NCT04677738

Investigation of the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of a Bifidobacterium Breve Strain on Fat Loss in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Morinaga Milk Industry Co., LTD · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.

Detailed description

In early adulthood, excess body weight is a risk factor associated with several health complications later on in life and probiotics have been used for decades for maintaining intestinal health, and in recent years probiotics have been proposed for weight management. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.

Conditions

• Obesity
• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. breve strain	Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks.
DIETARY_SUPPLEMENT	Placebo	Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks.

Timeline

• Start date: 2020-08-20
• Primary completion: 2024-01-05
• Completion: 2024-01-05
• First posted: 2020-12-21
• Last updated: 2025-10-20
• Results posted: 2025-03-06

Locations

1 site across 1 country: Canada