UMIN-CTR Clinical Trial

Basic information
Public title	Effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level
Acronym	Effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level
Scientific Title	Effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level
Scientific Title:Acronym	Effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The following measures would be conducted before and after 2 weeks of intervention. 1)gut microbiota and glucose
Key secondary outcomes	1)hormone, inflammatory cytokines, bone metabolism markers 2)physical function parameter 3)physical activity (accelerometer) 4)morningness-eveningness type, Pittsburgh sleep quality index (questionnaire)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	10
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Breakfast (0800 - 1000) and Dinner (1800 - 2000): intake of A 5-10 g/meal for 1 week
Interventions/Control_2	Lunch (1200 - 1400) and Dinner (1800 - 2000): intake of A 5-10 g/meal for 1 week
Interventions/Control_3	Breakfast (0800 - 1000) and Dinner (1800 - 2000): intake of B 5-10 g/meal for 1 week
Interventions/Control_4	Lunch (1200 - 1400) and Dinner (1800 - 2000): intake of B 5-10 g/meal for 1 week
Interventions/Control_5	Breakfast (0800 - 1000) and Dinner (1800 - 2000): intake of C 5-10 g/meal for 1 week
Interventions/Control_6	Lunch (1200 - 1400) and Dinner (1800 - 2000): intake of C 5-10 g/meal for 1 week
Interventions/Control_7	Breakfast (0800 - 1000) and Dinner (1800 - 2000): intake of D 5-10 g/meal for 1 week
Interventions/Control_8	Lunch (1200 - 1400) and Dinner (1800 - 2000): intake of D 5-10 g/meal for 1 week
Interventions/Control_9	Breakfast (0800 - 1000) and Dinner (1800 - 2000): intake of E 5-10 g/meal for 1 week
Interventions/Control_10	Lunch (1200 - 1400) and Dinner (1800 - 2000): intake of E 5-10 g/meal for 1 week

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	89 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Gives informed consent, agrees to be randomly assigned
Key exclusion criteria	1) Physically active lifestyle 2) Intake of lipid and/or glucose lowering medication 3) Intake of Antipsychotics, Hypnotic, Steroids 4) Xylocaine allergy 5) Judged ineligible by a medical doctor. 6) Obesity (BMI>34kg/m2) and sleep apnea syndrome 7) High blood pressure (SBP: above 140mmHg, and DBP: above 90mmHg)
Target sample size	330

Research contact person
Name of lead principal investigator	1st name Shigenobu Middle name Last name Shibata
Organization	Waseda University
Division name	Faculty of Science and Engineering
Zip code	162-8480
Address	2-2 Wakamatsu, Shinjuku, Tokyo
TEL	03-5369-7318
Email	shibatas@waseda.jp

Public contact
Name of contact person	1st name Hyeon-Ki Middle name Last name Kim
Organization	Waseda University
Division name	School of Advanced Science and Engineering
Zip code	162-8480
Address	2-2 Wakamatsu, Shinjuku, Tokyo
TEL	03-5369-7318
Homepage URL
Email	hk.kim@aoni.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Ministry of Agriculture Forestry and Fisheries
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Women's Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Waseda University
Address	1-104 Totsuka, Shinjuku, Tokyo
Tel	03-5272-4652
Email	rps-management@list.waseda.jp

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	2018 Year 06 Month 04 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	37
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	Completed
Date of protocol fixation	2018 Year 04 Month 10 Day
Date of IRB	2018 Year 06 Month 08 Day
Anticipated trial start date	2018 Year 06 Month 04 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Interventions_11: Control group

Management information
Registered date	2018 Year 06 Month 04 Day
Last modified on	2020 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037439