Obesity
Conditions
Keywords
Very low-calorie diet, Bariatric surgery, Body composition, Gut microbiota pattern
Brief summary
Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. Treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. Bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. Also, it significantly alters gut microbiota composition and function. A very low-calorie diet (VLCD) is a rapid weight loss program which calorie intake is severely restricted (\< 800 kcal/day). It has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. Therefore, this study was aimed to study the effects of 12-week VLCD compare to bariatric surgery (Laparoscopic Roux-en-Y gastric bypass (LRYGB) or Laparoscopic Sleeve Gastrectomy (LSG)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.
Detailed description
The study will include obese patients (body mass index; BMI ≥ 37.5 kg/m2 or BMI ≥ 32.5 kg/m2 with comorbidities), aged 15-65 years at Ramathibodi Hospital, Thailand. The VLCD group will received total diet replacement for 12 weeks and the bariatric surgery group will undergo LRYGB or LSG. Study participants in both groups will be matched according to their age, sex, body mass index (BMI) and diabetic status. Body weight reduction and body composition, gut microbiota pattern, liver stiffness and steatosis, glycemic and other metabolic parameters (glucose, insulin, c-peptide, lipid profile, liver function test, kidney function test, complete blood count, electrolyte blood test, thyroid function tests, serum ketone and adiponectin), health-related quality of life, depression score and twenty-four-hour diet recall and physical activity will be assessed at baseline and at month 1, 3, 6, 9 and 12.
Interventions
Meal replacement (800 kcal/day, protein 90 g/day)
PROCEDUREBariatric surgery
Bariatric surgery will be performed by single surgeon at Ramathibodi Hospital Mahidol University, Thailand. Postoperative diet progression according to the current guideline will be prescribed from early post-op period to 1 year after surgery
Sponsors
Mahidol University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three groups of patients will be recruited at obesity clinic, Ramathibodi Hospital Mahidol University, Bangkok, Thailand. One group will take part in the very low-calorie diet (VLCD). One group will be undergone bariatric surgery (LRYGB or LSG)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 15-65 years * Male or female * Body mass index ≥ 32.5 kg/m2 with obesity related co-morbidity * Body mass index ≥ 37.5 kg/m2 with or without an obesity related co-morbidity
Exclusion criteria
* End stage disease such as cancer, cirrhosis Child-Pugh C, critical/acute illness * Type 1 diabetes mellitus * Recent eGFR \< 30 ml/min/1.73 m2 * Weight loss ≥ 5% in the previous 3 months * Use of antibiotics in the previous 1 month * Use of probiotic or prebiotic supplement in form of tablet or sachet in the previous 14 days * Current treatment with anti-obesity drugs * Pregnancy or breast feeding * Substance abuse * Uncontrolled psychiatric disorder and eating order * History of allergy to any components in meal replacement product or whey protein product * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | From baseline to 12 weeks | Weight in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota pattern | From baseline to 12 weeks | Measured by 16S ribosomal RNA (rRNA) gene sequencing on the fecal samples |
| Liver stiffness | From baseline to 12 weeks | Measured by FibroScan® instrument |
| Liver steatosis | From baseline to 12 weeks | Measured by FibroScan® instrument |
| Blood pressure | From baseline to 12 weeks | Systolic and diastolic blood pressure |
| Fasting plasma glucose | From baseline to 12 weeks | Measured in mg/dl |
| Hemoglobin A1c | From baseline to 12 weeks | Measured in % |
| Fasting insulin | From baseline to 12 weeks | Measured in μIU/l |
| Body Composition | From baseline to 12 weeks | The percentage of body fat and skeleton muscle mass |
| Triglyceride | From baseline to 12 weeks | Measured in mg/dl |
| Total cholesterol | From baseline to 12 weeks | Measured in mg/dl |
| LDL-cholesterol | From baseline to 12 weeks | Measured in mg/dl |
| HDL-cholesterol | From baseline to 12 weeks | Measured in mg/dl |
| Health-related quality of life | From baseline to 12 weeks | Measured by the EQ-5D-5L questionnaire |
| Depression | From baseline to 12 weeks | Measured by the PHQ-9 questionnaire |
| Insulin resistance | From baseline to 12 weeks | Measured by the homeostatic model of insulin resistance (HOMA-IR) |
Countries
Thailand
Outcome results
None listed