Severe ObesityGUTERRINGNCT05832190
Correcting GUT MicrobioTa by Combined Supplementation of FibERs and BIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes
A study testing Biotin supplement and Fiber supplement in people with Severe Obesity and Metabolic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Bariatric surgery improves health outcomes with a maximal weight loss on average occurring 1 year after surgery but with dramatic between-subjects variability in weight loss (ranging from 20 to 160% excess weight loss) for reasons that remain to be elucidated. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Obesity, Metabolic Syndrome
- What is being tested?
- Biotin supplement and Fiber supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2023to 24 Dec 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years and < 60 years
- BMI ≥ 40 kg/m² or BMI > 35 kg/m² with at least one comorbidity belonging to metabolic syndrome (hyperglycemia (fasting glycemia > 1g/l, Non diabetic with HbA1C<7% without antidiabetic treatment), dyslipidemia (HDL-cholesterol <0.5 g/l or receiving treatment against dyslipidemia), or increased blood pressure (SBP >13, DBP>9 or treated by antihypertensive drug)), or sleep apnoea, weight stable (less than 3 kg variation in the 2 months before
- Usual Fiber intake < 20g/day in food consumption evaluated by 24h recall
- Signature of the informed consent
- Effective contraception in women of childbearing age
- Subject with health insurance (except AME)
Who cannot join
- Patients receiving antibiotics (ATB) at the selection time or within the 2 previous months.
- (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- Type 1 or type 2 diabetes
- HIV, HBV, HCV
- Gastrointestinal disease: Acute or chronic diarrhea (i.e. more than 3 liquid or fluid stools/day)
- Previous history of gastrointestinal neoplasia or polyps
Show all 12Show fewer
- Factors that may affect the composition of the intestinal microbiota: Special Diet (exclusion diet, vegetarian diet), taking immunosuppressants (eg calcineurin inhibitors, corticosteroids, biological agents, etc.), taking transit modulators (osmotic or prebiotics such as lactulose).
- Pregnancy or breastfeeding women
- Subject under guardianship or curatorship
- Subject deprived of their liberty by a judicial or administrative decision
- Patient participating to another interventional clinical research (Jardé 1)
- Subject physically unable to give his or her written consent
Trial locations and contacts
1 site in 1 country.
About this study
Bariatric surgery improves health outcomes with a maximal weight loss on average occurring 1 year after surgery but with dramatic between-subjects variability in weight loss (ranging from 20 to 160% excess weight loss) for reasons that remain to be elucidated.
The investigators hypothesize that targeting the 3 months pre-surgery period by a calibrated dietary intervention, with fiber enrichment and biotin, will improve gut microbiota richness and subsequently improve subjects' metabolic health that may optimize post bariatric surgery outcomes.
The study is designed as a pilot, comparative, randomized, open-label trial with 4 arms: standard of care, biotin only, fibers only, biotin + fibers.
Read the detailed description
This is a pilot open label study that aims to examine the efficacy of biotin supplementation with or without enriched soluble and insoluble fibers given during 3 months before the bariatric surgery, on gut microbiota composition and functional capacity to produce B vitamins (primary outcomes), compared to standard of care (e.g. patient preparation to bariatric surgery).
The study is a 4-arm clinical trial:
Arm 1: patients with usual follow-up (standard of care) receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread Arm 2: Same usual general dietary recommendations PLUS Biotin 450 µg per day (1 capsule per day) during 3 months before the surgery.
Arm 3: Same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery Arm 4: Same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber and Biotin 450 µg per day (1 capsule per day), during 3 months before the surgery.
There will be two periods: period 1 during the 3 months before bariatric surgery and period 3 after bariatric surgery (usual standard of care follow-up). The 4 groups will be compared before bariatric surgery and up to 6 months afterward
Patients will receive a schedule of hospitalizations and visits before and after the surgery:
- V0: 3 months before surgery
- V1: presurgery visit, one day hospitalization
- V2: 3 months post-surgery
- V3: 6 months post-surgery
- V4:12 months post-surgery
At each visit (V0, V1, V2 , V3 and V4), will be performed as part of research:
- Adipose tissue aspiration
- Questionnaires
- Fecal samples
- Saliva samples (oral microbiota)
- Blood samples
- Urine samples This planning is part of the standard of care. The same follow-up will be performed in the 4 arms.
