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A study to investigate responders to food ingredients - A randomized, double-blind, placebo-controlled, crossover study -

A study to investigate responders to food ingredients - A randomized, double-blind, placebo-controlled, crossover study - - A study to investigate responders to food ingredients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045206
Enrollment
102
Registered
2022-10-01
Start date
2021-09-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Participants will intake placebo (200 mL) within 15 minutes Participants will intake test liquid 1(200 mL) within 15 minutes Participants will intake test liquid 2(200 mL) within 15 minutes Participan

Sponsors

DeNA Life Science, Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy men and women, aged 20-59 years, at the time of an informed consent 2) Subjects who have given written consent to participate in research conducted by DeNA Life Science using samples and information obtained through MYCODE, the genetic testing service 3) Subjects that are given sufficient explanation about the purpose and contents of the study, and those agreed and volunteered to participate with good understanding of the study 4) Subjects who are able to come to the designated study date and participate in the study 5) Subjects with BMI less than 30.0 6) Non-smokers (those that have not smoked in the past year)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Psychological evaluation Heart rate data

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactRyuichiro Kurata

DeNA Life Science, Inc MYCODE service Dept

IRB_dis@dena.com0120-08-4946

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026