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Completed

NCT Number: NCT03774381

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

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium breve B-3

Dietary Supplement

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

Control group

Dietary Supplement

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

Primary outcomes

  1. Body fat

    Time frame: Change from baseline body fat at 12 weeks

    dual energy x-ray absorptiometry (DEXA)

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2018
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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