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Completed

NCT Number: NCT06327919

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

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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Key information

Conditions

Weight Regain After Bariatric Surgery and Food Addiction Behavior Behavior, Addictive Compulsive Behavior Feeding and Eating Disorders Food Addiction Impulsive Behavior Mental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azita Hekmatdoost, Tehran, Middle East, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

placebo supplement

Other

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

Primary outcomes

  1. Weight

    Time frame: 12 weeks

    According to changes in body weight

  2. BMI

    Time frame: 12 weeks

    According to changes in BMI

  3. Waist circumference

    Time frame: 12 weeks

    According to changes in waist circumference

  4. Fat mass

    Time frame: 12 weeks

    According to changes in body fat mass

  5. Food addiction

    Time frame: 12 weeks

    According to changes in Score Of Yale Food Addiction Scale questionnaire

Secondary outcomes

  1. Eating behavior

    Time frame: 12 weeks

    According to changes in Score Of Three-Factor Eating Questionnaire

  2. Leptin

    Time frame: 12 weeks

    According to changes in serum level of leptin

  3. Serotonin

    Time frame: 12 weeks

    According to changes in serum level of serotonin

  4. Oxytocin

    Time frame: 12 weeks

    According to changes in serum level of oxytocin

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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