NCT05878301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

May 17, 2023

Last Update Submit

August 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • To compare the effects of the VPF meal sequence vs. SMM sequence on the incremental area under the curve of postprandial insulin response.

    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)

    7-10 days

Study Arms (1)

standard mixed meal (SMM)

OTHER

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

Other: vegetable and protein first followed by carbohydrates (VPF) meal sequence

Interventions

vegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence

Also known as: VPF
standard mixed meal (SMM)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes center ,university of sharjah

Sharjah city, United Arab Emirates

Location

Related 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.

    PMID: 28989726BACKGROUND

MeSH Terms

Conditions

Hyperglycemia

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical dietitian

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 26, 2023

Study Start

June 9, 2023

Primary Completion

August 14, 2023

Study Completion

August 14, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations