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Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults

Primary Purpose

Glycemic Response

Status
Recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Food (rice)
Sponsored by
Rashid Centre for Diabetes and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glycemic Response

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rashid Centre for Diabetes and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral glucose tolerance test

Post prandial response to Rice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To compare the post prandial glucose response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults
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)
To compare the post prandial insulin response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults
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)

Secondary Outcome Measures

To compare the post prandial hunger (ghrelin hormone) to oral glucose and rice among Asian, Emirati and European Caucasian overweight adults
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)
To compare the post prandial satiety (peptide-yy hormone) to oral glucose and rice among Asian, Emirati and European Caucasian overweight adults
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)

Full Information

First Posted
March 25, 2022
Last Updated
October 24, 2022
Sponsor
Rashid Centre for Diabetes and Research
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1. Study Identification

Unique Protocol Identification Number
NCT05336032
Brief Title
Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults
Official Title
Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rashid Centre for Diabetes and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glycemic Response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral glucose tolerance test
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Post prandial response to Rice
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Food (rice)
Intervention Description
Cooked rice with 75 gm carbohydrate
Primary Outcome Measure Information:
Title
To compare the post prandial glucose response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults
Description
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)
Time Frame
2 hours
Title
To compare the post prandial insulin response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults
Description
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)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
To compare the post prandial hunger (ghrelin hormone) to oral glucose and rice among Asian, Emirati and European Caucasian overweight adults
Description
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)
Time Frame
2 hours
Title
To compare the post prandial satiety (peptide-yy hormone) to oral glucose and rice among Asian, Emirati and European Caucasian overweight adults
Description
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)
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sadiya
Phone
00971637147345
Email
sadiya.amena@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jakapure
Phone
00971637147387
Email
vidya.jakapure@skmca.ae
Facility Information:
Facility Name
Rashid Centre for Diabetes and Research
City
Ajman
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amena Sadiya, PhD
Phone
+97167147345
Email
sadiya.amena@gmail.com
First Name & Middle Initial & Last Name & Degree
Amena Sadiya, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults

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