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

-

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 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

-

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051811


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name