Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern

NCT ID: NCT05459675

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2023-07-20

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Very low-calorie diet

Patients in the very low-calorie diet group will be prescribed a very low-calorie diet (meal replacement) for 12 weeks, then the patients will be monitored up to 1 year

Group Type: EXPERIMENTAL

Very low-calorie diet

Intervention Type: OTHER

Meal replacement (800 kcal/day, protein 90 g/day)

Bariatric surgery

Patients in the bariatric surgery group will be undergone bariatric surgery LRYGB and will be follow-up according the current guideline

Group Type: EXPERIMENTAL

Bariatric surgery

Intervention Type: PROCEDURE

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

Interventions

Very low-calorie diet

Meal replacement (800 kcal/day, protein 90 g/day)

Intervention Type: OTHER

Bariatric 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Chanawit Saiyalam

Faculty of Medicine Ramathibodi Hospital Mahidol University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Ramathibodi Hospital Mahidol University

Bangkok, , Thailand

Countries

Thailand

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Other Identifiers

MURA2016/647

Identifier Type: -

Identifier Source: org_study_id