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

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Bifidobacterium breve B-3; Dietary Supplement: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03774381

02-2018-016

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Bifidobacterium breve B-3 group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Bifidobacterium breve B-3

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Control group