Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

NCT04175496 — Not applicable, Completed, 10 participants, TC Erciyes University

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Registry	NCT04175496
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, supportive care
Enrollment	10 (Actual)
Sponsor	TC Erciyes University (Other)
Conditions	Healthy
Interventions	Blueberry Cake, Snacks with Cheese, Spicy Crackers, Glucose Solution First Repeat, Glucose Solution Second Repeat (Other)
Dates	start 2019-12-01, primary completion 2020-03-01, completion 2020-04-01, first posted 2019-11-25, last updated 2021-02-09
Locations	1 site in Turkey (Türkiye)

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Test Foods	Experimental	Other: Blueberry Cake; Other: Snacks with Cheese; Other: Spicy Crackers	Blueberry Cake, Snack with Cheese and spicy Crackers will be used as test foods.
Reference Food	Experimental	Other: Glucose Solution First Repeat; Other: Glucose Solution Second Repeat	Glucose solution will use as reference food.

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.

+Outcome measures

Primary outcomes

Postprandial glucose response [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.
Postprandial insulin response [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.

+Eligibility

Sex: All, ages: 19 Years to 30 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Erciyes University Faculty of Health Sciences	Kayseri	Turkey (Türkiye)

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2019-11-13)