Body WeightNCT05869799
Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants
A study testing Vigiis 101 Lactobacillus Capsules in people with Body Weight and Body Fat, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.
Trial summary
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up) Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Body Fat, Overweight
- What is being tested?
- Vigiis 101 Lactobacillus Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 30 Apr 2025
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are 20-65-year-old men or non-pregnant women (women of childbearing age are not allowed to become pregnant or breastfeed during the study) and adult volunteers who are conscious and able to communicate.
- Subjects with a body mass index (BMI) between 23 and 29.9 (kg/m2 ) and classified as overweight according to the World Health Organization Asia-Pacific criteria.
- Subjects who agree to participate in this trial and voluntarily agree to the test consent in writing.
Who cannot join
- Subjects who are pregnant or lactating or expecting pregnancy.
- Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery.
- Subjects suffering from high blood pressure (≥160/100 mmHg, after resting for 10 minutes) or taking diuretics.
- Subjects with diabetes (fasting blood glucose (≥125 mg/dL).
- Suffering from heart disease, liver and kidney insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumor or any other diseases that affect the research results.
- Suffering from depression, schizophrenia, alcoholism, drug addiction and other mental disorders or taking drugs (such as psychotropic drugs, β receptor blockers).
Show all 16Show fewer
- Subjects have taken drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional foods within 2 weeks before the screening visit.
- Subjects judged to be unable to exercise due to severe musculoskeletal diseases.
- Subjects who consumed probiotics or expected to consume probiotics within 2 weeks before the screening visit.
- Subjects who have participated in or are expected to participate in clinical trials within 4 weeks before the screening visit.
- The withdrawal criteria are as follows:
- Unable to take the test sample on time (i.e. more than 7 days out of every 4 weeks without taking the sample) (2) Unable to cooperate with the return visit on time (after being contacted or lost contact, 7 days beyond the expected return visit time) (2) If the subject chooses to voluntarily stop participating due to personal reasons.
- Serious violations of the research protocol. (4) Taking drugs that may affect body weight or body fat (such as contraceptives, steroids, female hormones) or functional health food with probiotics in the experiment.
- When severe adverse reactions occur clinically. (6) The aforementioned "subject exclusion conditions" did not occur during the screening period, and must be withdrawn if they occur during the trial.
- Other situations where continuing to participate in the research will endanger the health of the subject. When there is important new information during the execution of the trial (referring to your rights or affecting your willingness to continue participating), you will be notified and further explained. Please reconsider whether to continue participating. You can decide freely and will not cause any discomfort. Or affect their future physicians to your medical care.
- The project host or the sponsor may also suspend the entire experiment if necessary.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital, National Defense Medical Center
Taipei, 114202
WEN-HUI FANG, Ph. D., +886 2 87923311, rumaf.fang@gmail.com
About this study
Official title: Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants: a Randomized, Double-blinded, Placebo-controlled Trial
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
Read the detailed description
Subjects meeting the inclusion criteria were randomly assigned to 2 groups (Vigiis 101 lactic acid bacteria: n = 50, placebo: n = 50) in a 1:1 ratio, Block : 4 randomization. Randomization was performed by a research statistician not directly involved in the trial. Researchers and subjects were unaware of treatment groups until data analysis was complete.
During the 12-week use trial, subjects were asked to take Vigiis 101 Lactobacillus capsules or a placebo once a day before breakfast. The subjects were required to maintain a regular lifestyle and recorded daily Vigiis 101 Lactobacillus or placebo consumption, diet and the number of steps walked as a measure of physical activity. Body composition, anthropometric and biochemical measurements were measured at weeks 0, 4, 8, and 12 after consumption initiation. Clinical exams are done every 4 weeks in the hospital. Subjects filled out daily diaries that included questions about study product intake, other food intake, number of bowel movements, stool quality (consistency and color), any medications received, and any uncomfortable symptoms such as diarrhea, constipation, Vomiting, flatulence, discomfort, etc.
- Conditions
- Body Weight, Body Fat, Overweight
- Being tested
- Vigiis 101 Lactobacillus Capsules, Placebo Capsules
- Medical subject headings
- Body Weight, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigiis 101 Lactobacillus CapsulesDietary supplement
Product ingredients: microcrystalline cellulose, corn starch, NTU 101 lactic acid bacteria powder (1.0 x 10^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum.
