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Completed

NCT Number: NCT05878301

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

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes center ,university of sharjah

Sharjah city, United Arab Emirates

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other

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

Other names: VPF

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.

    Time frame: 7-10 days

    incremental area under the curve

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

University of Sharjah

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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