Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

Healthy Clinical Trial

Official title:

Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175496
• Other study ID #: ND
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Blueberry Cake
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
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
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
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
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.

Locations

Country	Name	City	State
Turkey	Erciyes University Faculty of Health Sciences	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose response	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.	two hours postprandial period
Primary	Postprandial insulin response	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.	two hours postprandial period