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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azita Hekmatdoost | Tehran | Middle East | 19835 | Iran | ||
| National Nutrition and Food Technology Research Institute |
Individual participant data that underlie the results reported in this article, after deidentification will be shared.
beginning 9 months and ending 36 months following article publication.
send mail to Atoosa.saidpour@gmail.com.
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|
| Placebo supplement | Other | The placebo capsule contains 300 mg of starch. 2 capsules per day, for 12 weeks |
|
| 12 weeks |
| Serotonin | According to changes in serum level of serotonin | 12 weeks |
| Oxytocin | According to changes in serum level of oxytocin | 12 weeks |
| Tehran |
| Iran |
| ID | Term |
|---|---|
| D000073932 | Food Addiction |
| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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