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

UMIN ID: UMIN000052435

Registered date:16/01/2025

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy Japanese subjects
• Date of first enrollment: 2023/10/07
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 breakfast *If you forget to take the test beverage, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Four weeks Test beverage: Placebo milk beverage Administration: Take one bottle (100 g) once daily after breakfast *If you forget to take the test beverage, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: Resting energy expenditure at four weeks after consumption (4w)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 25years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: ORTHOMEDICO Inc.
• Secondary Sponsor: Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
• Source(s) of Monetary Support: Ezaki Glico Co., Ltd.