UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034138
Receipt number R000038918
Scientific Title A study to evaluate the effect of food ingredient on body temperature. (test ID:SBF-2018-04-HEGD)
Date of disclosure of the study information 2018/09/15
Last modified on 2019/01/07 12:35:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study to evaluate the effect of food ingredient on body temperature. (test ID:SBF-2018-04-HEGD)

Acronym

A study to evaluate the effect of food ingredient on body temperature.

Scientific Title

A study to evaluate the effect of food ingredient on body temperature. (test ID:SBF-2018-04-HEGD)

Scientific Title:Acronym

A study to evaluate the effect of food ingredient on body temperature.

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of food ingredient on body temperature.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body temperature

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

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

6

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Subjects will take the food ingredient-containing beverage (1) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (2) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-free beverage once a day.

Interventions/Control_2

Subjects will take the food ingredient-containing beverage (1) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-free beverage once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (2) once a day.

Interventions/Control_3

Subjects will take the food ingredient-containing beverage (2) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (1) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-free beverage once a day.

Interventions/Control_4

Subjects will take the food ingredient-containing beverage (2) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-free beverage once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (1) once a day.

Interventions/Control_5

Subjects will take the food ingredient-free beverage once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (1) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (2) once a day.

Interventions/Control_6

Subjects will take the food ingredient-free beverage once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (2) once a day. After 3 or 4 days of washout period, subjects will take the food ingredient-containing beverage (1) once a day.

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Healtya males and females aged 20 to less than 40 years old.
(2) Females who have stable menstrual cycle, which is 28 to 32 days (plus or minus 2 days)

Key exclusion criteria

(1) Subjects who have a disease and use medicines currently.
(2) Subjects who are applicable to following items.
a) Subjects with disease on heart, liver, kidney or other organs complication.
b) Subjects with a previous history of disease on circulatory organs.
c) Subjects who have respiratory disease.
d) Subjects who was diagnosed with diabetes.
e) Subjects with test food allergy.
(3) Subjects whose systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg
(4) Subjects whose systolic blood pressure <90 mmHg.
(5) Females in pregnancy, lactation and scheduled pregnancy period.
(6) Subjects who constantly use foods for specified health uses, functional foods, supplements, and/or external medicine.
(7) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
(8) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanori Teramoto

Organization

Suntory Beverage & Food Limited

Division name

Development & design department

Zip code


Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa

TEL

050-3182-6114

Email

Takanori_Teramoto@suntory.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eiji Fukushima

Organization

Suntory Beverage & Food Limited

Division name

Development & design department

Zip code


Address

13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa

TEL

050-3182-0544

Homepage URL


Email

Eiji_Fukushima@suntory.co.jp


Sponsor or person

Institute

Suntory Beverage & Food Limited

Institute

Department

Personal name



Funding Source

Organization

Suntory Beverage & Food Limited

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


Address


Tel


Email



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

2018 Year 09 Month 15 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


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

2018 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 14 Day

Last modified on

2019 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038918


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name