Patients will be called 3 times between V0 and V1 by dietician as part of research.
- Conditions
- Severe Obesity, Metabolic Syndrome
- Being tested
- Standard of care, Biotin supplement, Fiber supplement
- Keywords
- GUT microbioTa, Supplementation, Fibers, Biotin, Microbiome, Bariatric surgery
- Medical subject headings
- Obesity, Morbid, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Patients receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread
Biotin supplementDietary supplement
1 capsule per day of Biotin 450µg during 3 months before the surgery.
Fiber supplementDietary supplement
3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: patient with usual follow-up (standard of care) | Active comparator | receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread Receives: Other: Standard of care |
| Arm 2: Same usual general dietary recommendations PLUS Biotin | Experimental | Patients will receive the same usual general dietary recommendations PLUS 1 capsule per day of Biotin 450 µg per day during 3 months before the surgery. Receives: Other: Standard of care; Dietary Supplement: Biotin supplement |
| Arm 3: Same usual general dietary recommendations PLUS Fiber | Experimental | Patients will receive the same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery Receives: Other: Standard of care; Dietary Supplement: Fiber supplement |
| Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin | Experimental | Patients will receive the same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber and Biotin 450 µg per day (1 capsule per day), during 3 months before the surgery. Receives: Other: Standard of care; Dietary Supplement: Biotin supplement; Dietary Supplement: Fiber supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month variation of gut microbiota richness 3 months after the start of the different dietary interventions
Access to gut microbiota richness will be provided after gut microbiota sequencing (by INRAE) with the acquisition of a table comprising the number of genes as well as the record of bacterial genes implicated in synthesis and transport of biotin. Based on preclinical observation, it is expected that the arm 4 combining biotin and fibers will show the highest richness
Measured: At the inclusion and 3 months after supplementation
Secondary outcomes (29)
Assess changes in body weight between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Body Weight will be obtained at each visit between 8 and 10 am using standardized procedures: Body weight will be obtained with a scale (Seca GmbH \& Co., Hamburg, Germany) in kilograms
Measured: At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery
Assess changes in BMI between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Height will be obtained with measuring scale rounded to the nearest 0.5 cm in centimeters Weight and height will be combined to report BMI in kg/m^2
Measured: At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery
Assess changes in waist circumference between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Twaist circumference will be measured in centimeters at the level of the iliac crest and hip circumference at the level of the symphysis-great trochanter to the nearest 1 cm.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in fat mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
For the measurement of fat mass (in kilograms and percentage of body weight), patients will undergo DEXA analysis, using the Hologic Inc. machine, QDR 4500W t using standard software (Hologic Inc., S/N 47168 VER. 11.2)
Measured: At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery
Assess changes in lean mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
For the measurement of lean mass (in kilograms and percentage of body weight), patients will undergo DEXA analysis, using the Hologic Inc. machine, QDR 4500W t using standard software (Hologic Inc., S/N 47168 VER. 11.2)
Measured: At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery
Assess changes in visceral adipose tissue mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
For the measurement of visceral adipose tissue mass (in kilograms and percentage of body weight), patients will undergo DEXA analysis, using the Hologic Inc. machine, QDR 4500W t using standard software (Hologic Inc., S/N 47168 VER. 11.2)
Measured: At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery
Assess changes in blood pressure between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Blood pressure (Systolic and Diastolic) will be measured three times with a mercury sphygmomanometer in the right arm, with patients in a sitting position after five minutes of rest. The average of the three measurements will be considered for analysis
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in insulin resistance markers between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
To predict insulin resistance, homeostatic model assessment of insulin resistance (HOMA-IR) will be calculated according to the following formula: HOMA-IR = [fasting insulin (mU/l) x fasting blood glucose (mmol/l)]/22.5.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in insulin sensitivity markers between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Quantitative insulin sensitivity check index (QUICKI) will be calculated according to the following formula: QUICKI= 1/[log(fasting insulin) + log(fasting blood glucose)
