UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043954
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

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Basic information

Public 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-

Acronym

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

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-

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body surface temperature

Key secondary outcomes

Body temperature
Blood flow
Questionnaire for subjective evaluation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

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

Interventions/Control_2

Placebo will be ingested once daily, for 8 weeks.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

59 years-old >

Gender

Male and Female

Key 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

Key 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

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Onda

Organization

S&B FOODS INC.

Division name

Development and Manufacturing group, Central research institute, Functional food research and development unit

Zip code

174-8651

Address

38-8 ,Miyamoto-cho,Itabashi-ku, Tokyo

TEL

03-3558-5531

Email

hiroyuki_onda@sbfoods.co.jp


Public contact

Name of contact person

1st name Hirokuni
Middle name
Last name Kayama

Organization

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL


Email

h-kayama@imeqrd.co.jp


Sponsor or person

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

S&B FOODS INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 05 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

40

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 03 Month 26 Day

Date of IRB

2021 Year 03 Month 30 Day

Anticipated trial start date

2021 Year 05 Month 22 Day

Last follow-up date

2021 Year 07 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 04 Month 16 Day

Last modified on

2021 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050200


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name