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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Blueberry Cake; Other: Snacks with Cheese; Other: Spicy Crackers; Other: Glucose Solution First Repeat; Other: Glucose Solution Second Repeat

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38100
    • Erciyes University Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Foods; Blueberry Cake, Snack with Cheese and spicy Crackers will be used as test foods.	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.; Other: 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.; Other: 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.
EXPERIMENTAL: Reference Food; Glucose solution will use as reference food.	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Glycemic index; Snack; Low carbohydrate; Insulinemic index
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: ND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No