UMIN-CTR Clinical Trial

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	-
Email	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
Email	khadijachekima@gmail.com

Sponsor
Institute	Taylor's University
Institute
Department

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	-
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051811