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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium breve B-3
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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