Glycemic ResponseNCT05336032
Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults
A study testing Food (rice) in people with Glycemic Response, run by Rashid Centre for Diabetes and Research at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response
- What is being tested?
- Food (rice)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Apr 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Rashid Centre for Diabetes and Research
Ajman
Amena Sadiya, PhD, +97167147345, sadiya.amena@gmail.com
Amena Sadiya, Ph.D
About this study
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.
Read the 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.
- Conditions
- Glycemic Response
- Being tested
- Food (rice)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food (rice)Other
Cooked rice with 75 gm carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Food (rice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
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)
Measured: 2 hours
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)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Aug 2022
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rashid Centre for Diabetes and Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Amena Sadiya, Rashid Centre for Diabetes and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336032
- Sponsor's protocol ID
- SKMCA
- Status last verified
- Oct 2022
- First submitted
- 25 Mar 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Variability in Glycemic and Hunger Satiety Response to Rice in Overweight Adults
- ClinicalTrials.gov ID
- NCT05336032
- Acronym / sponsor ID
- SKMCA
- Conditions
- Glycemic Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rashid Centre for Diabetes and ResearchUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral glucose tolerance test | Active comparator | Other: Food (rice)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. |
| Post prandial response to Rice | Experimental | Other: Food (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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants willing to comply with study procedures and given written consent
Key exclusion criteria (4 listed)
- • Subjects with chronic diseases, including diabetes, untreated hypertension, renal impairment, gastrointestinal problems, post bariatric, known eating disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food (rice)Cooked rice with 75 gm carbohydrate | Other | Oral glucose tolerance test, Post prandial response to Rice |
Primary outcome
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)
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 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food (rice) in people with Glycemic Response, run by Rashid Centre for Diabetes and Research at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sadiya (00971637147345, sadiya.amena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the post prandial glucose response to oral glucose and rice among Emiratis, Asians, and Caucasian overweight adults (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.