Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

• Sponsor: TC Erciyes University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04175496
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Blueberry Cake; Other: Snacks with Cheese; Other: Spicy Crackers; Other: Glucose Solution First Repeat; Other: Glucose Solution Second Repeat	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Criteria

Criteria

• Ages Eligible for Study: 19 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erciyes University Faculty of Health Sciences	Kayseri		Turkey	38100

Sponsors and Collaborators

• TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 13, 2019

More Information

Publications

None provided.

• Responsible Party: Zeynep Caferoglu, PhD, Assistant Professor Doctor, TC Erciyes University
• ClinicalTrials.gov Identifier: NCT04175496
• Other Study ID Numbers: ND
• First Posted: Nov 25, 2019
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zeynep Caferoglu, PhD, Assistant Professor Doctor, TC Erciyes University: Glycemic index; Insulinemic index; Low carbohydrate; Snack; Type 1 diabetes
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

No Results Posted as of Feb 9, 2021