- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878301
Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults
August 14, 2023 updated by: Ayah Shaheen, University of Sharjah
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sharjah, United Arab Emirates
- Diabetes center ,university of sharjah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: standard mixed meal (SMM)
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
|
vegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7-10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
incremental area under the curve
|
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
|
]area under the curve
|
7-10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2023
Primary Completion (Actual)
August 14, 2023
Study Completion (Actual)
August 14, 2023
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
May 17, 2023
First Posted (Actual)
May 26, 2023
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 14, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-22-10-18-S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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