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Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study

Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria: A randomized, double-blind, placebo-controlled, parallel-group study - Study of the body fat-reducing effect of the 12-week intake of food containing lactic acid bacteria

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027709
Enrollment
100
Registered
2017-06-12
Start date
2017-08-25
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

Overweight

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy men and women of 20 to 64 years age 2)Subjects whose body mass indexes were 25 to 30 at the screening period 3)Subjects giving written informed consent

Exclusion criteria

Exclusion criteria: 1)Subjects with severe onset of obesity-related disease (impaired glucose tolerance, dyslipidemia, hypertension, hyperuricemia, coronary artery disease, cerebral infarction, fatty liver, menstrual disorder and pregnancy complications, sleep apnea syndrome or obesity hypoventilation syndrome, orthopedic surgery, obesity-related kidney disease) 2)Subjects with food allergy or lactose intolerance 3)Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in three months before screening test 4)Subjects with a habit of oral medication, supplements, health food affecting obesity, hyperlipidemia, glucese or lipid matabolism in three months before screening test, and subjects who will take these in the test period. 5)Subjects who are regularly practicing intense exercise (exercising for the purpose of muscle strengthening, attending exercise facilities more than three times in a week, etc.) 6)Subjects who have been drug dependency or alcohol dependency 7)Subjects who drink a lot of alcohol, and subjects who can not abstain from drinking from two days before the examination date 8)Subjects who have metal in the measurement site of CT scan 9)Subjects who contain cardiac pacemaker, implantable defibrillator 10)Subjects who have been diagnosed with familial hyperlipemia 11)Subjects in pregnancy or in nursing 12)Subjects whose eating habits are extremely irregulae (ex. midnight and irregulae shift worker) 13)Subjects who participated in other clinical trials within one month before the agreement of participants in this study 14)Subjects with claustrophobia 15)Subjects who are judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Abdominal total fat area Abdominal visceral fat area Abdominal subcutaneous fat area

Secondary

MeasureTime frame
Body weight Body mass index Body fat percentage Waist circumference, Hip circumference, Waist circumference/hip circumference Blood fat level (triglyceride, total cholesterol, HDL cholesterol, LDL cholesterol) Blood glucose level HbA1c Insulin HOMA-IR Blood ketone bodies level Blood inflammatory cytokines Blood adiponectin

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp81-3-3452-7733

Outcome results

None listed

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