An interventional study of Probiotic supplement and Placebo supplement in Weight Regain After Bariatric Surgery and Food Addiction, sponsored by National Nutrition and Food Technology Institute. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by National Nutrition and Food Technology Institute · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
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 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
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
The placebo capsule contains 300 mg of starch. 2 capsules per day, for 12 weeks
Weight
According to changes in body weight
Time frame: 12 weeks
BMI
According to changes in BMI
Time frame: 12 weeks
Waist circumference
According to changes in waist circumference
Time frame: 12 weeks
Fat mass
According to changes in body fat mass
Time frame: 12 weeks
Food addiction
According to changes in Score Of Yale Food Addiction Scale questionnaire
Time frame: 12 weeks
Eating behavior
According to changes in Score Of Three-Factor Eating Questionnaire
Time frame: 12 weeks
Leptin
According to changes in serum level of leptin
Time frame: 12 weeks
Serotonin
According to changes in serum level of serotonin
Time frame: 12 weeks
Oxytocin
According to changes in serum level of oxytocin
Time frame: 12 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification will be shared.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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