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess change in Leptin between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Leptin (ng/mL) will be measured according to standard protocols using human Leptin ELISA Kit (MyBioSource, Cod. MBS9425103)
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess change in Adiponectin between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Adiponectin (µg/mL) will be measured according to standard protocols using human Adiponectin /Acrp30 Quantikine ELISA kit (DRP300, R\&D Systems)
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in glucose between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
A fasting venous blood draw will be taken from a vein on the forearm to verify blood glucose (g/L) using commercial kits
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in lipid profile between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
A fasting venous blood draw will be taken from a vein on the forearm to verify triglycerides ( g/L), total cholesterol (g/L), HDL- cholesterol(g/L), LDL- cholesterol (g/L), using commercial kits
Measured: At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery
Assess changes in liver function between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
A fasting venous blood draw will be taken from a vein on the forearm to verify alanine aminotransferase (ALT) (UI/L), aspartate aminotransferase (AST) (UI/L), gamma-glutamyl transferase (GGT) (UI/L), using commercial kits
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess change in inflammatory marker (C-reactive protein) between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
C-reactive protein (mg/l) will be measured by multiplex analysis
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in inflammatory markers (IL6, sCD14, IL1b, IL10, TNF-R) between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
IL6, sCD14, IL1b, IL10, TNF-R (pg/mL) will be measured by multiplex analysis
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in adipose tissue gene expression for biotin-dependent carboxylases and inflammatory genes
Adipose tissue aspiration (100 mg): measure for adipose cell size and gene expression study (5-carboxylase depending of biotin and inflammatory markers).
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in quality of life
Information regarding their usual lifestyle by autoquestionnaire: SF-36 (Medical Outcome Study Short Form - 36) ranging from 0 to 100. A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health, an absence of functional deficit and pain
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in emotional eating
Information regarding their usual lifestyle by autoquestionnaire : Dutch Eating Behaviour Questionaire ( DEBQ) : this questionnaire is composed by 33 items divided into 3 scores. Of the original 100 items, 33 will be maintained and divided into 3 scores. Each question allows for 5 possible answers rated from 0 to 5 points. The possible answers are: never (1 point), rarely (2 points), sometimes (3 points), often (4 points), very often (5 points). The scores are as follows:
- Restriction score: 10 questions on the "organised" will to control one's weight.
- Emotionality score: 13 questions divided into two sub-scores, diffuse emotionality for 4 questions and definite emotionality for 9 questions
- Externality score: 10 questions For each score, if the average of the responses is higher than 30, the subject is considered respectively: restricted, emotional eating or external.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in physical activity
Information regarding their usual lifestyle by autoquestionnaire : Recent Physical Activity Questionnaire ( RPAQ) :
- Interpretation of the physical activity (PA) level : Total sum week + weekend :
- <8.3 MET.h/week: inactive ;
- From 8.3 MET.h/week: active, with the possibility of two levels:
- From 8.3 to 16.7: moderate PA;
- >16.7: high PA.
- interpretation of the time spent inactive : For weekdays and weekends:
- ≤7h/d: non-sedentary ;
- >7h/d: sedentary.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in anxiety
Information regarding their usual lifestyle by autoquestionnaire : HAD questionnaire (Hospital Anxiety and Depression questionnaire) : the HAD scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D). (total D), thus allowing two scores to be obtained (maximum score for each score = 21).
For each of the scores (A and D):
- 7 or less: no symptomatology
- 8 to 10: doubtful symptomatology
- 11 and more: definite symptomatology.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in sleep quality
Information regarding their usual lifestyle by autoquestionnaire : STOP band (Snoring - Tired - Observed apnea - Pressure - BMI - Age - Neck size - Gender) questionnaire:
Interpretation of the STOP-BANG:
The STOP-BANG score can be used to identify subjects at risk of sleep apnea (S.A.).
- Low risk of S.A.: Score from 0 to 2.
- Moderate risk of S.A.: Score of 3 to 4.
