UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052847 |
|---|---|
| Receipt number | R000060310 |
| Scientific Title | Study on the effect of food ingredients on body temperature and energy metabolism |
| Date of disclosure of the study information | 2023/11/21 |
| Last modified on | 2023/11/20 14:12:32 |
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Basic information
Public title
Study on the effect of food ingredients on body temperature and energy metabolism
Acronym
Effect of food ingredients on body temperature and energy metabolism
Scientific Title
Study on the effect of food ingredients on body temperature and energy metabolism
Scientific Title:Acronym
Effect of food ingredients on body temperature and energy metabolism
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effect of a single intake of food ingredients on body temperature and energy metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body surface temperature
Key secondary outcomes
Energy expenditure
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
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
<Duration> Single ingestion
<Test food>
I: Placebo
II: Ingredient 1 -containing food
III: Ingredient 2 -containing food
IV: Ingredient 3 -containing food
V: Ingredient 4 -containing food
*The intervention sequence is Period I to Period V.
*Washout period is for one week and more.
Interventions/Control_2
<Duration> Single ingestion
<Test food>
I: Ingredient 1 -containing food
II: Ingredient 2 -containing food
III: Ingredient 3 -containing food
IV: Ingredient 4 -containing food
V: Placebo
*The intervention sequence is Period I to Period V.
*Washout period is for one week and more.
Interventions/Control_3
<Duration> Single ingestion
<Test food>
I: Ingredient 2 -containing food
II: Ingredient 3 -containing food
III: Ingredient 4 -containing food
IV: Placebo
V: Ingredient 1 -containing food
*The intervention sequence is Period I to Period V.
*Washout period is for one week and more.
Interventions/Control_4
<Duration> Single ingestion
<Test food>
I: Ingredient 3 -containing food
II: Ingredient 4 -containing food
III: Placebo
IV: Ingredient 1 -containing food
V: Ingredient 2 -containing food
*The intervention sequence is Period I to Period V.
*Washout period is for one week and more.
Interventions/Control_5
<Duration> Single ingestion
<Test food>
I: Ingredient 4 -containing food
II: Placebo
III: Ingredient 1 -containing food
IV: Ingredient 2 -containing food
V: Ingredient 3 -containing food
*The intervention sequence is Period I to Period V.
*Washout period is for one week and more.
Interventions/Control_6
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
Key inclusion criteria
(1) Healthy men who are 20 <= years old <40.
(2) Subject who can come to the facility on the designated day.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects whose systolic pressure <90 mmHg.
(2) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks.
(3) 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) The subjects who are contracting diabetes.
(4) Subjects who have severe allergic rhinitis.
(5) Subjects who are on a diet or have a plan.
(6) Subjects who have an unsteady lifestyle because of a working shift or a night shift.
(7) Subjects who drink a lot.
(8) Smoker
(9) Subjects whose BMI is less the 18.5 or over 25.0.
(10) Subjects who are judged as unsuitable for the study by the result of clinical examination and physical examination.
(11) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Maeda |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0719
Akifumi_Maeda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Tateishi |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0537
Homepage URL
Akiko_Tateishi@suntory.co.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2023 | Year | 11 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060310
