Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults

Postprandial Hyperglycemia Clinical Trial

Official title:

Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults: A Randomized Controlled Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05878301
• Other study ID #: REC-22-10-18-S
• Status: Completed
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: August 14, 2023

Study information

• Verified date: August 2023
• Source: University of Sharjah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

Other:
• vegetable and protein first followed by carbohydrates (VPF) meal sequence
vegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence

Locations

Country	Name	City	State
United Arab Emirates	Diabetes center ,university of sharjah	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7-10 days
Secondary	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	2 month
Secondary	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	7-10 days