UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029193