Examination study on abdominal visceral fat reducing action by functional food intake -Randomized placebo-controlled double-blind parallel group comparison study
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000026291
- Lead Sponsor
- Maruzen Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Not provided
1. Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 2. Subjects who fall under the diagnostic criteria of metabolic syndrome 3. Subjects who received medication treatment or surgery due to serious illness or injury within 2 months from the start of this study 4. Subjects who use drugs of glycometabolism, lipidmetabolism, or reducing high blood pressure 5. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them 6. Pregnant and lactating female, or who wish to get pregnant during the study period 7. Heavy dinkers 8. Subjects who feel bad mood by blood collection in past 9. Subjects who donated 200 mL or more of blood within 1 month from the start of the test or subjects who plan to do so during the test period 10. Subjects who have been constipated for more than 5 days 11. Shift worker 12. Subjects who have allergy related to the test foods 13. Subjects already participating in other clinical trials, subjects planning to participate during this examination period 14. Subjects who can not agree with the purpose of this test conducted in advance 15. Subjects who are ineligible due to physician's judgment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Efficacy> Abdominal visceral fat area, at 8 and 12 weeks after intake <Safety> Side effect incidence
- Secondary Outcome Measures
Name Time Method <Efficacy> Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake HbA1c and adiponectin at 12 weeks after intake <Safety> Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items