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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025360
Receipt No. 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 2017/12/15

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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
Email 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
Email k.tanisawa3@kurenai.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 21 Day
Last follow-up date
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
2017 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029193

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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