A study to investigate responders to food ingredients - A randomized, double-blind, placebo-controlled, crossover study
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000045206
- Lead Sponsor
- DeNA Life Science, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 102
Not provided
1) Subjects who are receiving continuous pharmaceutical treatment 2) Subjects with previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive system) 3) Subjects who have hay fever (during the study period) and/or allergic rhinitis (seasonal or year-round) 4) Subjects who are receiving nutrition therapy or physical therapy under doctor's supervision 5) Subjects who are regularly taking OTC medicines, quasi-drugs, and/or any food/functional food claiming an effect on autonomic nervous system, metabolism, and sleep (except for those who will be able to quit taking these after agreeing to participate until the end of the study) 6) Subjects who drink excessively (drinking 60g of pure alcohol or more, for more than five days a week) 7) Subjects with extremely irregular life cycles (e.g., midnight shift work) and/or those with extremely irregular dining habits 8) Subjects with current or past (less than 1 month) experience of participating in other clinical studies at the time of informed consent, or those planning to participate in other clinical studies during or after (within four weeks) the study period 9) Subjects who might be under extreme stress due to large life events (e.g., changing jobs, moving, divorce) that has happened three months prior to agreeing to participate in the study 10) Subjects with difficulty not taking alcohol the day before their scheduled date of the study 11) Subjects with allergy to certain medicine and/or food 12) Subjects with defects in heart rate measurement (subjects with cardiac pacemakers or thick chest hair) 13) Subjects who cannot drink alcohol 14) Subjects who cannot drink energy drinks 15) Female subjects who are pregnant and/or lactating 16) Subjects with a severe symptom of PMS (premenstrual syndrome) 17) Any other subjects who are judged by the principal investigator responsible for the study to be inappropriate to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psychological evaluation Heart rate data
- Secondary Outcome Measures
Name Time Method Genetic polymorphism Interoceptive sense Values and Personality survey Background survey (menstrual cycle, levels of menstrual pain, and beverage intake preferences) Beverages drinking patterns and behaviors Flavor evaluation BMI Stress Lifestyle (obesity)