Clinical trial NCT05878301: Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults
Official title: Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults: A Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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).

Primary outcomes:
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.
timeFrame: 7-10 days
Secondary outcomes:
measure: To compare the effects of the VPF meal sequence vs. SMM sequence on the incremental area under the curve of postprandial insulin response.
timeFrame: 2 month
measure: 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)
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Diabetes center ,university of sharjah
Study officials:
References:
citation: 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.