Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Control group; Dietary Supplement: Bifidobacterium breve B-3

• Registration Number: NCT03774381
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults

Detailed Description

Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in adults by a randomized, double-blind, and control-group study.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Primary Completion: 2019-07-31
• Study Completion: 2019-08-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI 27~30 kg/m2

Exclusion Criteria

• Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
• Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
• Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
• Those who are treated with hypothyroidism or hyperthyroidism
• Creatinine levels: more than twice the normal upper limit
• Aspartate transaminase (AST), Alanine transaminase (ALT) levels: more than twice the normal upper limit
• Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
• Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
• Participated in the commercial obesity program within the last 3 months.
• If you have participated or are planning to participate in another clinical trial within the past month If yes
• Alcohol abuser
• Smoking abstinence within 3 months
• If they are pregnant or lactating or have a pregnancy plan during the clinical trial
• Those with allergic reactions to the constituent food
• Any person deemed inappropriate by the researcher for other reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	160 mg of placebo was orally administered per day for 12 weeks.
Bifidobacterium breve B-3 group	Bifidobacterium breve B-3	160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Body fat	Change from baseline body fat at 12 weeks	dual energy x-ray absorptiometry (DEXA)

Trial Locations

Locations (1)

Integrated Research Institute for Natural Ingredients and Functional Foods; 🇰🇷 Yangsan, Korea, Republic of