Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBifidobacterium breve B-3
160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.
DIETARY_SUPPLEMENTControl group
160 mg of placebo is orally administered per day for 12 weeks.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body fat | Change from baseline body fat at 12 weeks | dual energy x-ray absorptiometry (DEXA) |
Countries
South Korea
Outcome results
None listed