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

NCT ID: NCT03774381

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-08-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bifidobacterium breve B-3 group

160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks.

Group Type: EXPERIMENTAL

Bifidobacterium breve B-3

Intervention Type: DIETARY_SUPPLEMENT

160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.

Control group

160 mg of placebo was orally administered per day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DIETARY_SUPPLEMENT

160 mg of placebo is orally administered per day for 12 weeks.

Interventions

Bifidobacterium breve B-3

160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Control group

160 mg of placebo is orally administered per day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, , South Korea

Countries

South Korea

Other Identifiers

02-2018-016

Identifier Type: -

Identifier Source: org_study_id