- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05336032
Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults
Evidence has./ indicated increased risk of type 2 diabetes with white rice consumption in Asian population. It is shown that glycemic response to carbohydrate-containing food may differ in people of different ethnicities. The large increment in glucose concentration induced by high glycemic index food often exaggerates the body's anabolic responses, which facilitates the overproduction of insulin and eventually results in pancreatic beta-cell failure, causing type 2 diabetes mellitus.
Given that rice is the staple food of Asians and Emiratis, and extent to which rice influences postprandial glycemia could have potential relevance in the prevention and treatment of diabetes.
In this study, the investigators intend to compare the glycemic and hunger satiety response to rice among overweight Emiratis, Asians, and Caucasian. The primary objective of the study is to compare the glycemic (glucose) and hunger satiety (hormone ghrelin and peptide YY) response to glucose and rice among overweight Emiratis, Asians, and Caucasians.
Study Overview
Detailed Description
An increased incidence of type 2 diabetes is a characteristic feature of populations that have undergone nutritional transition. First seen in the developed Western world, the same pattern is now being observed in Middle East and Asian countries, and United Arab Emirates (UAE) is one of them. Although overconsumption of energy and accumulation of excess body fat is a common cause of type 2 diabetes, diet almost certainly has other unknown effects, and specific foods with particular adverse effects may have a direct role in the development of type 2 diabetes. Recent meta-analysis and systematic reviews have indicated increased risk of type 2 diabetes with white rice consumption in Asian population. It is shown that glycemic response to carbohydrate-containing food may differ in people of different ethnicities. Previous studies have shown that identical carbohydrate loads elicit 2-3 times larger postprandial peaks in Asians compared to Caucasians. Although there are comparative studies reported in this region. The large increment in glucose concentration induced by high glycemic index food often exaggerates the body's anabolic responses, which facilitates the overproduction of insulin and eventually results in pancreatic beta-cell failure, causing type 2 diabetes mellitus.
Given that rice is the staple food of Asians and Emiratis, and extent to which rice influences postprandial glycemia could have potential relevance in the prevention and treatment of diabetes.
In this study, the investigators intend to compare the glycemic and hunger satiety response to rice among overweight Emiratis, Indian, and Caucasian.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sadiya
- Phone Number: 00971637147345
- Email: sadiya.amena@gmail.com
Study Contact Backup
- Name: Jakapure
- Phone Number: 00971637147387
- Email: vidya.jakapure@skmca.ae
Study Locations
-
-
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Ajman, United Arab Emirates
- Recruiting
- Rashid Centre for Diabetes and Research
-
Contact:
- Amena Sadiya, PhD
- Phone Number: +97167147345
- Email: sadiya.amena@gmail.com
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Principal Investigator:
- Amena Sadiya, Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants willing to comply with study procedures and given written consent
- Asian/Emirati/European ethnicity (both parents same ethnicity)
- Body mass index between 24.9-29.9 kg/m2
- Age 18-55 years
- Fasting blood glucose <6.0 mmol/L
Exclusion Criteria:
• Subjects with chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, post bariatric, known eating disorders
- Use of medication affecting glucose metabolism
- Recent changes in weight of > 5 % ove the past 3 months
- On antibiotics for the past 3 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Oral glucose tolerance test
The volunteer will be performing the standardized oral glucose tolerance test with 75 gm of glucose.
After an overnight fast of 10 hours the venous blood will be collected at fasting, 30, 60 and 120 minutes post-prandial and hunger-satiety scale recorded at the same interval.
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Cooked rice with 75 gm carbohydrate
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Experimental: Post prandial response to Rice
The participants will be served cooked basmati rice (70-gram available glucose).
After an overnight fast of 10 hours the venous blood will be collected at fasting, 30, 60 and 120 minutes post-prandial and hunger-satiety scale recorded at the same interval.
|
Cooked rice with 75 gm carbohydrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the post prandial glucose response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults
Time Frame: 2 hours
|
post prandial glucose response at baseline, 30, 60, 120 minutes, oral glucose tolerance test (75 gm glucose) Vs. post prandial glucose response to rice test (75 gm available glucose)
|
2 hours
|
|
To compare the post prandial insulin response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults
Time Frame: 2 hours
|
post prandial insulin response at baseline, 30, 60, 120 minutes, oral glucose tolerance test (75 gm glucose) Vs. post prandial insulin response to rice test (75 gm available glucose)
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the post prandial hunger (ghrelin hormone) to oral glucose and rice among Asian, Emirati and European Caucasian overweight adults
Time Frame: 2 hours
|
post prandial ghrelin hormone response at baseline, 30, 60, 120 minutes, with oral glucose tolerance test (75 gm glucose) Vs. post prandial ghrelin hormone response to rice test (75 gm available glucose)
|
2 hours
|
|
To compare the post prandial satiety (peptide-yy hormone) to oral glucose and rice among Asian, Emirati and European Caucasian overweight adults
Time Frame: 2 hours
|
post prandial peptide -yy hormone response at baseline, 30, 60, 120 minutes, with oral glucose tolerance test (75 gm glucose) Vs. post prandial peptide-yy hormone response to rice test (75 gm available glucose)
|
2 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKMCA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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