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

Effects of Probiotic Supplementation With Weight Reducing Plan on Anthropometric Measures, Body Composition, Eating Behavior, and Related Hormone Levels in Patients With Food Addiction and Weight Regain After Bariatric Surgery: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Weight Regain After Bariatric Surgery and Food Addiction
• Intervention / Treatment: Dietary supplement: Probiotic supplement; Other: Placebo supplement

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • National Nutrition and Food Technology Research Institute
  • Middle East
    • Tehran, Middle East, Iran, Islamic Republic of, 19835
      • Azita Hekmatdoost

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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 Comparator: Placebo; 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; The placebo capsule contains 300 mg of starch. 2 capsules per day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): September 23, 2023

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Compulsive Behavior; Impulsive Behavior; Body Weight; Behavior, Addictive; Food Addiction
• Other Study ID Numbers: 62885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification will be shared.
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: send mail to Atoosa.saidpour@gmail.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No