Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869799
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-03-15
Brief Title:
Effect of Vigiis 101 Lactic Acid Bacteria Powder on Body Weight and Body Fat in Overweight Participants
Sponsor:
SunWay Biotech Co LTD
Organization:
SunWay Biotech Co LTD
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None