Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000037107
- Lead Sponsor
- HUMA R&D CORP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1 Subjects who currently are dieting 2 Subjects who have some metal which the abdomen cannot remove 3 Subjects who have bolt in lumbar spine 4 Subjects who have stoma 5 Subjects who plan the examination with barium within one week before each examination day after screening test step 2 6 Subjects who are currently under medical treatment 7 Subjects who are currently under exercise and dietary treatment 8 Subject who have an allergy against trial supplement 9 Subjects who have current disease or history of drug and/or alcoholism 10 Subjects who have current treatment or history of mental disorder and/or sleep disorder 11 Subjects who are night shift or shift workers 12 Subjects with extremely irregular lifestyles such as food and sleep 13 Subjects who have an extreme unbalanced diet 14 Subjects who have serious disease or history 15 Subjects who use health foods, supplements and medicines that affect weight and lipid metabolism 16 Subjects who participated in other clinical trials within one month from the date of obtaining consent, or who plan to participate in other clinical trials during the trial period 17 Subjects who carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition 18 Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 19 Subjects who have a habit of taking a food containing a large amount of lactic acid bacteria for 3 days or more a week 20 Subjects who always use a laxative for defecation 21 Subjects who used probiotics, antibiotics 22 Subjects who have difficulty in keeping records on various questionnaires 23 Subjects who have difficulty in keeping records on various questionnaires 24 Subjects who are judged as unsuitable for the study by the investigator for other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight
- Secondary Outcome Measures
Name Time Method Abdominal visceral fat area, abdominal total fat area, abdominal subcutaneous fat area, BMI, body fat percentage, waist circumference, hip circumference, ratio of waist and hip circumferences, subgroup analysis (BMI, abdominal visceral fat area, sex, defecation frequency)