Skip to content

A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL: randomized, placebo-controlled, double blind, parallel-group trial

A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL: randomized, placebo-controlled, double blind, parallel-group trial - A study of the effect of continuous intake of test food on body composition, blood markers of glucose/lipid metabolism, blood pressure, and QoL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049119
Enrollment
66
Registered
2022-10-14
Start date
2022-10-15
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

Subjects take 2 capsules of test food twice a day (after breakfast and after dinner: 4 capsules a day) with cold or lukewarm water for 12 weeks. Subjects take 2 capsules of placebo food twice a day (a

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Those who are aged between 20 and 65 yeas at the time of informed consent. 2. Healthy Japanese males and females. 3. Subjects whose BMI is between 23.0 kg/m2 and 30.0 kg/m2. 4. Those who can record the electronic diary using smartphones or PCs. 5. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose, and made the written agreement.

Exclusion criteria

Exclusion criteria: Subjects -- 1. who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease. 2. with any of atopic dermatitis, bronchial asthma, chronic bronchitis, acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, deviated nasal septum. 3. who are on diet / exercise therapy under the guidance of a doctor. 4. who currently have or have history of severe diseases. 5. who are on desensitization therapy. 6. daily taking medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to body fat or slimming. The subjects who can stop taking those medicine or foods during the study are also excluded. 7. daily taking medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods other than criteria 6, except subjects who can stop taking those foods during the study. 8. daily consuming foodstuffs related to the test food with high frequency, except subjects who can refrain from taking these foodstuffs during the study. 9. who currently have or have a history of food and/or drug allergies. 10. who have or have a history of alcoholism or drug addiction. 11. who will take alcohol the day before the visit for tests. 12. routinely taking alcohol more than 60 g/day. 13. with excessive daily smoking: 20 cigarettes a day or more. 14. having plans of major change on their lifestyle (e.g., diet, sleep, and exercise) during the study period. 15. planning to travel abroad during the study period. 16. Currently pregnant, breast-feeding or planning to get pregnant during the study period. 17. who joined or are currently joining other clinical trials within 1 month before receiving informed consent in this study. 18. judged by the physician to be unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Body composition Blood markers test Blood pressure QoL questionnaire

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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