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A confirmatory study examining effects of continuous intake of test food on healthy adults

A confirmatory study examining effects of continuous intake of test food on healthy adults - A confirmatory study examining effects of continuous intake of test food on healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031907
Enrollment
66
Registered
2018-03-26
Start date
2018-04-21
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 4 capsules of test food t.i.d. Take 4 capsules of placebo t.i.d.

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Age:50 to 69 years old 2.Gender:Women 3.Healthy adults (We define "healthy adults" as those who currently have neither severe organ damage nor a particular disease, who currently do not receive treatment associated with those disorders, and who currently do not receive any kind of drug treatment. We judge whether or not a candidate meets this definition according to the self-report submitted when a clinical trial is commenced) 4.Postmenopausal women 5.Those who can give their written informed consent

Exclusion criteria

Exclusion criteria: 1.Those who currently receive continuous drug treatment (except for drugs that are taken as needed) 2.Those who currently undergo dietary or exercise therapy under the direction of physicians 3.Those with a past medical history of any of the following: hepatic disease, severe disorder (kidney, endocrine, cardiovascular, gastrointestinal, and lung diseases, and blood and metabolic disorders), or complications 4.Those with a past medical history of mental disorder (such as depression) 5.Those with a past and current medical history of drug or food allergy 6.Those who work night shifts or irregular shifts 7.Those who currently take health food and supplements (except for those who can stop taking them after they have signed an informed consent form) 8.Smokers 9.Those who currently take warfarin product (such as Warfarin, Warlin, Arefarin, Warfarin K, etc.) 10.Those who have metallic orthopedic implants 11.Those who underwent barium enema in 3 days before the commencement of this clinical trial 12.Those who have done fingernail or toenail designs on the day of a bone density test 13.Those who are participating in other clinical trials or participated in the past 1 month and then took their test products 14.Any other conditions, in the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial

Design outcomes

Primary

MeasureTime frame
muscle mass, bone density

Secondary

MeasureTime frame
Markers in blood (osteocalcin, TRACP-5b, BDNF, FSH, LH, estrone, HDL-C, LDL-C, TC, and TG) and urine (deoxypyridinoline), scores of Cognitrax, vital signs, QOL questionnaire (SF-36, bowel habit 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