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A verification study of the improving effect of consumption of the test beverage on resting energy expenditure

A verification study of the improving effect of consumption of the test beverage on resting energy expenditure: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the improving effect of consumption of the test beverage on resting energy expenditure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052435
Enrollment
40
Registered
2025-01-16
Start date
2023-10-07
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: Four weeks Test beverage: Milk beverage containing 10 billion Bifidobacterium animalis subsp. lactis GCL2505 and 5 g of inulin Administration: Take one bottle (100 g) once daily after brea

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 25 or more and 60 or less 4. Healthy subjects 5. Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2 6. Subjects with body fat percentage of 15% or more for men and 25% or more for women 7. The bottom 40 subjects with low resting metabolism among those who meet inclusion criteria No.1~6 without meeting any of exclusion criteria

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" 5. Subjects who are taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test beverage related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. 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 9. Subjects who have taken antibiotics within the last 28 days before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
Resting energy expenditure at four weeks after consumption (4w)

Secondary

MeasureTime frame
1. Resting energy expenditure at two weeks after consumption (2w) 2. Respiratory quotient, energy expenditure, glucose oxidation rate, carbohydrate oxidation rate, fat oxidation rate, basal metabolic rate, body mass index (BMI), body weight, basal metabolism, body fat percentage, muscle mass, acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and Bifidobacterium in the stool at 2w and 4w

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