Clinical trial NCT05869799: Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Weight
Body Fat
Overweight
Lead sponsor: SunWay Biotech Co., LTD.
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

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.

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.

Primary outcomes:
measure: BMI improvement
timeFrame: 12 weeks
Secondary outcomes:
measure: Other body index improvements
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Chief of Family medicine department
name: WEN-HUI FANG, Ph. D.
role: PRINCIPAL_INVESTIGATOR
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