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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034138
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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