UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020459 |
|---|---|
| Receipt number | 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 10:44:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
fujino@phoenix.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University graduate School of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023638
