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A confirmatory study on the effect of continuous intake of test food on bone metabolism. -A placebo-controlled, randomized, double-blind clinical trial-

A confirmatory study on the effect of continuous intake of test food on bone metabolism. -A placebo-controlled, randomized, double-blind clinical trial- - A confirmatory study on the effect of continuous intake of test food on bone metabolism.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046979
Enrollment
40
Registered
2022-02-27
Start date
2022-04-12
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

Take one packet of the test food with water, warm water, green tea, or coffee before breakfast once a day. Dissolving the food in these solutions will be allowed. Take one packet of the placebo food w

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged between 30 and less than 59 years old. 2. Japanese females. 3. Have anxiety about bone health. 4. BMI between 18.5 and 29.5 kg/m^2. 5. Can use smartphones or PCs to input an electronic diary. 6. Received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Exclusion criteria

Exclusion criteria: 1. Currently undergoing treatment for any disease, or receive medical treatment such as medical drugs or traditional Chinese medicines. Medications used as needed are acceptable. 2. Receiving nutritional and exercise therapy by medical doctors. 3. Have severe diseases or a history of severe diseases. 4. Received hormone replacement therapy within six months before the study. 5. Have experienced bone-related diseases such as bone fracture within six months before the study. 6. Have artificial materials or foreign substances in the bones with surgeries or any reason. 7. Have the Young Adult Mean% less than 70%. 8. Received barium swallow test within 7 days before the day of visit. 9. Have currently been taking commercially available drugs, quasi-drug products, foods, or supplements with any functional claims. However, can discontinue taking these drugs/foods during the trial period is acceptable to join the study. 10. Have allergies to drugs or foods. 11. Planning extremely change lifestyle (such as diet, sleep, or exercise) during the study period. 12. Planning travel to foreign countries during the study period. 13. Taking more than 60 g alcohol/day. 14. Smoking within one year before the trial. 15. Individuals who joined other clinical trials from one month before the trial, individuals who have currently been joined other clinical trials, and also Individuals who are planning to join other clinical trials during the trial. 16. Unsuitable for the study, that judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Blood bone metabolism-related markers Bone mineral density

Secondary

MeasureTime frame
Blood metabolism assessment markers

Countries

Japan

Contacts

Public ContactHirokuni Kayama

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