UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051030 |
|---|---|
| Receipt number | R000058158 |
| Scientific Title | The effects of peptide on fatigue decreasing after exercise loading: A randomized, double-blind, placebo-controlled, crossover study |
| Date of disclosure of the study information | 2023/05/12 |
| Last modified on | 2023/05/10 10:58:37 |
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Basic information
Public title
The effects of peptide on fatigue decreasing after exercise loading: A randomized, double-blind, placebo-controlled, crossover study
Acronym
The effects of peptide on fatigue decreasing after exercise loading: A randomized, double-blind, placebo-controlled, crossover study
Scientific Title
The effects of peptide on fatigue decreasing after exercise loading: A randomized, double-blind, placebo-controlled, crossover study
Scientific Title:Acronym
The effects of peptide on fatigue decreasing after exercise loading: A randomized, double-blind, placebo-controlled, crossover study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of peptide on fatigue after exercise loading.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective fatigue (Visual Analog Scale)
Key secondary outcomes
1.Blood lactate concentration
2.Subjective fatigue for three days after the exercise day (Visual Analog Scale)
3.Subjective exercise intensity (Borg Scale)
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food(high dose)
Interventions/Control_2
Single intake of test food(low dose)
Interventions/Control_3
Single intake of placebo food
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Subjects aged 18-64 years
Key exclusion criteria
1) Subjects who are under treatment or have a history of disorders such as cardiovascular, respiratory, or metabolic system.
2) Subjects who receive a drug treatment or physical therapy.
3) Subjects who have drug allergies or food allergies.
4) Subjects who regularly use food for specified health uses, functional foods, health foods whose affects this study.
5) Subjects who have smoking habit.
6) Subjects whose BMIs are >=30.
7) Subjects drink alcohol polydipsia (pure alcohol equivalent more than 60 g/day)
8) Subjects who participated in clinical trials of other drugs or foods within one month, or who plan to do just after giving informed consent.
9) Subjects who have been ordered not to do exercise by a medical doctor within a year.
10) Subjects who have not taken a medical examination within a year
11) Subjects who are judged inappropriate to this trial by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tanaka |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Innovative Research Institute, R&D Division
Zip code
252-8583
Address
5-1-83,Higashihara,Zama city, Kanagawa, Japan
TEL
046-252-3051
kiso-hcrsmng@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshitake |
Organization
Yamaguchi Health Lab.
Division name
General manager
Zip code
754-0041
Address
Medifit Lab 3F, 1-1-2, Ogorireiwa, Yamaguchi city, Yamaguchi Pref., Japan
TEL
083-976-4095
Homepage URL
info@yamaguchi-hl.com
Sponsor or person
Institute
Morinaga Milk Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., 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
Japan Conference of Clinical Research
Address
13-23, 1-Chome, Minami Ikebukuro, Toyoshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@jccr.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
| 2023 | Year | 05 | Month | 12 | 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 | 04 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | 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 | 05 | Month | 10 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058158
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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