NCT05869799

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

Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants: a Randomized, Double-blinded, Placebo-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: SunWay Biotech Co., LTD. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Weight
• Body Fat
• Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vigiis 101 Lactobacillus Capsules	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.
DIETARY_SUPPLEMENT	Placebo Capsules	Maltodextrin was used as a placebo

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-03-31
• Completion: 2025-04-30
• First posted: 2023-05-22
• Last updated: 2023-12-20

Locations

1 site across 1 country: Taiwan