Placebo CapsulesDietary supplement
Maltodextrin was used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Vigiis 101 Lactobacillus Capsules | Experimental | Vigiis 101 Lactic Acid Bacteria Capsules is a commercially available product for Lactobacillus paracasei subspecies paracasei NTU 101 (NTU 101) is a strain of Lactobacillus isolated from the intestinal tract of newborns in Taiwan. 10 billion CFU/cap of NTU 101 freeze-dried powder (production research and development: Chenhui Biotechnology Co., Ltd. Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in vegetable capsules were prepared. Receives: Dietary Supplement: Vigiis 101 Lactobacillus Capsules |
| Placebo Capsules | Placebo comparator | Maltodextrin was used as a placebo. Receives: Dietary Supplement: Placebo Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI improvement
Improvement in BMI from baseline was used as the primary outcome.
Measured: 12 weeks
Secondary outcomes (1)
Other body index improvements
The secondary outcome was the improvement in body fat percentage (measured in %).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SunWay Biotech Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- WEN-HUI FANG, Ph. D., Principal investigator, Chief of Family medicine department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869799
- Sponsor's protocol ID
- 24 Vigiis 101
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breton J, Galmiche M, Dechelotte P. Dysbiotic Gut Bacteria in Obesity: An Overview of the Metabolic Mechanisms and Therapeutic Perspectives of Next-Generation Probiotics. Microorganisms. 2022 Feb 16;10(2):452. doi: 10.3390/microorganisms10020452.
PubMed 35208906Chiang SS, Pan TM. Antiosteoporotic effects of Lactobacillus -fermented soy skim milk on bone mineral density and the microstructure of femoral bone in ovariectomized mice. J Agric Food Chem. 2011 Jul 27;59(14):7734-42. doi: 10.1021/jf2013716. Epub 2011 Jun 21.
PubMed 21668014Chiu CH, Lu TY, Tseng YY, Pan TM. The effects of Lactobacillus-fermented milk on lipid metabolism in hamsters fed on high-cholesterol diet. Appl Microbiol Biotechnol. 2006 Jun;71(2):238-45. doi: 10.1007/s00253-005-0145-0. Epub 2005 Sep 20.
PubMed 16172889Cheng MC, Tsai TY, Pan TM. Anti-obesity activity of the water extract of Lactobacillus paracasei subsp. paracasei NTU 101 fermented soy milk products. Food Funct. 2015 Nov;6(11):3522-30. doi: 10.1039/c5fo00531k. Epub 2015 Aug 24.
PubMed 26299532Leon Aguilera XE, Manzano A, Pirela D, Bermudez V. Probiotics and Gut Microbiota in Obesity: Myths and Realities of a New Health Revolution. J Pers Med. 2022 Aug 4;12(8):1282. doi: 10.3390/jpm12081282.
PubMed 36013231Liu CF, Tung YT, Wu CL, Lee BH, Hsu WH, Pan TM. Antihypertensive effects of Lactobacillus-fermented milk orally administered to spontaneously hypertensive rats. J Agric Food Chem. 2011 May 11;59(9):4537-43. doi: 10.1021/jf104985v. Epub 2011 Apr 4.
PubMed 21446645Liu TH, Tsai TY, Pan TM. The Anti-Periodontitis Effects of Ethanol Extract Prepared Using Lactobacillus paracasei subsp. paracasei NTU 101. Nutrients. 2018 Apr 12;10(4):472. doi: 10.3390/nu10040472.
PubMed 29649103Musazadeh V, Zarezadeh M, Ghalichi F, Ahrabi SS, Jamilian P, Jamilian P, Ghoreishi Z. Anti-obesity properties of probiotics; a considerable medical nutrition intervention: Findings from an umbrella meta-analysis. Eur J Pharmacol. 2022 Aug 5;928:175069. doi: 10.1016/j.ejphar.2022.175069. Epub 2022 Jun 1.
PubMed 35659967Nam GE, Kim YH, Han K, Jung JH, Rhee EJ, Lee WY; Obesity Fact Sheet of the Korean Society for the Study of Obesity. Obesity Fact Sheet in Korea, 2020: Prevalence of Obesity by Obesity Class from 2009 to 2018. J Obes Metab Syndr. 2021 Jun 30;30(2):141-148. doi: 10.7570/jomes21056.
PubMed 34158420Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.
PubMed 24009397Tsai TY, Chu LH, Lee CL, Pan TM. Atherosclerosis-preventing activity of lactic acid bacteria-fermented milk-soymilk supplemented with Momordica charantia. J Agric Food Chem. 2009 Mar 11;57(5):2065-71. doi: 10.1021/jf802936c.
PubMed 19216552Tsai YT, Cheng PC, Pan TM. Immunomodulating activity of Lactobacillus paracasei subsp. paracasei NTU 101 in enterohemorrhagic Escherichia coli O157H7-infected mice. J Agric Food Chem. 2010 Nov 10;58(21):11265-72. doi: 10.1021/jf103011z. Epub 2010 Oct 13.
