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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032858
Receipt No. R000037439
Official scientific title of the study Effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level
Date of disclosure of the study information 2018/06/04
Last modified on 2018/12/04

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Basic information
Official scientific title of the study Effect of different intake time of functional food ingredients on gut microbiota and diurnal rhythm of glucose level
Title of the study (Brief title) 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 Shigenobu Shibata
Organization Waseda University
Division name Faculty of Science and Engineering
Address 2-2 Wakamatsu, Shinjuku, Tokyo
TEL 03-5369-7318
Email shibatas@waseda.jp

Public contact
Name of contact person Hyeon-Ki Kim
Organization Waseda University
Division name Organization for University Research Initiatives
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 10 Day
Anticipated trial start date
2018 Year 06 Month 04 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 Interventions_11: Control group

Management information
Registered date
2018 Year 06 Month 04 Day
Last modified on
2018 Year 12 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

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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