UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044896 |
|---|---|
| Receipt number | R000050587 |
| Scientific Title | Effects of two months of lactotripeptide (LTP) intake and aerobic exercise intervention on fatigue, vascular function and exercise capacity: A randomized controlled trial |
| Date of disclosure of the study information | 2021/08/15 |
| Last modified on | 2022/08/02 11:57:42 |
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Basic information
Public title
Effects of two months of lactotripeptide (LTP) intake and aerobic exercise intervention on fatigue, vascular function and exercise capacity: A randomized controlled trial
Acronym
The effect of exercise training and lactotripeptides
Scientific Title
Effects of two months of lactotripeptide (LTP) intake and aerobic exercise intervention on fatigue, vascular function and exercise capacity: A randomized controlled trial
Scientific Title:Acronym
The effect of exercise training and lactotripeptides
Region
| Japan |
Condition
Condition
Middle-aged and older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of two months of lactotripeptide (LTP) intake and aerobic exercise intervention on fatigue, vascular function and exercise capacity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue (2 months after intervention)
Key secondary outcomes
Vascular function (2 months after intervention)
Aerobic capacity (2 months after intervention)
Physical performance (2 months after intervention)
Biochemical blood test (2 months after intervention)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Placebo (casein) ingestion, 2 months
Interventions/Control_2
Lactotripeptides ingestion, 2 months
Interventions/Control_3
Placebo (casein) ingestion, 2 months
Aerobic exercise (moderate intensity, 30-50 min, 3-6 d/w), 2 months
Interventions/Control_4
Lactotripeptides ingestion, 2 months
Aerobic exercise (moderate intensity, 30-50 min, 3-6 d/w), 2 months
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Not restricted by a doctor from exercising
2. Not doing moderate- to vigorous-intensity aerobic training
3. Not participate in another clinical trial in one year
4. Not have lactose intolerance
5. Can agree with contents of study
6. Not take angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker
Key exclusion criteria
1. Care-dependent or support-dependent on a Japanese long-term care insurance system
2. Have severe heart disease, cerebrovascular disease, and renal dysfunction
3. Medical doctors can not agree with participation in the study
4. Limited mobility
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Keisei |
| Middle name | |
| Last name | Kosaki |
Organization
University of Tsukuba
Division name
Factory of Health and Sports Science
Zip code
3058574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
kosaki.keisei.gm@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Yoshioka |
Organization
University of Tsukuba
Division name
Factory of Health and Sports Science
Zip code
3058574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
Homepage URL
masakiyoshioka1129@gmail.com
Sponsor or person
Institute
Factory of Health and Sports Science, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethcal committee of University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-29-853-2571
hitorinri@un.tsukuba.ac.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
筑波大学総合研究棟D
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
98
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
| 2021 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050587
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
