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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-09-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Weight Regain After Bariatric Surgery and Food Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Probiotic supplement

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type OTHER

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No