Effect of Vigiis 101 Lactic Acid Bacteria Powder on Weight and Fat in Overweight Adults
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 testing if a new lactic acid bacteria powder can help overweight adults lose weight and reduce body fat over 14 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | SunWay Biotech Co., LTD. Industry-sponsored |
| Locations | 1 site (Taipei City) |
| Trial ID | NCT05869799 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Vigiis 101 lactic acid bacteria powder on body weight and body fat in overweight participants. It is a randomized, double-blind, placebo-controlled trial lasting 14 weeks, divided into screening, treatment, and follow-up phases. Participants are randomly assigned to receive either the Vigiis 101 capsules or a placebo, and their body composition and health metrics are monitored throughout the study. Daily diaries are maintained by participants to track their consumption, diet, physical activity, and any side effects experienced.
Who should consider this trial
Good fit: Ideal candidates are overweight adults aged 20-65 with a BMI between 23 and 29.9.
Not a fit: Patients who are pregnant, lactating, or have significant health issues such as diabetes or heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention for weight management in overweight individuals.
How similar studies have performed: Previous studies have shown promise in using probiotics for weight management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. 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. 3. Subjects who agree to participate in this trial and voluntarily agree to the test consent in writing. Exclusion Criteria: 1. Subjects who are pregnant or lactating or expecting pregnancy. 2. Those with gallbladder disease, gastrointestinal disease, gout, porphyria (Porphyria) or a history of stomach weight control surgery. 3. Subjects suffering from high blood pressure (≥160/100 mmHg, after resting for 10 minutes) or taking diuretics. 4. Subjects with diabetes (fasting blood glucose (≥125 mg/dL). 5. 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. 6. Suffering from depression, schizophrenia, alcoholism, drug addiction and other mental disorders or taking drugs (such as psychotropic drugs, β receptor blockers). 7. 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. 8. Subjects judged to be unable to exercise due to severe musculoskeletal diseases. 9. Subjects who consumed probiotics or expected to consume probiotics within 2 weeks before the screening visit. 10. 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: (1) 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. (3) 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. (5) 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. (7) 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. (8) The project host or the sponsor may also suspend the entire experiment if necessary.
Where this trial is running
Taipei City
- Tri-Service General Hospital, National Defense Medical Center — Taipei City, Taiwan (Recruiting)
Study contacts
- Principal investigator: WEN-HUI FANG, Ph. D. — Chief of Family medicine department
- Study coordinator: Sean Lin
- Email: sean.lin@sunway.cc
- Phone: 02-27929568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.