UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054832 |
|---|---|
| Receipt number | R000062655 |
| Scientific Title | Investigation of the effect of pre-meal consumption of plant-based dairy drinks on postprandial glucose levels. |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2024/07/01 13:31:34 |
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Basic information
Public title
Investigation of the effect of pre-meal consumption of plant-based dairy drinks on postprandial glucose levels.
Acronym
Investigation of the effect of pre-meal consumption of plant-based dairy drinks on postprandial glucose levels.
Scientific Title
Investigation of the effect of pre-meal consumption of plant-based dairy drinks on postprandial glucose levels.
Scientific Title:Acronym
Investigation of the effect of pre-meal consumption of plant-based dairy drinks on postprandial glucose levels.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effects of pre-meal consumption of plant-based dairy drinks on postprandial glucose levels on the basis of chrono-nutrition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of plant-based dairy drink 60 minutes before a meal.
Interventions/Control_2
Ingestion of plant-based dairy drink 30 minutes before a meal.
Interventions/Control_3
Ingestion of plant-based dairy drink 15 minutes before a meal.
Interventions/Control_4
Ingestion of plant-based dairy drink immediately before a meal.
Interventions/Control_5
No ingestion of plant-based dairy drink.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) healthy individuals aged 18 years and older.
(2) individuals who provided written consent for participation.
Key exclusion criteria
(1) individuals who were allergic to the food used in the study
(2) individuals with glucose intolerance (abnormal at medical examination for the past 2 years)
(3) individuals with a fasting blood glucose of >110 mg/dL
(4) individuals with a Body Mass Index (BMI) of >30
(5) patients with severe liver disease, kidney disease, heart disease, lung disease, psychiatric disease, blood disease, etc.
(6) individuals who took drugs such as antihypertensive drugs
(7) those who wished to become pregnant, or were pregnant/breastfeeding during the study
(8) those who were judged by the study supervisor to be inappropriate for participation.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1338585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
furutani@aikoku-jc.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Furutani |
Organization
Aikoku Gakuen Junior College
Division name
Department of Home Economics
Zip code
1338585
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
TEL
03-5668-7260
Homepage URL
furutani@aikoku-jc.ac.jp
Sponsor or person
Institute
Aikoku Gakuen Junior College
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aikoku Gakuen Junior College
Address
5-7-1, Nishikoiwa, Edogawa-ku, Tokyo
Tel
03-5668-7260
aioffice@aikoku-jc.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
| 2024 | Year | 07 | Month | 03 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062655
