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

Sponsor
Mahidol University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05459675
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Very low-calorie diet
  • Procedure: Bariatric surgery
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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)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)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern in Obese Patients
Anticipated Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Nov 20, 2022
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: Very low-calorie diet
Meal replacement (800 kcal/day, protein 90 g/day)
Experimental: Bariatric surgery

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

Procedure: 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

Outcome Measures

Primary Outcome Measures

  1. Changes in body weight [From baseline to 12 weeks]

    Weight in kg

Secondary Outcome Measures

  1. Body Composition [From baseline to 12 weeks]

    The percentage of body fat and skeleton muscle mass

  2. Gut microbiota pattern [From baseline to 12 weeks]

    Measured by 16S ribosomal RNA (rRNA) gene sequencing on the fecal samples

  3. Liver stiffness [From baseline to 12 weeks]

    Measured by FibroScan® instrument

  4. Liver steatosis [From baseline to 12 weeks]

    Measured by FibroScan® instrument

  5. Blood pressure [From baseline to 12 weeks]

    Systolic and diastolic blood pressure

  6. Fasting plasma glucose [From baseline to 12 weeks]

    Measured in mg/dl

  7. Hemoglobin A1c [From baseline to 12 weeks]

    Measured in %

  8. Fasting insulin [From baseline to 12 weeks]

    Measured in μIU/l

  9. Insulin resistance [From baseline to 12 weeks]

    Measured by the homeostatic model of insulin resistance (HOMA-IR)

  10. Triglyceride [From baseline to 12 weeks]

    Measured in mg/dl

  11. Total cholesterol [From baseline to 12 weeks]

    Measured in mg/dl

  12. LDL-cholesterol [From baseline to 12 weeks]

    Measured in mg/dl

  13. HDL-cholesterol [From baseline to 12 weeks]

    Measured in mg/dl

  14. Health-related quality of life [From baseline to 12 weeks]

    Measured by the EQ-5D-5L questionnaire

  15. Depression [From baseline to 12 weeks]

    Measured by the PHQ-9 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok Thailand 10400

Sponsors and Collaborators

  • Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chanawit Saiyalam, Faculty of Medicine Ramathibodi Hospital Mahidol University, Mahidol University
ClinicalTrials.gov Identifier:
NCT05459675
Other Study ID Numbers:
  • MURA2016/647
First Posted:
Jul 15, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chanawit Saiyalam, Faculty of Medicine Ramathibodi Hospital Mahidol University, Mahidol University
Very low-calorie diet
Bariatric surgery
Body composition
Gut microbiota pattern

Study Results

No Results Posted as of Jul 15, 2022