UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048721 |
|---|---|
| Receipt number | R000055494 |
| Scientific Title | Effect of legumes consumed with carbohydrates on blood glucose levels |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2025/01/16 11:09:57 |
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Basic information
Public title
Effect of legumes consumed with carbohydrates on blood glucose levels
Acronym
Effect of legumes consumed with carbohydrates on blood glucose levels
Scientific Title
Effect of legumes consumed with carbohydrates on blood glucose levels
Scientific Title:Acronym
Effect of legumes consumed with carbohydrates on blood glucose levels
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the consumption of legumes along with carbohydrates affects blood glucose levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial blood glucose levels
Key secondary outcomes
1. number of chews
2. sensory evaluation
3. questionnaire survey
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of rice with cooked bean (yellow soybeans)
Interventions/Control_2
Single intake of rice with cooked bean (black soybeans, small)
Interventions/Control_3
Single intake of rice with cooked bean (black soybeans, large)
Interventions/Control_4
Single intake of rice with cooked bean (cowpeas)
Interventions/Control_5
Single intake of rice
Interventions/Control_6
Single intake of rice with indigestible dextrin
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
Female
Key inclusion criteria
1. Healthy females aged between the ages of 20 and 40
2. Subjects who are capable of understanding the study, and those who can give written informed consents
Key exclusion criteria
1. Subjects who are allergic to products related to the test material (rice and beans such as soybean) of this study
2. Subjects who take drugs, quasi-drugs, dietary supplements, health foods or something other which possibly have effects on this study
3. Subjects currently undergoing treatment for any of the following chronic disease: diabetes mellitus, and hypertension
4. Scheduled for surgery
5. Subjects who are pregnant or breastfeeding, or desires to get pregnant during the study period
6. Withdrawal of consent
7. Fasting blood glucose levels >126 mg/dL
8. Tendency to hemorrhage
9. Subjects who are judged unsuitable for this study by principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Oki |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
tomooki@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Oki |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
Homepage URL
tomooki@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Nakamura Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nakamura Gakuen University Ethics Review Committee
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
Tel
092-851-2531
kks@nakamura-u.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
中村学園大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055494