- High risk of S.A.: Score of 5 to 8, or STOP ≥ 2 and male sex, or STOP ≥ 2 and BMI > 35, or STOP ≥ 2 and neck circumference > 40cm.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in stool consistency
Patients will be asked to answer a Bristol stool scale : the Bristol Scale has seven types of profiles, ranging from constipation (type 1 and 2) to diarrhea (type 6 and 7). Each type corresponds to a specific description of the stool.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in stool inflammatory markers
Fecal calprotectin (in µg/g of feces) will be measured through ELISA kit
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Change in gut microbiota composition by quantitative metagenomics.
Total fecal DNA will be extracted, sequenced by oxford nanopores technology and analysed using momr R package.
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Change in intestinal permeability by Zonuline dosage
Zonuline dosage (ng/mL)
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Change in intestinal permeability by LPS-binding protein dosage
LPS-binding protein dosage (mg/L)
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Systemic measurement of Biotin (B8),B6 and B9-vitamins
Biotin (B8),B6 and B9 (nmol/L) will be measured by Elisa dosage from blood samples
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Systemic measurement of B12-vitamin
B12 (pmol/L) will be measured by Elisa dosage from blood samples
Measured: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start24 Jul 2023
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Why it stopped: end of ERC funding period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832190
- Sponsor's protocol ID
- APHP220972
- Other IDs
- 2022-A02251-42
- Acronym
- GUTERRING
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correcting GUT MicrobioTa by Combined Supplementation of FibERs and BIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes
- ClinicalTrials.gov ID
- NCT05832190
- Acronym / sponsor ID
- GUTERRING / APHP220972
- Conditions
- Severe Obesity, Metabolic Syndrome
- Keywords
- GUT microbioTa, Supplementation, Fibers, Biotin, Microbiome, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of ERC funding period
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 27 Apr 2023 (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.
Bariatric surgery improves health outcomes with a maximal weight loss on average occurring 1 year after surgery but with dramatic between-subjects variability in weight loss (ranging from 20 to 160% excess weight loss) for reasons that remain to be elucidated.
The investigators hypothesize that targeting the 3 months pre-surgery period by a calibrated dietary intervention, with fiber enrichment and biotin, will improve gut microbiota richness and subsequently improve subjects' metabolic health that may optimize post bariatric surgery outcomes.
The study is designed as a pilot, comparative, randomized, open-label trial with 4 arms: standard of care, biotin only, fibers only, biotin + fibers.
Detailed description
This is a pilot open label study that aims to examine the efficacy of biotin supplementation with or without enriched soluble and insoluble fibers given during 3 months before the bariatric surgery, on gut microbiota composition and functional capacity to produce B vitamins (primary outcomes), compared to standard of care (e.g. patient preparation to bariatric surgery).
The study is a 4-arm clinical trial:
Arm 1: patients with usual follow-up (standard of care) receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread Arm 2: Same usual general dietary recommendations PLUS Biotin 450 µg per day (1 capsule per day) during 3 months before the surgery.
Arm 3: Same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery Arm 4: Same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber and Biotin 450 µg per day (1 capsule per day), during 3 months before the surgery.
There will be two periods: period 1 during the 3 months before bariatric surgery and period 3 after bariatric surgery (usual standard of care follow-up). The 4 groups will be compared before bariatric surgery and up to 6 months afterward
Patients will receive a schedule of hospitalizations and visits before and after the surgery:
- V0: 3 months before surgery
- V1: presurgery visit, one day hospitalization
- V2: 3 months post-surgery
- V3: 6 months post-surgery
- V4:12 months post-surgery
At each visit (V0, V1, V2 , V3 and V4), will be performed as part of research:
- Adipose tissue aspiration
- Questionnaires
- Fecal samples
- Saliva samples (oral microbiota)
- Blood samples
- Urine samples This planning is part of the standard of care. The same follow-up will be performed in the 4 arms.