PubMed 20942489Tsai YT, Cheng PC, Fan CK, Pan TM. Time-dependent persistence of enhanced immune response by a potential probiotic strain Lactobacillus paracasei subsp. paracasei NTU 101. Int J Food Microbiol. 2008 Dec 10;128(2):219-25. doi: 10.1016/j.ijfoodmicro.2008.08.009. Epub 2008 Aug 26.
PubMed 18809220Vallianou N, Dalamaga M, Stratigou T, Karampela I, Tsigalou C. Do Antibiotics Cause Obesity Through Long-term Alterations in the Gut Microbiome? A Review of Current Evidence. Curr Obes Rep. 2021 Sep;10(3):244-262. doi: 10.1007/s13679-021-00438-w. Epub 2021 May 4.
PubMed 33945146
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants: a Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05869799
- Acronym / sponsor ID
- 24 Vigiis 101
- Conditions
- Body Weight, Body Fat, Overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SunWay Biotech Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 22 May 2023 (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.
This study is a randomized, double-blind, placebo-controlled, parallel-controlled trial (14 weeks in total), divided into three periods (screening, treatment, and discontinuation follow-up)
Detailed description
Subjects meeting the inclusion criteria were randomly assigned to 2 groups (Vigiis 101 lactic acid bacteria: n = 50, placebo: n = 50) in a 1:1 ratio, Block : 4 randomization. Randomization was performed by a research statistician not directly involved in the trial. Researchers and subjects were unaware of treatment groups until data analysis was complete.
During the 12-week use trial, subjects were asked to take Vigiis 101 Lactobacillus capsules or a placebo once a day before breakfast. The subjects were required to maintain a regular lifestyle and recorded daily Vigiis 101 Lactobacillus or placebo consumption, diet and the number of steps walked as a measure of physical activity. Body composition, anthropometric and biochemical measurements were measured at weeks 0, 4, 8, and 12 after consumption initiation. Clinical exams are done every 4 weeks in the hospital. Subjects filled out daily diaries that included questions about study product intake, other food intake, number of bowel movements, stool quality (consistency and color), any medications received, and any uncomfortable symptoms such as diarrhea, constipation, Vomiting, flatulence, discomfort, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vigiis 101 Lactobacillus Capsules | Experimental | Dietary Supplement: Vigiis 101 Lactobacillus CapsulesVigiis 101 Lactic Acid Bacteria Capsules is a commercially available product for Lactobacillus paracasei subspecies paracasei NTU 101 (NTU 101) is a strain of Lactobacillus isolated from the intestinal tract of newborns in Taiwan. 10 billion CFU/cap of NTU 101 freeze-dried powder (production research and development: Chenhui Biotechnology Co., Ltd. Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in vegetable capsules were prepared. |
| Placebo Capsules | Placebo comparator | Dietary Supplement: Placebo CapsulesMaltodextrin was used as a placebo. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects are 20-65-year-old men or non-pregnant women (women of childbearing age are not allowed to become pregnant or breastfeed during the study) and adult volunteers who are conscious and able to communicate.
- Subjects with a body mass index (BMI) between 23 and 29.9 (kg/m2 ) and classified as overweight according to the World Health Organization Asia-Pacific criteria.
- Subjects who agree to participate in this trial and voluntarily agree to the test consent in writing.
Key exclusion criteria (16 listed)
- Subjects who are pregnant or lactating or expecting pregnancy.
- Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery.
- Subjects suffering from high blood pressure (≥160/100 mmHg, after resting for 10 minutes) or taking diuretics.
- Subjects with diabetes (fasting blood glucose (≥125 mg/dL).
- Suffering from heart disease, liver and kidney insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumor or any other diseases that affect the research results.
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 |
|---|---|---|
| Vigiis 101 Lactobacillus CapsulesProduct ingredients: microcrystalline cellulose, corn starch, NTU 101 lactic acid bacteria powder (1.0 x 10^10 CFU); capsule shell composition: HPMC (hydroxypropyl methylcellulose), purified water, titanium dioxide, gellan gum. | Dietary supplement | Vigiis 101 Lactobacillus Capsules |
| Placebo CapsulesMaltodextrin was used as a placebo | Dietary supplement | Placebo Capsules |
Primary outcome
BMI improvement
Time frame: 12 weeks
Improvement in BMI from baseline was used as the primary outcome.
1 secondary outcome
Other body index improvements
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Results publication: PubMed 35208906Breton J, Galmiche M, Dechelotte P. Dysbiotic Gut Bacteria in Obesity: An Overview of the Metabolic Mechanisms and Therapeutic Perspectives of Next-Generation Probiotics. Microorganisms. 2022 Feb 16;10(2):452. doi: 10.3390/microorganisms10020452.
