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

UMIN ID: UMIN000054231

Registered date:23/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Japanese
• Date of first enrollment: 2024/04/23
• Target sample size: 96
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Duration: 12 weeks Test food: Beverage containing D-beta-hydroxybutyric acid (D-BHB) (BHB 2.9 g/day) [Normal-dose group] Administration: Take one bottle per day two hours before dinner. *If you cannot take the test food two hours before dinner, take it as soon as you remember. However, daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks Test food: Beverage containing D-BHB (BHB 1.5 g/day) [Low-dose group] Administration: Take one bottle per day two hours before dinner. *If you cannot take the test food two hours before dinner, take it as soon as you remember. However, daily dose should be taken within the day and not carried over to the next day.
Duration: 12 weeks Test food: Beverage not containing D-BHB [Placebo group] Administration: Take one bottle per day two hours before dinner. *If you cannot take the test food two hours before dinner, take it as soon as you remember. However, daily dose should be taken within the day and not carried over to the next day.

Outcome(s)

• Primary Outcome: 1. The measured value of visceral fat area at 12 weeks after consumption (12w) [Low-dose group vs. Placebo group] 2. The measured value of BMI at 12w [Low-dose group vs. Placebo group]
• Secondary Outcome: 1. The measured value of visceral fat area at 12w [Normal-dose group vs. Placebo group] 2. The amount and rate of change from screening (before consumption; Scr) of visceral fat area at 12w [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group] 3. The measured values of total fat area and subcutaneous fat area at 12w, and the amount and rate of changes of them from Scr [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group] 4. The measured value of BMI at 12w [Normal-dose group vs. Placebo group] 5. The amount and rate of change of BMI from Scr to 12w [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group] 6. The measured values of body weight, body fat percentage, and waist circumference at 12w, and the amount and rate of changes of them from Scr [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group] 7. The measured values of each item in an original questionnaire at 12w [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group] 8. The measured values of basal body temperature at PERIOD2~13 and the amount and rate of changes of them from baseline [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group]* 9. The measured values of total ketones, acetoacetic acid, and 3-hydroxybutyric acid at 12w, and the amount and rate of changes of them from Scr [Normal-dose group vs. Placebo group, Low-dose group vs. Placebo group] *PERIOD1 is defined as the seven days from seven days before the start of the intervention to the day before the start of the intervention. The average value of basal body temperature at PERIOD1 is defined as the baseline. PERIOD2~13 are defined as periods separated by seven days from the day of the start of the intervention.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and 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) and supplements 6. Individuals who are allergic to medicines and/or the test product related products 7. Individuals who exercise at least three times per week 8. Individuals whose lifestyles (particularly dietary habits) are irregular due to working a late-night shift or others 9. Individuals who are on extreme diets, such as "no carbohydrates at all" 10. Individuals who are on a diet 11. Individuals who are pregnant, lactating, or planning to become pregnant during this study 12. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 13. Individuals 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: OSAKA GAS CO., LTD.