Postprandial HyperglycemiaNCT05878301
Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults
A study testing vegetable and protein first followed by carbohydrates (VPF) meal sequence in people with Postprandial Hyperglycemia, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
the goal of this Randomized controlled cross over trial is to compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- vegetable and protein first followed by carbohydrates (VPF) meal sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 9 Jun 2023to 14 Aug 2023
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria were age of 18-59 years
- Emirati, Gulf Cooperation Council (GCC), and Arabs ethnicity
- BMI: 18.5-29.9 kg/m2
- Fasting blood glucose level less than 100 mg/dL
- Non-smoker
- no genetic or metabolic diseases
- no known medical condition.
Who cannot join
- any participants with pre-existing diabetes
- Pregnant and breastfeeding women
- Participants with behaviors or/and health conditions that are known to affect glucose or -- insulin concentrations, such as smoking, gastrointestinal conditions, bariatric surgery, gastroparesis and reactive hypoglycemia
- Participants who consumed medication that might affect glucose or insulin response
- Participants with reported allergy or intolerance to any of the meal components (White Basmati rice, grilled chicken, cucumber, tomato, and lettuce salad with lemon olive oil dressing).
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Diabetes center ,university of sharjah
Sharjah city
About this study
Official title: Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults: A Randomized Controlled Crossover Trial
the goal of this Randomized controlled cross over trial is to compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE. the main question it aims to answer is what is the effect of meal sequence of vegetable and protein first followed by carbohydrates (VPF) compared to a standard mixed meal (SMM) on the postprandial glucose level and insulin response among healthy adults in the UAE. Participants will consume two is caloric test meals in random order (SMM and VPF meal sequences) separated by a 7-10-day washout period then blood sample will be collected at fasting ,30min,60min and 120mon for glucose and insulin and hunger ration will be done as well .Researchers will compare the effect of the two meals on postprandial blood glucose, insuline and hunger rating.
- Conditions
- Postprandial Hyperglycemia
- Being tested
- vegetable and protein first followed by carbohydrates (VPF) meal sequence
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegetable and protein first followed by carbohydrates (VPF) meal sequenceOther
Also called VPF
vegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence
| Study group | Role | What they receive |
|---|---|---|
| standard mixed meal (SMM) | Other | standard mixed meal (SMM) consumed within 15 min to compared to the vegetable protein first followed 10 min later by carbohydrates it with the effect on postprandial glucose ,insulin and hunger rating Receives: Other: vegetable and protein first followed by carbohydrates (VPF) meal sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE.
incremental area under the curve
Measured: 7-10 days
Secondary outcomes (2)
To compare the effects of the VPF meal sequence vs. SMM sequence on the incremental area under the curve of postprandial insulin response.
incremental area under the curve
Measured: 2 month
To compare the postprandial hunger response of the VPF meal sequence vs SMM sequence on the area under the curve using a validated visual analog scale for hunger and fullness (VAS)
]area under the curve
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start9 Jun 2023
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial HyperglycemiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayah Shaheen, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878301
- Sponsor's protocol ID
- REC-22-10-18-S
- Status last verified
- Aug 2023
- First submitted
- 17 May 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shukla AP, Andono J, Touhamy SH, Casper A, Iliescu RG, Mauer E, Shan Zhu Y, Ludwig DS, Aronne LJ. Carbohydrate-last meal pattern lowers postprandial glucose and insulin excursions in type 2 diabetes. BMJ Open Diabetes Res Care. 2017 Sep 14;5(1):e000440. doi: 10.1136/bmjdrc-2017-000440. eCollection 2017.
PubMed 28989726
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT05878301
- Acronym / sponsor ID
- REC-22-10-18-S
- Conditions
- Postprandial Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 26 May 2023 (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.
the goal of this Randomized controlled cross over trial is to compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE. the main question it aims to answer is what is the effect of meal sequence of vegetable and protein first followed by carbohydrates (VPF) compared to a standard mixed meal (SMM) on the postprandial glucose level and insulin response among healthy adults in the UAE. Participants will consume two is caloric test meals in random order (SMM and VPF meal sequences) separated by a 7-10-day washout period then blood sample will be collected at fasting ,30min,60min and 120mon for glucose and insulin and hunger ration will be done as well .Researchers will compare the effect of the two meals on postprandial blood glucose, insuline and hunger rating.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standard mixed meal (SMM) | Other | Other: vegetable and protein first followed by carbohydrates (VPF) meal sequencestandard mixed meal (SMM) consumed within 15 min to compared to the vegetable protein first followed 10 min later by carbohydrates it with the effect on postprandial glucose ,insulin and hunger rating |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The inclusion criteria were age of 18-59 years
- Emirati, Gulf Cooperation Council (GCC), and Arabs ethnicity
- BMI: 18.5-29.9 kg/m2
- Fasting blood glucose level less than 100 mg/dL
- Non-smoker
Key exclusion criteria (5 listed)
- any participants with pre-existing diabetes
- Pregnant and breastfeeding women
- Participants with behaviors or/and health conditions that are known to affect glucose or -- insulin concentrations, such as smoking, gastrointestinal conditions, bariatric surgery, gastroparesis and reactive hypoglycemia
- Participants who consumed medication that might affect glucose or insulin response
- Participants with reported allergy or intolerance to any of the meal components (White Basmati rice, grilled chicken, cucumber, tomato, and lettuce salad with lemon olive oil dressing).
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 |
|---|---|---|
| vegetable and protein first followed by carbohydrates (VPF) meal sequenceAlso: VPFvegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence | Other | standard mixed meal (SMM) |
Primary outcome
To compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE.
Time frame: 7-10 days
incremental area under the curve
2 secondary outcomes
To compare the effects of the VPF meal sequence vs. SMM sequence on the incremental area under the curve of postprandial insulin response.
Time frame: 2 month
To compare the postprandial hunger response of the VPF meal sequence vs SMM sequence on the area under the curve using a validated visual analog scale for hunger and fullness (VAS)
Time frame: 7-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 28989726Shukla AP, Andono J, Touhamy SH, Casper A, Iliescu RG, Mauer E, Shan Zhu Y, Ludwig DS, Aronne LJ. Carbohydrate-last meal pattern lowers postprandial glucose and insulin excursions in type 2 diabetes. BMJ Open Diabetes Res Care. 2017 Sep 14;5(1):e000440. doi: 10.1136/bmjdrc-2017-000440. eCollection 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vegetable and protein first followed by carbohydrates (VPF) meal sequence in people with Postprandial Hyperglycemia, run by University of Sharjah 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 15 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effects of meal sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose response among healthy adults in the UAE. (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878301, which also lists 1 linked publication.
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 15 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.