Effects of consumption of the test food on body fat in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Effects of consumption of the test food on body fat in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on body fat in healthy Japanese

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061655

Enrollment

Registered

2026-05-22

Start date

2026-05-22

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Healthy Japanese

Interventions

Duration: 12 weeks Test product: Capsule containing Lentilactobacillus kefiri YRC2606 powder Administration: Take one capsule with water without chewing per day. *If you forget to take the test f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals with a BMI >= 23 kg/m2 and < 30 kg/m2 at Scr

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measured value of abdominal visceral fat area at 12 weeks after intervention (12w)	—

Secondary

Measure	Time frame
1. The change and percentage change of abdominal visceral fat area at 12w from screening (Scr) 2. The measured values, the amount and percentage of changes from before consumption of abdominal total fat area and abdominal subcutaneous fat area at 12w 3. The measured values, the changes and percentage changes of body weight, body mass index (BMI), body fat percentage, lean body mass, fat mass (whole body, right leg, left leg, right arm, left arm, trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, trunk), and waist circumference at 12w from Scr 4. Individuals who experienced adverse events 5. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 6. Physical measurements, urinalysis, and peripheral blood test	—

Measure

Time frame

1. The change and percentage change of abdominal visceral fat area at 12w from screening (Scr) 2. The measured values, the amount and percentage of changes from before consumption of abdominal total fat area and abdominal subcutaneous fat area at 12w 3. The measured values, the changes and percentage changes of body weight, body mass index (BMI), body fat percentage, lean body mass, fat mass (whole body, right leg, left leg, right arm, left arm, trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, trunk), and waist circumference at 12w from Scr 4. Individuals who experienced adverse events 5. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Scr 6. Physical measurements, urinalysis, and peripheral blood test

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026