search
Back to results

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

Primary Purpose

Postprandial Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
vegetable and protein first followed by carbohydrates (VPF) meal sequence
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postprandial Hyperglycemia

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Diabetes center ,university of sharjah

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

standard mixed meal (SMM)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
May 17, 2023
Last Updated
August 14, 2023
Sponsor
University of Sharjah
search

1. Study Identification

Unique Protocol Identification Number
NCT05878301
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
August 14, 2023 (Actual)
Study Completion Date
August 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard mixed meal (SMM)
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
vegetable and protein first followed by carbohydrates (VPF) meal sequence
Other Intervention Name(s)
VPF
Intervention Description
vegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence
Primary Outcome Measure Information:
Title
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.
Description
incremental area under the curve
Time Frame
7-10 days
Secondary Outcome Measure Information:
Title
To compare the effects of the VPF meal sequence vs. SMM sequence on the incremental area under the curve of postprandial insulin response.
Description
incremental area under the curve
Time Frame
2 month
Title
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)
Description
]area under the curve
Time Frame
7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
Diabetes center ,university of sharjah
City
Sharjah
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28989726
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs