UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032858 |
|---|---|
| Receipt number | R000037439 |
| Scientific Title | 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 | 2020/06/04 11:36:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hk.kim@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037439
