UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025360 |
|---|---|
| Receipt number | R000029193 |
| Scientific Title | Effect of carbohydrate intake after endurance exercise on various leukocyte counts and activation during recovery period. |
| Date of disclosure of the study information | 2016/12/21 |
| Last modified on | 2022/06/25 09:34:22 |
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Basic information
Public title
Effect of carbohydrate intake after endurance exercise on various leukocyte counts and activation during recovery period.
Acronym
Carbohydrate intake after endurance exercise and leukocyte counts and activation.
Scientific Title
Effect of carbohydrate intake after endurance exercise on various leukocyte counts and activation during recovery period.
Scientific Title:Acronym
Carbohydrate intake after endurance exercise and leukocyte counts and activation.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of carbohydrate intake after endurance exercise on various leukocyte counts and activation during recovery period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Leukocyte counts/fraction, Interleukin 6 (IL-6), Interleukin 8 (IL-8), monocyte chemoattractant protein-1 (MCP-1), Myeloperoxidase, Calprotectin, granulocyte-colony stimulating factor (G-CSF), elastase
Key secondary outcomes
Plasma glucose, insulin, free fatty acid, myoglobin, creatine kinase, Aldorase, catecholamine, cortisol, growth hormone, red blood cell counts, hemoglobin, hematocrit
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Period: 3 days
Day 1: Ingestion of carbohydrate solution including 0.8 g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 2: Ingestion of carbohydrate solution including 0.13g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 3: Ingestion of placebo solution 3 times every 30 minutes after 60 min cycling exercise.
Interventions/Control_2
Period: 3 days
Day 1: Ingestion of carbohydrate solution including 0.8 g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 2: Ingestion of placebo solution 3 times every 30 minutes after 60 min cycling exercise.
Day 3: Ingestion of carbohydrate solution including 0.13g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Interventions/Control_3
Period: 3 days
Day 1: Ingestion of carbohydrate solution including 0.13 g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 2: Ingestion of carbohydrate solution including 0.8g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 3: Ingestion of placebo solution 3 times every 30 minutes after 60 min cycling exercise.
Interventions/Control_4
Period: 3 days
Day 1: Ingestion of carbohydrate solution including 0.13 g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 2: Ingestion of placebo solution 3 times every 30 minutes after 60 min cycling exercise.
Day 3: Ingestion of carbohydrate solution including 0.8g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Interventions/Control_5
Day 1: Ingestion of placebo solution 3 times every 30 minutes after 60 min cycling exercise.
Day 2: Ingestion of carbohydrate solution including 0.8 g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 3: Ingestion of carbohydrate solution including 0.13g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Interventions/Control_6
Day 1: Ingestion of placebo solution 3 times every 30 minutes after 60 min cycling exercise.
Day 2: Ingestion of carbohydrate solution including 0.13 g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Day 3: Ingestion of carbohydrate solution including 0.8g/body weight of glucose + maltodextrin 3 times every 30 minutes after 60 min cycling exercise.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy men who give informed consent.
Key exclusion criteria
Physician has placed a restriction o physical exercise.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Higuchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
04-2947-6745
mhiguchi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumpei Tanisawa |
Organization
Waseda University
Division name
Waseda Institute for Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
04-2947-6833
Homepage URL
k.tanisawa3@kurenai.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Asashi Soft Drinks 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
Address
Tel
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
| 2016 | Year | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 09 | 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
| 2016 | Year | 12 | Month | 21 | Day |
Last modified on
| 2022 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029193
