UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of timing of functional foods intake on health-related parameters in elderly people
Title of the study (Brief title)	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	Mitsuru Higuchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL	+81-4-2947-6745
Email	mhiguchi@waseda.jp

Public contact
Name of contact person	Tomoko Ito
Organization	Waseda University
Division name	Graduate School of Sport Sciences
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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