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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020459
Receipt No. R000023638
Scientific Title Study of the effects of anti-oxidant supplementation on fatigability in healthy elderly
Date of disclosure of the study information 2016/01/06
Last modified on 2017/07/14

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Basic information
Public title Study of the effects of anti-oxidant supplementation on fatigability in healthy elderly
Acronym Effects of anti-oxidant supplementation
Scientific Title Study of the effects of anti-oxidant supplementation on fatigability in healthy elderly
Scientific Title:Acronym Effects of anti-oxidant supplementation
Region
Japan

Condition
Condition fatigability,Sarcopenia
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To study efficacy of anti-oxidant supplementation on fatigability in healthy elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes walking distance for 6-minutes
hemodynamics
oxidative stress
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 anti-oxidant supplementation, 3-month, 2 times per day
Interventions/Control_2 placebo, 3-month, 2 times per day
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria subjects who can walk
Key exclusion criteria 1)Subjects who have previous medical history of drug and/or food allergy.
2)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., diabetes, digestive organ, liver, pancreas, heart and/or kidney).
3)Subjects who have been enrolled in the other clinical trials within about last 1 month.
4)Subjects who predicted gluttony and irregular eating habits by the pre-questionnaire and doctor's questions.
5)Subjects who constantly use supplements and/or functional foods affecting fatigability.
6)Subjects who take medicines and plan to take new health foods.
7)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Fujino
Organization Kobe University graduate School of Health Sciences
Division name Rehabilitation Science
Zip code
Address 7-10-2 Tomogaoka, Kobe
TEL 078-796-4542
Email fujino@phoenix.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidemi Fujino
Organization Kobe University graduate School of Health Sciences
Division name Rehabilitation Science
Zip code
Address 7-10-2 Tomogaoka, Kobe
TEL 078-796-4542
Homepage URL
Email fujino@phoenix.kobe-u.ac.jp

Sponsor
Institute Kobe University graduate School of Health Sciences
Institute
Department

Funding Source
Organization Kobe University graduate School of Health Sciences
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
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 01 Month 06 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 Enrolling by invitation
Date of protocol fixation
2016 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 06 Day
Last follow-up date
2017 Year 03 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
2016 Year 01 Month 06 Day
Last modified on
2017 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023638

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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