Status:
COMPLETED
Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Obesity
Eligibility:
All Genders
20-60 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- BMI 27\~30 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03774381
Start Date
September 1 2018
End Date
August 1 2019
Last Update
September 11 2019
Active Locations (1)
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1
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, South Korea, 50612