UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045301 |
|---|---|
| Receipt number | R000051340 |
| Scientific Title | Effects of functional food ingestion on glucose metabolism and intestinal microbiota |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2024/03/09 10:29:15 |
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Basic information
Public title
Effects of functional food ingestion on glucose metabolism and intestinal microbiota
Acronym
Effects of functional food ingestion on glucose metabolism and intestinal microbiota
Scientific Title
Effects of functional food ingestion on glucose metabolism and intestinal microbiota
Scientific Title:Acronym
Effects of functional food ingestion on glucose metabolism and intestinal microbiota
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 food intake on glucose metabolism and the intestinal microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentrations of blood glucose
Key secondary outcomes
The concentrations of insulin, GLP-1, GIP-1
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Acute ingestion of functional food (Morning trial)
Interventions/Control_2
Acute ingestion of functional food (evening trial)
Interventions/Control_3
Acute ingestion of placebo beverage (Morning trial)
Interventions/Control_4
Acute ingestion of placebo beverage (Evening trial)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20 yeras-old <=, 80 yeras-old >
Obtained written informed consent from the participant before participation.
Key exclusion criteria
1)individuals who are diagnosed with diabetes or dyslipidaemia, 2)taking any antioxidant, anti-obesity, or antidiabetes medication and supplements, 3)individuals who are using depression, sleeping, steroid medications, 4)individuals who are obese (BMI>35kg/m2), or who suffered from sleep apnea, 5)smoker, 6)individuals who are set pacemaker and metal in body (excluding dental filling), 7)individuals who are engaged shift work and travel with jetlag within 2 weeks.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro-ku, Tokyo, 152-8550
TEL
03-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro-ku, Tokyo, 152-8550
TEL
03-5734-2904
Homepage URL
takahashi.m.bp@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Institute of Technology
Address
2-12-1, Ookayama Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.ac.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
| 2021 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41430-023-01259-x
Publication of results
Partially published
Result
URL related to results and publications
https://www.nature.com/articles/s41430-023-01259-x
Number of participants that the trial has enrolled
12
Results
The incremental area under the blood glucose curve (iAUC) in the EM trials was significantly lower than that in the EP trials. The postprandial glucose concentrations 120 min after the meal were significantly lower in the EM trials than those in the EP trials.
Results date posted
| 2024 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1) diagnosed with diabetes or dyslipidaemia; (2) taking any antioxidant, anti-obesity, or antidiabetic medication or supplements; (3) taking depression, sleeping, or steroid medications; (4) obese (body mass index [BMI] > 35 kg/m2) or suffering from sleep apnoea; (5) smoker; (6) set pacemaker or metal in the body (excluding dental fillings); and (7) engaged in shift-work or travel with jetlag within the previous 2 weeks.
Participant flow
Open recruitment
Adverse events
None
Outcome measures
Glucose, insulin, GIP, GLP-1, TG, FFA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051340
