Correcting GUT MicrobioTa by Combined Supplementation of FibERs and BIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes

NCT05832190 | Terminated

• 2 other identifiers: APHP2209722022-A02251-42
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Severe Obesity; Metabolic Syndrome

Keywords

GUT microbioTa; Supplementation; Fibers; Biotin; Microbiome; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

  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

  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

  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

  At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery

Study Arms (4)

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

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.

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

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.

Other: Standard of care; Dietary Supplement: Biotin supplement; Dietary Supplement: Fiber supplement

Interventions

Standard of care OTHER

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

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 supplement DIETARY_SUPPLEMENT

1 capsule per day of Biotin 450µg during 3 months before the surgery.

Arm 2: Same usual general dietary recommendations PLUS Biotin; Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin

Fiber supplement DIETARY_SUPPLEMENT

3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery

Arm 3: Same usual general dietary recommendations PLUS Fiber; Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS Biotin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

hôpital Pitié Salpêtrière

Paris, France, 75013, France

Location

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: April 27, 2023
• Study Start: July 24, 2023
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)