UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053113 |
|---|---|
| Receipt number | R000060612 |
| Scientific Title | Effects of consumption of the test food on reduction of post-exercise fatigue and improvement of lipid metabolism.: a randomized, placebo-controlled, double-blind, parallel-group study |
| Date of disclosure of the study information | 2024/12/15 |
| Last modified on | 2026/01/05 16:54:37 |
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Basic information
Public title
Effects of consumption of the test food on reduction of post-exercise fatigue and improvement of lipid metabolism.
Acronym
Effects of consumption of the test food on reduction of post-exercise fatigue and improvement of lipid metabolism.
Scientific Title
Effects of consumption of the test food on reduction of post-exercise fatigue and improvement of lipid metabolism.: a randomized, placebo-controlled, double-blind, parallel-group study
Scientific Title:Acronym
Effects of consumption of the test food on reduction of post-exercise fatigue and improvement of lipid metabolism.
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on reduction of post-exercise fatigue and improvement of lipid metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The feeling of general fatigue measured by visual analog scale (VAS)
Key secondary outcomes
1. The feeling of mental fatigue, physical fatigue, relief from fatigue, brain rotation, concentration, motivation, mood, irritability, and lightness of the body measured by visual analog scale (VAS)
2. VO2, VCO2, RQ, REE/min, REE/day, METS during exercise loading
3. POMS2 shortened version
4. salivary cortisol
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food (high dose) for 12 weeks
Interventions/Control_2
Intake of test food (low dose) for 12 weeks
Interventions/Control_3
Intake of placebo for 12 weeks
Interventions/Control_4
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese men and women whose age at the time of obtaining consent is 20 to 64 years old
2. Subjects who can exercise on a bicycle on an ergometer for about 50 minutes
3. Healthy Subjects
Key exclusion criteria
1. Subjects who consume drinks/supplements rich in proteins, peptides, and amino acids, foods for specified health uses, foods with functional claims, and health foods at least twice a week.
2. Subjects who have currently being treated for or have a history of chronic fatigue syndrome
3. Subjects who have been diagnosed with heart disease or an abnormality in cardiopulmonary function (e.g. arrhythmia) during a health checkup.
4. Subjects who are athletes and competitors
5. Subjects who are pregnant or may be pregnant, and those who are breastfeeding
6. Subjects who are alcoholic
7. Subjects who may have allergic reactions due to the ingredients of the test product
8. Subjects who participate in other clinical trials
9. Subjects who have chronic diseases or disorders of the liver, biliary tract, digestive system, circulatory system, respiratory system, kidneys, urinary system, psychiatry, nervous system, or blood system.
10. Subjects who have severe anemia
11. Subjects who go to the hospital / taking medication / obtaining treatment
12. Subjects who don't like bitter flavors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
| 2024 | Year | 12 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 11 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060612
