Effects of a Test Food for Reducing Body Fat.
- Conditions
- /A (healthy adults)
- Registration Number
- JPRN-UMIN000034075
- Lead Sponsor
- MISUZU-CO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 46
Not provided
[1]Individuals whose BMI is over 25.0 and abdominal visceral fat mass measured with FatScan is over 100 cm2 (individuals who are visceral fat type obesity defined in Guidelines for the Management of Obesity Disease). [2]Individuals using medical products. [3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [4]Individuals who used or applied a drug for treatment of disease in the past 1 month. [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [6]Individuals who are a patient or have a history of or endocrine disease. [7]Individuals who have gained or lost 2 kg of body weight in the past 3 months. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals with serious anemia. [10]Individuals who are sensitive to test product or other foods, and medical products. [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [13]Individuals having a habit to intake a food containing the component of the test food. [14]Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months. [15]Individuals who are or are possibly, or are lactating. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [1]Abdominal visceral fat mass (Week 0, Week 12); BMI (Week 0, Week 4, Week 8, Week 12)
- Secondary Outcome Measures
Name Time Method *Secondary indexes [1]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8, Week 12) [2]Waist girth, hip girth / waist-hip ratio (Week 0, Week 8, Week 12) *Safety [1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12) [2]Hematologic test (Week 0, Week 4, Week 8, Week 12) [3]Blood biochemical test (Week 0, Week 4, Week 8, Week 12) [4]Urine analysis (Week 0, Week 4, Week 8, Week 12) [5]Doctor's questions (Week 0, Week 4, Week 8, Week 12) *Other indexes [1]Subject's diary (From the first day of ingestion of a test material to the last day of the test) [2]Dietary survey (3 days prior to each inspection date)