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

NCT05459675 | Unknown

• 1 other identifier: MURA2016/647
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Very low-calorie diet; Bariatric surgery; Body composition; Gut microbiota pattern

Outcome Measures

Primary Outcomes (1)

• Changes in body weight

  Weight in kg

  From baseline to 12 weeks

Secondary Outcomes (15)

• Body Composition

  From baseline to 12 weeks

• Gut microbiota pattern

  From baseline to 12 weeks

• Liver stiffness

  From baseline to 12 weeks

• Liver steatosis

  From baseline to 12 weeks

• Blood pressure

  From baseline to 12 weeks

Study Arms (2)

Very low-calorie diet

EXPERIMENTAL

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

Bariatric surgery

EXPERIMENTAL

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

Procedure: Bariatric surgery

Interventions

Very low-calorie diet OTHER

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

Very low-calorie diet

Bariatric surgery 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

Bariatric surgery

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (10)

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  PMID: 32753461 BACKGROUND

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  PMID: 30814686 BACKGROUND

• Scheithauer TPM, Rampanelli E, Nieuwdorp M, Vallance BA, Verchere CB, van Raalte DH, Herrema H. Gut Microbiota as a Trigger for Metabolic Inflammation in Obesity and Type 2 Diabetes. Front Immunol. 2020 Oct 16;11:571731. doi: 10.3389/fimmu.2020.571731. eCollection 2020.

  PMID: 33178196 BACKGROUND

• Shao Y, Ding R, Xu B, Hua R, Shen Q, He K, Yao Q. Alterations of Gut Microbiota After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy in Sprague-Dawley Rats. Obes Surg. 2017 Feb;27(2):295-302. doi: 10.1007/s11695-016-2297-7.

  PMID: 27440168 BACKGROUND

• Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

  PMID: 29221645 BACKGROUND

• Umphonsathien M, Prutanopajai P, Aiam-O-Ran J, Thararoop T, Karin A, Kanjanapha C, Jiamjarasrangsi W, Khovidhunkit W. Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. Food Sci Nutr. 2019 Feb 11;7(3):1113-1122. doi: 10.1002/fsn3.956. eCollection 2019 Mar.

  PMID: 30918654 BACKGROUND

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  PMID: 32546361 BACKGROUND

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  PMID: 28916564 BACKGROUND

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  PMID: 25710027 BACKGROUND

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  PMID: 29849617 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine Ramathibodi Hospital Mahidol University

Model Details: 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)

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 15, 2022
• Study Start: July 20, 2022
• Primary Completion: November 20, 2022
• Study Completion: July 20, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)