UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045385 |
|---|---|
| Receipt number | R000051811 |
| Scientific Title | Glycemic index determination of mixed meals by continuous glucose monitoring, their effect on daily glucose profile and carbohydrate preference among overweight and obese young adults |
| Date of disclosure of the study information | 2021/09/05 |
| Last modified on | 2021/09/05 12:24:51 |
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Basic information
Public title
Glycemic index determination of mixed meals by continuous glucose monitoring, their effect on daily glucose profile and carbohydrate preference among overweight and obese young adults
Acronym
Glycemic index determination of mixed meals by continuous glucose monitoring, their effect on daily glucose profile and carbohydrate preference
Scientific Title
Glycemic index determination of mixed meals by continuous glucose monitoring, their effect on daily glucose profile and carbohydrate preference among overweight and obese young adults
Scientific Title:Acronym
Glycemic index determination of mixed meals by continuous glucose monitoring, their effect on daily glucose profile and carbohydrate preference
Region
| Asia(except Japan) |
Condition
Condition
overweight and obesity
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To determine the GI of mixed meals consisting of three varieties of commonly consumed rice in several Southeast Asian countries using rtCGM and their effect on the 24h glucose profile of overweight and obese young adults.
2)To determine the influence of participants knowledge of postprandial glucose data generated by rtGCM has on their preference for different rice varieties
Basic objectives2
Others
Basic objectives -Others
1) To determine the GI of mixed meals consisting of three varieties of commonly consumed rice in several Southeast Asian countries using rtCGM and their effect on the 24h glucose profile of overweight and obese young adults.
2)To determine the influence of participants knowledge of postprandial glucose data generated by rtGCM has on their preference for dfferent rice varieties
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic index of mixed meals measured using rtCGM
Key secondary outcomes
Glycemic variability ( GV), 24h mean glucose level, 24h glucose target ranges, carbohydrate preference
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
Control (50g glucose solution)
Interventions/Control_2
White rice mixed meal
Interventions/Control_3
Brown rice mixed meal
Interventions/Control_4
Parboiled basmati rice mixed meal
Interventions/Control_5
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Overweight or obese individuals (BMI >= 25 kg/m2)
2. Age of 18 to 35 years old
3. Non-smoking
4. Non-alcoholic
5. Stable body weight (plus minus 3 kg) for the past 3 months
6. Normal fasting blood glucose (< 5.6 mmol/L)
Key exclusion criteria
1. Pregnant or lactating women
2. Following a vigorous weight loss regimen
3. Diabetic
4. Suffering from hepatic or renal dysfunction
5. Taking medication or supplementation that affects appetite or food intake
6. Using medication that may affect glucose metabolism (eg. corticoids, thyroid hormones, and thiazide diuretics)
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Tziak Ze |
| Middle name | |
| Last name | Wong |
Organization
Taylor's University
Division name
School of Food Studies & Gastronomy
Zip code
47500
Address
Taylor's University No.1, Jalan Taylors, 47500, Subang Jaya, Selangor, Malaysia
TEL
-
TziakZe.Wong@taylors.edu.my
Public contact
Name of contact person
| 1st name | Khadidja |
| Middle name | |
| Last name | Chekima |
Organization
Taylor's University
Division name
School of Biosciences, Faculty of Health and Medical Sciences
Zip code
47500
Address
Taylor's University, No.1, Jalan Taylors, 47500, Subang Jaya, Selangor, Malaysia
TEL
-
Homepage URL
khadijachekima@gmail.com
Sponsor or person
Institute
Taylor's University
Institute
Department
Personal name
Funding Source
Organization
Taylor's 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
Taylor's University Human Ethics Committee
Address
Taylor's University No.1, Jalan Taylors, 47500 Subang Jaya, Selangor, Malaysia
Tel
-
tuec@taylors.edu.my
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
Taylor's University, Malaysia
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 05 | 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
15
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
| 2019 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 28 | 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 | 09 | Month | 05 | Day |
Last modified on
| 2021 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051811
