UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023792 |
|---|---|
| Receipt number | R000027413 |
| Scientific Title | Effects of timing of functional foods intake on health-related parameters in elderly people |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/08/27 21:02:35 |
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Basic information
Public title
Effects of timing of functional foods intake on health-related parameters in elderly people
Acronym
Effects of timing of functional foods intake on health-related parameters in elderly people
Scientific Title
Effects of timing of functional foods intake on health-related parameters in elderly people
Scientific Title:Acronym
Effects of timing of functional foods intake on health-related parameters in elderly people
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effects of timing of functional foods intake on health-related parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density
Key secondary outcomes
Gut microbiota, the concentrations of blood glucose, insulin, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides, handgrip strength, gait speed, skeletal muscle mass index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Inulin (Morning trial)
Period: 12 weeks
Dose: 5g inulin
Interventions/Control_2
Inulin (Evening trial)
Period: 12 weeks
Dose: 5g inulin
Interventions/Control_3
Placebo (Morning trial)
Period: 12 weeks
Dose: 2.5g carbohydrate
Interventions/Control_4
Placebo (Evening trial)
Period: 12 weeks
Dose: 2.5g carbohydrate
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
60 years-old <=, 80 years-old >
Gives informed consent, agrees to be randomly assigned
Key exclusion criteria
1. History or presence of diabetes, heart disease, liver disease and kidney disease, stroke, osteoporosis and alzheimer disease.
2. Physician has placed a restriction on physical exercise.
Target sample size
60
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
+81-4-2947-6745
mhiguchi@waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Ito |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
+81-4-2947-6833
Homepage URL
maruto7691@moegi.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program
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 | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | 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 | 08 | Month | 27 | Day |
Last modified on
| 2016 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027413
