Weight Regain After Bariatric Surgery and Food Addiction
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic 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
OTHERPlacebo supplement
The placebo capsule contains 300 mg of starch. 2 capsules per day, for 12 weeks
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food addiction | 12 weeks | According to changes in Score Of Yale Food Addiction Scale questionnaire |
| Weight | 12 weeks | According to changes in body weight |
| BMI | 12 weeks | According to changes in BMI |
| Waist circumference | 12 weeks | According to changes in waist circumference |
| Fat mass | 12 weeks | According to changes in body fat mass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leptin | 12 weeks | According to changes in serum level of leptin |
| Serotonin | 12 weeks | According to changes in serum level of serotonin |
| Oxytocin | 12 weeks | According to changes in serum level of oxytocin |
| Eating behavior | 12 weeks | According to changes in Score Of Three-Factor Eating Questionnaire |
Countries
Iran
Outcome results
None listed