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

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ClinicalTrials.gov Identifier: NCT03774381
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, 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

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Bifidobacterium breve B-3 Dietary Supplement: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : July 31, 2019

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.




Primary Outcome Measures :
  1. Body fat [ Time Frame: Change from baseline body fat at 12 weeks ]
    dual energy x-ray absorptiometry (DEXA)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774381


Contacts
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Contact: Sang Yeoup Lee, MD 3602860 ext 55 saylee@pnu.edu

Locations
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Korea, Republic of
Integrated Research Institute for Natural Ingredients and Functional Foods Recruiting
Yangsan, Korea, Republic of, 50612
Contact: Sang Yeoup Lee, MD    82-55-360-2860    saylee@pnu.edu   
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee, MD Pusan National University Yangsan Hospital

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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03774381     History of Changes
Other Study ID Numbers: 02-2018-016
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No