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

September 10, 2019 updated by: Sang Yeoup Lee, Pusan National University Yangsan Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Yangsan, Korea, Republic of, 50612
        • Integrated Research Institute for Natural Ingredients and Functional Foods

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bifidobacterium breve B-3 group
160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks.
Dietary supplement: Bifidobacterium breve B-3
160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.
Placebo Comparator: Control group
160 mg of placebo was orally administered per day for 12 weeks.
Dietary supplement: Control group
160 mg of placebo is orally administered per day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: Change from baseline body fat at 12 weeks
dual energy x-ray absorptiometry (DEXA)
Change from baseline body fat at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 02-2018-016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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