- Results publication: PubMed 21668014Chiang SS, Pan TM. Antiosteoporotic effects of Lactobacillus -fermented soy skim milk on bone mineral density and the microstructure of femoral bone in ovariectomized mice. J Agric Food Chem. 2011 Jul 27;59(14):7734-42. doi: 10.1021/jf2013716. Epub 2011 Jun 21.
- Results publication: PubMed 16172889Chiu CH, Lu TY, Tseng YY, Pan TM. The effects of Lactobacillus-fermented milk on lipid metabolism in hamsters fed on high-cholesterol diet. Appl Microbiol Biotechnol. 2006 Jun;71(2):238-45. doi: 10.1007/s00253-005-0145-0. Epub 2005 Sep 20.
- Results publication: PubMed 26299532Cheng MC, Tsai TY, Pan TM. Anti-obesity activity of the water extract of Lactobacillus paracasei subsp. paracasei NTU 101 fermented soy milk products. Food Funct. 2015 Nov;6(11):3522-30. doi: 10.1039/c5fo00531k. Epub 2015 Aug 24.
- Results publication: PubMed 36013231Leon Aguilera XE, Manzano A, Pirela D, Bermudez V. Probiotics and Gut Microbiota in Obesity: Myths and Realities of a New Health Revolution. J Pers Med. 2022 Aug 4;12(8):1282. doi: 10.3390/jpm12081282.
- Results publication: PubMed 21446645Liu CF, Tung YT, Wu CL, Lee BH, Hsu WH, Pan TM. Antihypertensive effects of Lactobacillus-fermented milk orally administered to spontaneously hypertensive rats. J Agric Food Chem. 2011 May 11;59(9):4537-43. doi: 10.1021/jf104985v. Epub 2011 Apr 4.
- Results publication: PubMed 29649103Liu TH, Tsai TY, Pan TM. The Anti-Periodontitis Effects of Ethanol Extract Prepared Using Lactobacillus paracasei subsp. paracasei NTU 101. Nutrients. 2018 Apr 12;10(4):472. doi: 10.3390/nu10040472.
- Results publication: PubMed 35659967Musazadeh V, Zarezadeh M, Ghalichi F, Ahrabi SS, Jamilian P, Jamilian P, Ghoreishi Z. Anti-obesity properties of probiotics; a considerable medical nutrition intervention: Findings from an umbrella meta-analysis. Eur J Pharmacol. 2022 Aug 5;928:175069. doi: 10.1016/j.ejphar.2022.175069. Epub 2022 Jun 1.
- Results publication: PubMed 34158420Nam GE, Kim YH, Han K, Jung JH, Rhee EJ, Lee WY; Obesity Fact Sheet of the Korean Society for the Study of Obesity. Obesity Fact Sheet in Korea, 2020: Prevalence of Obesity by Obesity Class from 2009 to 2018. J Obes Metab Syndr. 2021 Jun 30;30(2):141-148. doi: 10.7570/jomes21056.
- Results publication: PubMed 24009397Ridaura VK, Faith JJ, Rey FE, Cheng J, Duncan AE, Kau AL, Griffin NW, Lombard V, Henrissat B, Bain JR, Muehlbauer MJ, Ilkayeva O, Semenkovich CF, Funai K, Hayashi DK, Lyle BJ, Martini MC, Ursell LK, Clemente JC, Van Treuren W, Walters WA, Knight R, Newgard CB, Heath AC, Gordon JI. Gut microbiota from twins discordant for obesity modulate metabolism in mice. Science. 2013 Sep 6;341(6150):1241214. doi: 10.1126/science.1241214.
- Results publication: PubMed 19216552Tsai TY, Chu LH, Lee CL, Pan TM. Atherosclerosis-preventing activity of lactic acid bacteria-fermented milk-soymilk supplemented with Momordica charantia. J Agric Food Chem. 2009 Mar 11;57(5):2065-71. doi: 10.1021/jf802936c.
- Results publication: PubMed 20942489Tsai YT, Cheng PC, Pan TM. Immunomodulating activity of Lactobacillus paracasei subsp. paracasei NTU 101 in enterohemorrhagic Escherichia coli O157H7-infected mice. J Agric Food Chem. 2010 Nov 10;58(21):11265-72. doi: 10.1021/jf103011z. Epub 2010 Oct 13.
- 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.
WEN-HUI FANG, Ph. D. principal investigator
Chief of Family medicine department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigiis 101 Lactobacillus Capsules in people with Body Weight and Body Fat, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.
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 3 inclusion and 16 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 20 Dec 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Sean Lin (02-27929568 ext. 612, sean.lin@sunway.cc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI improvement (time frame: 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 NCT05869799, which also lists 14 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 20 Dec 2023.