 105 days
Insulin
Time frame: Baseline and Estimated: 105 days
HbA1c
Time frame: Baseline and Estimated: 105 days
Blood lipids
Time frame: Baseline and Estimated: 105 days
Blood pressure
Time frame: Baseline and Estimated: 105 days
Liver enzymes
Time frame: Baseline and Estimated: 105 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile Fabre principal investigator
RNPC
1 site in 1 country: see every site and its status.
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.