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A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study.

A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study. - A study to assess the effect of Bifidobacteria ingestion on visceral fat reduction.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023919
Enrollment
80
Registered
2016-09-02
Start date
2016-09-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Ingestion of probiotics (Bifidobacteria) for 12 weeks. Ingestion of placebo for 12 weeks.

Sponsors

KSO Corporation
Lead Sponsor
National Hospital Organization Kyoto Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects who have BMI ranging from 25 to <30.

Exclusion criteria

Exclusion criteria: (1) Subjects who have history or receiving treatment of serious disease (2) Subject with gastrointestinal related disease and undertake medication (3) Subject who is under medication for diabetes, hypertension or dyslipidemia (4) Subject with a history of serious allergy to medicine and food (5) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study (6) Heavy smoker and heavy drinker, or subject with irregular lifestyle (7) Subject who is ineligible due to physician's judgment based on background of subject, physical finding, interview

Design outcomes

Primary

MeasureTime frame
abdominal visceral fat area (Time frame: 12 weeks)

Secondary

MeasureTime frame
Body composition (body weight, body fat mass, body fat percentage, BMI, visceral fat area, subcutaneous fat area, total fat area), Waist circumference, Serum lipids (Total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides), Diabetes associated markers (fasting plasma glucose, HbA1c, glycoalbumin, fasting serum insulin), liver function (AST, ALT, gamma-GTP, ALP), inflammatory marker (hs-CRP, LBP), enteric environment (enterobacterial flora analysis, defecation frequency)

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation President-director

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026