Effects of consumption of the test food on muscle and body fat in healthy Japanese subjects

Effects of consumption of the food containing lactic acid bacteria on muscle and body fat in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the food containing lactic acid bacteria on muscle and body fat in healthy Japanese subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050371

Enrollment

Registered

2023-02-22

Start date

2023-02-24

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

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test food: Capsule containing killed-Lactobacillus plantarum TWK10 powder Administration: Tale one capsule with water at any time once daily *If you forget to take the test foo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or above and 64 or below 4. Healthy subjects 5. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
Lean body mass at 12 weeks after consumption (12w)	—

Secondary

Measure	Time frame
The visceral fat area, subcutaneous fat area, total fat area, body weight, body mass index (BMI), body fat percentage, fat mass (whole body, right leg, left leg, right arm, left arm, and trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), and abdominal circumference at 12w	—

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: Jul 3, 2026