UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of food ingredient on body temperature. (test ID:SBF-2018-04-HEGD)
Title of the study (Brief title)	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	Takanori Teramoto
Organization	Suntory Beverage & Food Limited
Division name	Development & design department
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	Eiji Fukushima
Organization	Suntory Beverage & Food Limited
Division name	Development & design department
Address	13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL	050-3182-0544
Homepage URL
Email	Eiji_Fukushima@suntory.co.jp

Sponsor
Institute	Suntory Beverage & Food Limited
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038918