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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774381
• Other study ID #: 02-2018-016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2019
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Bifidobacterium breve B-3
160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.
• Control group
160 mg of placebo is orally administered per day for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Integrated Research Institute for Natural Ingredients and Functional Foods	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body fat	dual energy x-ray absorptiometry (DEXA)	Change from baseline body fat at 12 weeks