Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants

Launched by SUNWAY BIOTECH CO., LTD. · May 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a product called Vigiis 101 Lactic Acid Bacteria Powder on body weight and body fat in people who are overweight. The study will last for 14 weeks and is designed to see whether this powder can help participants manage their weight more effectively. To be eligible for this trial, participants must be between 20 and 65 years old, have a body mass index (BMI) between 23 and 29.9, and be able to give informed consent. However, pregnant or breastfeeding women, and individuals with certain health conditions (like diabetes or heart disease), are not eligible to participate.

During the trial, participants will receive either the Vigiis powder or a placebo, which is a product that looks the same but does not contain any active ingredients. This means that neither the participants nor the researchers will know who is receiving the actual treatment and who is receiving the placebo, helping to ensure unbiased results. Participants will be monitored throughout the study, and if they experience any serious side effects or are unable to follow the study guidelines, they may need to withdraw from the trial. Overall, this study aims to find out if Vigiis 101 can be a helpful option for those looking to manage their weight.

Gender

ALL

Eligibility 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.