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Completed

NCT Number: NCT04175496

Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

The aim of this study is develop recipes containing CHO less than ICR, prepare new snacks alternatives that could be consumed without need for additional insulin doses, and evaluate the glycemic and insulinemic responses of these recipes. A randomized crossover trial will include 15 healthy adults aged 19-30 years. All participants will consume 3 test foods and reference food (glucose solution, 2 times) in a random order. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min. Glucose and insulin analyzes will be performed from blood samples. The results of these time points will be marked on the chart and the incremental area under the curve (iAUC) will be calculated for both glucose and insulin.

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Key information

Conditions

Healthy Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Health Sciences

Kayseri, 38100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteer
  • Normal body weight (18.5-25 kg / m2 BMI)
  • 19-30 years old

Exclusion criteria

  • use of tobacco,
  • weight change of >5 kg in the last 3 months
  • the presence of any chronic disease or lactose intolerance,
  • regular medicine use,
  • pregnancy or lactation,
  • performing competitive sports or endurance sports,
  • fasting plasma glucose concentration >100 mg / dL,
  • the presence of eating disorder,
  • sensitivity or allergies to any food that used in the study

Treatment and study plan

Blueberry Cake

Other

Blueberry cake containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.

Snacks with Cheese

Other

Snacks with cheese containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.

Spicy Crackers

Other

Spicy crackers containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.

Glucose Solution First Repeat

Other

The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.

Glucose Solution Second Repeat

Other

The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.

Primary outcomes

  1. Postprandial glucose response

    Time frame: two hours postprandial period

    Postprandial glucose response will be quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which is calculated according to the trapezoidal rule by using blood glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes.

  2. Postprandial insulin response

    Time frame: two hours postprandial period

    Postprandial insulin response will be quantified as incremental area under the curve (iAUC) (mg/dL x minutes), which is calculated according to the trapezoidal rule by using blood glucose values at time points 0, 15, 30, 45, 60, 90, and 120 minutes.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Feb 9, 2021

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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