NCT05336032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

March 25, 2022

Last Update Submit

October 24, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    2 hours

  • 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)

    2 hours

Secondary Outcomes (2)

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

    2 hours

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

    2 hours

Study Arms (2)

Oral glucose tolerance test

ACTIVE COMPARATOR

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.

Other: Food (rice)

Post prandial response to Rice

EXPERIMENTAL

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.

Other: Food (rice)

Interventions

Cooked rice with 75 gm carbohydrate

Oral glucose tolerance testPost prandial response to Rice

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rashid Centre for Diabetes and Research

Ajman, United Arab Emirates

RECRUITING

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager Dietetics

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 20, 2022

Study Start

April 1, 2022

Primary Completion

August 30, 2022

Study Completion

October 30, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations