NCT03774381

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

December 11, 2018

Last Update Submit

September 10, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body fat

    dual energy x-ray absorptiometry (DEXA)

    Change from baseline body fat at 12 weeks

Study Arms (2)

Bifidobacterium breve B-3 group

EXPERIMENTAL

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

Dietary Supplement: Bifidobacterium breve B-3

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Control group

Interventions

Bifidobacterium breve B-3DIETARY_SUPPLEMENT

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

Bifidobacterium breve B-3 group
Control groupDIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 27\~30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, 50612, South Korea

Location

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sang Yeoup Lee, MD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2018

First Posted

December 13, 2018

Study Start

September 1, 2018

Primary Completion

July 31, 2019

Study Completion

August 1, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

KR(1)