UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041217
Receipt No. R000047032
Scientific Title Anabolic Micronutrients-Rich Foods Support Resistance Training-Induced Adaptation
Date of disclosure of the study information 2022/01/01
Last modified on 2020/07/27 (Ver. 1)

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Basic information
Public title Anabolic Micronutrients-Rich Foods Support Resistance Training-Induced Adaptation
Acronym Anabolic Micronutrients-Rich Foods Support Resistance Training-Induced Adaptation
Scientific Title Anabolic Micronutrients-Rich Foods Support Resistance Training-Induced Adaptation
Scientific Title:Acronym Anabolic Micronutrients-Rich Foods Support Resistance Training-Induced Adaptation
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of anabolic antioxidant rich foods on resistance exercise training-induced skeletal muscle adaptation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Compare the changes in resistance exercise training-induced muscle muscle mass and strength before and after the intervention in the intervention and non-intervention groups.
Key secondary outcomes Compare the changes in resistance exercise training-induced metabolism, oxidative stress, subjective fatigue before and after the intervention in the intervention and non-intervention groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Provided foods rich in antioxidants and instructed to take them actively for 10 weeks.
Interventions/Control_2 Non-ingestion
Interventions/Control_3
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
20 years-old <
Age-upper limit
30 years-old >=
Gender Male
Key inclusion criteria Healthy adult, men, non habitual exercise, non-smokers
Key exclusion criteria Subjects using vitamins, nourishing tonics, herbal medicines, general cold remedies, etc.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Wataru
Middle name
Last name Aoi
Organization Kyoto Prefectural University
Division name Division of Applied Life Sciences, Graduate School of Life and Environmental Sciences
Zip code 606-8522
Address 1-5 Hangi-cho Shimogamo, Sakyo-ku, Kyoto 606-8522, Japan
TEL 0757035417
Email waoi@kpu.ac.jp

Public contact
Name of contact person
1st name Wataru
Middle name
Last name Aoi
Organization Kyoto Prefectural University
Division name Division of Applied Life Sciences, Graduate School of Life and Environmental Sciences
Zip code 606-8522
Address 1-5 Hangi-cho Shimogamo, Sakyo-ku, Kyoto 606-8522, Japan
TEL 0757035417
Homepage URL
Email waoi@kpu.ac.jp

Sponsor
Institute Kyoto Prefectural University, Division of Applied Life Sciences, Graduate School of Life and Environmental Sciences
Institute
Department

Funding Source
Organization Non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University
Address 1-5 Hangi-cho Shimogamo, Sakyo-ku, Kyoto 606-8522, Japan
Tel 0757035417
Email waoi@kpu.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 京都府立大学（京都府）

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 26
Results 
Intake of antioxidants-contained foods may promote resistance training-induced muscle adaptation by reducing fatigue and increasing muscle strength.
Results date posted
2020 Year 07 Month 22 Day
Results Delayed
Delay expected
Results Delay Reason It takes time to analyze the data
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 04 Month 01 Day
Date of IRB
2016 Year 04 Month 27 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 27 Day
Last modified on
2020 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047032