ObesityNCT05459675
Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern
A study testing Very low-calorie diet and Bariatric surgery in people with Obesity, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Very low-calorie diet and Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jul 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Ramathibodi Hospital Mahidol University
Bangkok, 10400
About this study
Official title: Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern in Obese Patients
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.
Read the 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
- Being tested
- Very low-calorie diet, Bariatric surgery
- Keywords
- Very low-calorie diet, Bariatric surgery, Body composition, Gut microbiota pattern
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low-calorie dietOther
Meal replacement (800 kcal/day, protein 90 g/day)
Bariatric surgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Weight in kg
Measured: From baseline to 12 weeks
Secondary outcomes (15)
Body Composition
The percentage of body fat and skeleton muscle mass
Measured: From baseline to 12 weeks
Gut microbiota pattern
Measured by 16S ribosomal RNA (rRNA) gene sequencing on the fecal samples
Measured: From baseline to 12 weeks
Liver stiffness
Measured by FibroScan® instrument
Measured: From baseline to 12 weeks
Liver steatosis
Measured by FibroScan® instrument
Measured: From baseline to 12 weeks
Blood pressure
Systolic and diastolic blood pressure
Measured: From baseline to 12 weeks
Fasting plasma glucose
Measured in mg/dl
Measured: From baseline to 12 weeks
Hemoglobin A1c
Measured in %
Measured: From baseline to 12 weeks
Fasting insulin
Measured in μIU/l
Measured: From baseline to 12 weeks
Insulin resistance
Measured by the homeostatic model of insulin resistance (HOMA-IR)
Measured: From baseline to 12 weeks
Triglyceride
Measured in mg/dl
Measured: From baseline to 12 weeks
Total cholesterol
Measured in mg/dl
Measured: From baseline to 12 weeks
LDL-cholesterol
Measured in mg/dl
Measured: From baseline to 12 weeks
HDL-cholesterol
Measured in mg/dl
Measured: From baseline to 12 weeks
Health-related quality of life
Measured by the EQ-5D-5L questionnaire
Measured: From baseline to 12 weeks
Depression
Measured by the PHQ-9 questionnaire
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start20 Jul 2022
- Primary completion20 Nov 2022
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chanawit Saiyalam, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459675
- Sponsor's protocol ID
- MURA2016/647
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32753461Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
PubMed 30814686Scheithauer 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.
PubMed 33178196Shao 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.
PubMed 27440168Lean 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.
PubMed 29221645Umphonsathien 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.
PubMed 30918654Lane 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.
PubMed 32546361Guo 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.
PubMed 28916564Damms-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.
PubMed 25710027Castaner 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.
PubMed 29849617
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low-calorie Diet Versus Bariatric Surgery on Body Composition and Gut Microbiota Pattern in Obese Patients
- ClinicalTrials.gov ID
- NCT05459675
- Acronym / sponsor ID
- MURA2016/647
- Conditions
- Obesity
- Keywords
- Very low-calorie diet, Bariatric surgery, Body composition, Gut microbiota pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Very low-calorie diet | Experimental | Other: Very low-calorie dietPatients 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 |
| Bariatric surgery | Experimental | Procedure: Bariatric surgeryPatients in the bariatric surgery group will be undergone bariatric surgery LRYGB and will be follow-up according the current guideline |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low-calorie dietMeal replacement (800 kcal/day, protein 90 g/day) | Other | Very low-calorie diet |
| Bariatric surgeryBariatric 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 | Procedure or surgery | Bariatric surgery |
Primary outcome
Changes in body weight
Time frame: From baseline to 12 weeks
Weight in kg
15 secondary outcomes
Body Composition
Time frame: From baseline to 12 weeks
Gut microbiota pattern
Time frame: From baseline to 12 weeks
Liver stiffness
Time frame: From baseline to 12 weeks
Liver steatosis
Time frame: From baseline to 12 weeks
Blood pressure
Time frame: From baseline to 12 weeks
Fasting plasma glucose
Time frame: From baseline to 12 weeks
Hemoglobin A1c
Time frame: From baseline to 12 weeks
Fasting insulin
Time frame: From baseline to 12 weeks
Insulin resistance
Time frame: From baseline to 12 weeks
Triglyceride
Time frame: From baseline to 12 weeks
Total cholesterol
Time frame: From baseline to 12 weeks
LDL-cholesterol
Time frame: From baseline to 12 weeks
HDL-cholesterol
Time frame: From baseline to 12 weeks
Health-related quality of life
Time frame: From baseline to 12 weeks
Depression
Time frame: From baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: PubMed 32753461Wharton 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.
- Background: PubMed 30814686Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
- Background: PubMed 33178196Scheithauer 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.
- Background: PubMed 27440168Shao 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.
- Background: PubMed 29221645Lean 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.
- Background: PubMed 30918654Umphonsathien 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.
- Background: PubMed 32546361Lane 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.
- Background: PubMed 28916564Guo 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.
- Background: PubMed 25710027Damms-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.
- Background: PubMed 29849617Castaner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low-calorie diet and Bariatric surgery in people with Obesity, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: From baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459675, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.