NCT05710055

The Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

A Randomized, Double-blind, Controlled Trial to Evaluate the Efficacy on Overweight With Oral Supplemenation of Probiotics and Prebiotics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Shenzhen Precision Health Food Technology Co. Ltd., · Other Government
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to evaluate the efficacy of probiotics with prebiotics on overweight. 200 eligible participants with overweight will be enrolled and randomized to consume four study products for 3 months. Reseachers will compare the four groups to evaluate whether there is significant improvement on overweight for participants in the study product of probiotics with prebiotics.

Detailed description

This study is a multi-center, four arms, randomized, double-blind controlled trial. 200 Eligible participants of 25 to 45 years old with overweight will be randomized in four equal size groups to receive one of the four products of probiotics with and without prebiotics and consume one bottle once in a day for 3 months. All participants will visit the study site for 3 times, once a month, all relevant clinical data will be captured, and recorded in to CTMS (Clinical Trial Management System). Data will be analyzed and reported after the completion of the study.

Conditions

• Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Study product A (Wonderlab wonder4shape)	Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
DIETARY_SUPPLEMENT	Study product B (Wonderlab wonder4shape)	Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
DIETARY_SUPPLEMENT	Study product C (Wonderlab wonder4shape)	Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months
DIETARY_SUPPLEMENT	Study product D	Partipants in this arm need to consume one bottle (2g) of this product once a day for 3 months

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2023-02-02
• Last updated: 2023-11-24

Locations

2 sites across 1 country: China