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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023792
Receipt No. 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

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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
Last 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
Email mhiguchi@waseda.jp

Public contact
1st 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
Email maruto7691@moegi.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027413

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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