Patients will be called 3 times between V0 and V1 by dietician as part of research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: patient with usual follow-up (standard of care) | Active comparator | Other: Standard of carereceiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread |
| Arm 2: Same usual general dietary recommendations PLUS Biotin | Experimental | Other: Standard of care, Dietary Supplement: Biotin supplementPatients will receive the same usual general dietary recommendations PLUS 1 capsule per day of Biotin 450 µg per day during 3 months before the surgery. |
| Arm 3: Same usual general dietary recommendations PLUS Fiber | Experimental | Other: Standard of care, Dietary Supplement: Fiber supplementPatients will receive the same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery |
| Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin | Experimental | Other: Standard of care, Dietary Supplement: Biotin supplement, Dietary Supplement: Fiber supplementPatients will receive the same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber and Biotin 450 µg per day (1 capsule per day), during 3 months before the surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and < 60 years
- BMI ≥ 40 kg/m² or BMI > 35 kg/m² with at least one comorbidity belonging to metabolic syndrome (hyperglycemia (fasting glycemia > 1g/l, Non diabetic with HbA1C<7% without antidiabetic treatment), dyslipidemia (HDL-cholesterol <0.5 g/l or receiving treatment against dyslipidemia), or increased blood pressure (SBP >13, DBP>9 or treated by antihypertensive drug)), or sleep apnoea, weight stable (less than 3 kg variation in the 2 months before
- Usual Fiber intake < 20g/day in food consumption evaluated by 24h recall
- Signature of the informed consent
- Effective contraception in women of childbearing age
Key exclusion criteria (12 listed)
- Patients receiving antibiotics (ATB) at the selection time or within the 2 previous months.
- (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- Type 1 or type 2 diabetes
- HIV, HBV, HCV
- Gastrointestinal disease: Acute or chronic diarrhea (i.e. more than 3 liquid or fluid stools/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of carePatients receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread | Other | Arm 1: patient with usual follow-up (standard of care), Arm 2: Same usual general dietary recommendations PLUS Biotin, Arm 3: Same usual general dietary recommendations PLUS Fiber, Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin |
| Biotin supplement1 capsule per day of Biotin 450µg during 3 months before the surgery. | Dietary supplement | Arm 2: Same usual general dietary recommendations PLUS Biotin, Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin |
| Fiber supplement3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery | Dietary supplement | Arm 3: Same usual general dietary recommendations PLUS Fiber, Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin |
Primary outcome
3-month variation of gut microbiota richness 3 months after the start of the different dietary interventions
Time frame: At the inclusion and 3 months after supplementation
Access to gut microbiota richness will be provided after gut microbiota sequencing (by INRAE) with the acquisition of a table comprising the number of genes as well as the record of bacterial genes implicated in synthesis and transport of biotin. Based on preclinical observation, it is expected that the arm 4 combining biotin and fibers will show the highest richness
29 secondary outcomes
Assess changes in body weight between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery
Assess changes in BMI between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery
Assess changes in waist circumference between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in fat mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery
Assess changes in lean mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery
Assess changes in visceral adipose tissue mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery
Assess changes in blood pressure between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in insulin resistance markers between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in insulin sensitivity markers between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess change in Leptin between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess change in Adiponectin between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in glucose between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in lipid profile between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery
Assess changes in liver function between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess change in inflammatory marker (C-reactive protein) between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in inflammatory markers (IL6, sCD14, IL1b, IL10, TNF-R) between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in adipose tissue gene expression for biotin-dependent carboxylases and inflammatory genes
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in quality of life
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in emotional eating
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in physical activity
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in anxiety
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in sleep quality
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in stool consistency
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Assess changes in stool inflammatory markers
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Change in gut microbiota composition by quantitative metagenomics.
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Change in intestinal permeability by Zonuline dosage
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Change in intestinal permeability by LPS-binding protein dosage
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Systemic measurement of Biotin (B8),B6 and B9-vitamins
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Systemic measurement of B12-vitamin
Time frame: At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery
Results and safety
The study was stopped early (reason given: end of ERC funding period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biotin supplement and Fiber supplement in people with Severe Obesity and Metabolic Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 6 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: stopped early, as of the sponsor's last update on 15 Jan 2025. 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 was stopped early (reason given: end of ERC funding period). Results are not available in the source record.
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?
3-month variation of gut microbiota richness 3 months after the start of the different dietary interventions (time frame: At the inclusion and 3 months after supplementation). 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 15 Jan 2025.