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

Not Applicable

Completed

• Conditions: Weight Regain After Bariatric Surgery and Food Addiction
• Interventions: Dietary Supplement: Probiotic supplement; Other: Placebo supplement

• Registration Number: NCT06327919
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2023-05-25
• Study Completion: 2023-09-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Last Update Submitted: 2024-03-18
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Probiotic supplement	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.
Placebo	Placebo supplement	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

Primary Outcome Measures

Name	Time	Method
Weight	12 weeks	According to changes in body weight
Waist circumference	12 weeks	According to changes in waist circumference
Fat mass	12 weeks	According to changes in body fat mass
Food addiction	12 weeks	According to changes in Score Of Yale Food Addiction Scale questionnaire
BMI	12 weeks	According to changes in BMI

Secondary Outcome Measures

Name	Time	Method
Oxytocin	12 weeks	According to changes in serum level of oxytocin
Eating behavior	12 weeks	According to changes in Score Of Three-Factor Eating Questionnaire
Serotonin	12 weeks	According to changes in serum level of serotonin
Leptin	12 weeks	According to changes in serum level of leptin

Trial Locations

Locations (2)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of

Azita Hekmatdoost; 🇮🇷 Tehran, Middle East, Iran, Islamic Republic of