UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038204 |
|---|---|
| Receipt number | R000043542 |
| Scientific Title | Trial of the efficacy of continuous intake of food ingredients on energy production(SWE-2019-06-HBKS) |
| Date of disclosure of the study information | 2021/03/30 |
| Last modified on | 2020/07/22 11:59:22 |
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Basic information
Public title
Trial of the efficacy of continuous intake of food ingredients on energy production(SWE-2019-06-HBKS)
Acronym
Trial of the efficacy of continuous intake of food ingredients on energy production
Scientific Title
Trial of the efficacy of continuous intake of food ingredients on energy production(SWE-2019-06-HBKS)
Scientific Title:Acronym
Trial of the efficacy of continuous intake of food ingredients on energy production
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 ingredients on energy production.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen consumption
Key secondary outcomes
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the test foods A and training (6 weeks)
Interventions/Control_2
Intake of the test foods B and training (6 weeks)
Interventions/Control_3
Intake of the test foods C and training (6 weeks)
Interventions/Control_4
Intake of the control foods and training (6 weeks)
Interventions/Control_5
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Men aged 20 to 39 years.
2) Person who has a certain grip strength
3) Person who can come to the medical and inspection organizations for the measurement at the date of visiting.
4) Person who can understand the purpose and content of this study and agree in writing to participate in this study.
Key exclusion criteria
1) Person who has difficulty in implementation of exercise tolerance test.
2) Person whose gets high-intensity exercise on a daily basis
3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
4) Presence of previous and present disease such as chronic fatigue syndrome, sleep apnea syndrome, menopause, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
5) Investigator's judgment for other reason.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Ono |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho,Soraku-gun, Kyoto.
TEL
050-3182-0627
Yoshiko_Toyoda@suntory.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Takemoto |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho,Soraku-gun, Kyoto.
TEL
050-3182-0661
Homepage URL
Daisuke_Takemoto@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
None
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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6 Higashiueno, Taito-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.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 | 03 | Month | 30 | 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
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043542
