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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05459675
• Other study ID #: MURA2016/647
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: July 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 54
• Est. completion date: July 20, 2023
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8. — View Citation

Castaner O, Goday A, Park YM, Lee SH, Magkos F, Shiow STE, Schroder H. The Gut Microbiome Profile in Obesity: A Systematic Review. Int J Endocrinol. 2018 Mar 22;2018:4095789. doi: 10.1155/2018/4095789. eCollection 2018. — View Citation

Damms-Machado A, Mitra S, Schollenberger AE, Kramer KM, Meile T, Konigsrainer A, Huson DH, Bischoff SC. Effects of surgical and dietary weight loss therapy for obesity on gut microbiota composition and nutrient absorption. Biomed Res Int. 2015;2015:806248. doi: 10.1155/2015/806248. Epub 2015 Feb 1. — View Citation

Guo Y, Huang ZP, Liu CQ, Qi L, Sheng Y, Zou DJ. Modulation of the gut microbiome: a systematic review of the effect of bariatric surgery. Eur J Endocrinol. 2018 Jan;178(1):43-56. doi: 10.1530/EJE-17-0403. Epub 2017 Sep 15. — View Citation

Lane M, Howland G, West M, Hockey M, Marx W, Loughman A, O'Hely M, Jacka F, Rocks T. The effect of ultra-processed very low-energy diets on gut microbiota and metabolic outcomes in individuals with obesity: A systematic literature review. Obes Res Clin Pract. 2020 May-Jun;14(3):197-204. doi: 10.1016/j.orcp.2020.04.006. Epub 2020 Jun 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wharton S, Lau DCW, Vallis M, Sharma AM, Biertho L, Campbell-Scherer D, Adamo K, Alberga A, Bell R, Boule N, Boyling E, Brown J, Calam B, Clarke C, Crowshoe L, Divalentino D, Forhan M, Freedhoff Y, Gagner M, Glazer S, Grand C, Green M, Hahn M, Hawa R, Henderson R, Hong D, Hung P, Janssen I, Jacklin K, Johnson-Stoklossa C, Kemp A, Kirk S, Kuk J, Langlois MF, Lear S, McInnes A, Macklin D, Naji L, Manjoo P, Morin MP, Nerenberg K, Patton I, Pedersen S, Pereira L, Piccinini-Vallis H, Poddar M, Poirier P, Prud'homme D, Salas XR, Rueda-Clausen C, Russell-Mayhew S, Shiau J, Sherifali D, Sievenpiper J, Sockalingam S, Taylor V, Toth E, Twells L, Tytus R, Walji S, Walker L, Wicklum S. Obesity in adults: a clinical practice guideline. CMAJ. 2020 Aug 4;192(31):E875-E891. doi: 10.1503/cmaj.191707. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight	Weight in kg	From baseline to 12 weeks
Secondary	Body Composition	The percentage of body fat and skeleton muscle mass	From baseline to 12 weeks
Secondary	Gut microbiota pattern	Measured by 16S ribosomal RNA (rRNA) gene sequencing on the fecal samples	From baseline to 12 weeks
Secondary	Liver stiffness	Measured by FibroScan® instrument	From baseline to 12 weeks
Secondary	Liver steatosis	Measured by FibroScan® instrument	From baseline to 12 weeks
Secondary	Blood pressure	Systolic and diastolic blood pressure	From baseline to 12 weeks
Secondary	Fasting plasma glucose	Measured in mg/dl	From baseline to 12 weeks
Secondary	Hemoglobin A1c	Measured in %	From baseline to 12 weeks
Secondary	Fasting insulin	Measured in µIU/l	From baseline to 12 weeks
Secondary	Insulin resistance	Measured by the homeostatic model of insulin resistance (HOMA-IR)	From baseline to 12 weeks
Secondary	Triglyceride	Measured in mg/dl	From baseline to 12 weeks
Secondary	Total cholesterol	Measured in mg/dl	From baseline to 12 weeks
Secondary	LDL-cholesterol	Measured in mg/dl	From baseline to 12 weeks
Secondary	HDL-cholesterol	Measured in mg/dl	From baseline to 12 weeks
Secondary	Health-related quality of life	Measured by the EQ-5D-5L questionnaire	From baseline to 12 weeks
Secondary	Depression	Measured by the PHQ-9 questionnaire	From baseline to 12 weeks