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

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

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:
  • VPF

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.

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

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.

Clinical Trials on Postprandial Hyperglycemia

Subscribe