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The effect of the test food on cold sensitivity and quality of life on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial-

The effect of the test food on cold sensitivity and quality of life on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial- - The effect of the test food on cold sensitivity and quality of life on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043954
Enrollment
40
Registered
2021-05-21
Start date
2021-05-22
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

Study food will be ingested once daily, for 8 weeks. Placebo will be ingested once daily, for 8 weeks.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age between 30 and 59 years at the time of informed consent 2.Japanese male or female 3.Those who have neck stiffness 4.Those who consider themselves feeling of cold 5.BMI of over 18.5 to under 25.0 6.Those who are able to input electronic diary with smartphone / PC 7.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent

Exclusion criteria

Exclusion criteria: 1.Those who has been currently visiting a hospital or treated with any drug or herbal remedy (however, dosing as needed is allowed) for any disease 2.On diet / exercise therapy under the guidance of a doctor 3.Have a current or history of serious illness 4.Those who have heavy anemia 5.Those who are currently taking drugs, quasi-drug products, foods, or supplements which have health claim for improvement of fatigue, stress, cold sensitivity, blood flow, blood pressure 6.Those who are currently employing devices for improvement of fatigue, stress, cold sensitivity, blood flow, blood pressure (such as massage devices, elastic stockings, and low-frequency electric therapy devices). (except for those who can discontinue using such devices during the trial period after obtaining informed consent) 7.Those who have a cold allergy, a drug allergy, or a food allergy. Those who experienced those allergy symptoms. 8.Smokers (who have not been smoking for the last year) 9.Excessive consumption of alcohol (alcohol equivalent 60g or more / day) 10.Those who have menstrual irregularity. 11.Those who donated blood (including plasma or serum) more than 400 mL (men) within three months before obtaining informed consent. 12.Those who donated blood (including plasma or serum) more than 200 mL (women) within three months before obtaining informed consent. 13.Planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial 14.Irregular diet, shift worker, night shift, irregular life rhythm 15.Those who are planning travels to foreign countries during the trial period. 16.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period 17.Participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate 18.Those who were determined by the investigator to be unsuitable for participation in this clinical trial

Design outcomes

Primary

MeasureTime frame
Body surface temperature

Secondary

MeasureTime frame
Body temperature Blood flow Questionnaire for subjective evaluation

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