A Study on the Effect of Food Containing Plant Extract on Energy Metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- Conditions
- o
- Registration Number
- JPRN-UMIN000036693
- Lead Sponsor
- KSO Corporation
- Brief Summary
Statistically significant difference was confirmed in the energy expenditure. Statistically significant difference was not confirmed in the respiratory quotient.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 80
Not provided
(1) Subjects who contract chronic disease and are under treatment. (2) Subjects who have a history of and/or contract serious diseases (eg, liver and kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (3) Subjects who are judged to correspond to diabetic type, have hypertension and/or have symptoms of anemia by the screening tests. (4) Subjects who have declared allergic reaction to ingredients of test foods. (5) Subjects who can't stop using medicines, quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting energy metabolism during test periods. (6) Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or a habit of drinking not less than 5 days a week. (7) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (8) Subjects who can't stop drinking from 2 days before each measurement. (9) Subjects who have a habit of smoking. (10) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (11) Subjects who are judged as unsuitable for the current study by the investigator through the screening tests. (12) Subjects who are shiftworker and/or midnight-shift worker. (13) Subjects who have regular exercise not less than 2 days a week. (14) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (15) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Energy metabolism
- Secondary Outcome Measures
Name Time Method