Unique ID issued by UMIN | UMIN000043954 |
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Receipt number | R000050200 |
Scientific Title | The effect of the test food on cold sensitivity and quality of life on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial- |
Date of disclosure of the study information | 2021/05/21 |
Last modified on | 2021/10/07 11:44:31 |
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-
The effect of the test food on cold sensitivity and quality of life on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial-
Japan |
Healthy adults
Adult |
Others
NO
This trial aims to investigate the effect of a single consumption of the test food, or continuous consumption of the test food for 8 weeks on cold sensitivity and discomfort of shoulder and waist through improving blood flow.
Safety,Efficacy
Body surface temperature
Body temperature
Blood flow
Questionnaire for subjective evaluation
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Study food will be ingested once daily, for 8 weeks.
Placebo will be ingested once daily, for 8 weeks.
30 | years-old | <= |
59 | years-old | > |
Male and Female
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
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
40
1st name | Hiroyuki |
Middle name | |
Last name | Onda |
S&B FOODS INC.
Development and Manufacturing group, Central research institute, Functional food research and development unit
174-8651
38-8 ,Miyamoto-cho,Itabashi-ku, Tokyo
03-3558-5531
hiroyuki_onda@sbfoods.co.jp
1st name | Hirokuni |
Middle name | |
Last name | Kayama |
IMEQRD Co., Ltd
Sales department
104-0061
6-2-1 Ginza Chuo-ku Tokyo Japan
03-6704-5968
h-kayama@imeqrd.co.jp
IMEQRD Co., Ltd
S&B FOODS INC.
Profit organization
Suda Clinic institutional review board
2-8-14,Takadanobaba,Shinjyuku,Tokyo
03-6704-5968
n-yuzawa@imeqrd.co.jp
NO
2021 | Year | 05 | Month | 21 | Day |
Unpublished
40
Completed
2021 | Year | 03 | Month | 26 | Day |
2021 | Year | 03 | Month | 30 | Day |
2021 | Year | 05 | Month | 22 | Day |
2021 | Year | 07 | Month | 18 | Day |
2021 | Year | 04 | Month | 16 | Day |
2021 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050200
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