Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery

NCT06327919 | Completed DMC

• 1 other identifier: 62885
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups.

Conditions

Weight Regain After Bariatric Surgery and Food Addiction

Outcome Measures

Primary Outcomes (5)

• Weight

  According to changes in body weight

  12 weeks

• BMI

  According to changes in BMI

  12 weeks

• Waist circumference

  According to changes in waist circumference

  12 weeks

• Fat mass

  According to changes in body fat mass

  12 weeks

• Food addiction

  According to changes in Score Of Yale Food Addiction Scale questionnaire

  12 weeks

Secondary Outcomes (4)

• Eating behavior

  12 weeks

• Leptin

  12 weeks

• Serotonin

  12 weeks

• Oxytocin

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Probiotic supplementation with a weight loss program and ten one-hour online individual sessions cognitive behavioral therapy for 12 weeks. multi-strain probiotics were used in this study. Each probiotic capsule contains Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium longum, Lactobacillus reuteri, Lactobacillus rhamnosus, magnesium stearate and maltodextrin. 1.8 × 109 CFU / capsule. 2 capsules per day, for 12 weeks.

Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR

Placebo supplementation with a weight loss program and ten one-hour online individual sessions cognitive behavioral therapy for 12 weeks. The placebo capsule contains 300 mg of starch. 2 capsules per day, for 12 weeks

Other: Placebo supplement

Interventions

Probiotic supplement DIETARY_SUPPLEMENT

multi-strain probiotics were used in this study. Each probiotic capsule contains Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis, Bifidobacterium longum, Lactobacillus reuteri, Lactobacillus rhamnosus, magnesium stearate and maltodextrin. 1.8 × 109 CFU / capsule. 2 capsules per day, for 12 weeks

Intervention

Placebo supplement OTHER

The placebo capsule contains 300 mg of starch. 2 capsules per day, for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥25 kg/m2; willingness to participate in the study; not having diseases such as cancer, thyroid, diabetes, renal or liver (except fatty liver); non-pregnant or lactating or menopause or professional athlete; not use of any antibiotics in the last three weeks and any protein or probiotic supplement in the last month

You may not qualify if:

• taking antibiotic; using probiotic supplements/products or protein supplements; using weight-loss or appetite-suppressing medications; pregnancy; consuming less than 90% of the supplements prescribed during the study; following less than 90% of diet or physical activity for more than 10 days; participants who refuse to continue the study

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (2)

Azita Hekmatdoost

Tehran, Middle East, 19835, Iran

Location

National Nutrition and Food Technology Research Institute

Tehran, Iran

Location

MeSH Terms

Conditions

Food Addiction

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: June 1, 2022
• Primary Completion: May 25, 2023
• Study Completion: September 23, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: beginning 9 months and ending 36 months following article publication.
• Access Criteria: send mail to Atoosa.saidpour@gmail.com.

Locations

IR (2)