Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods

NCT ID: NCT04175496

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-04-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Test Foods

Blueberry Cake, Snack with Cheese and spicy Crackers will be used as test foods.

Group Type: EXPERIMENTAL

Blueberry Cake

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Reference Food

Glucose solution will use as reference food.

Group Type: EXPERIMENTAL

Glucose Solution First Repeat

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Zeynep Caferoglu, PhD

Assistant Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes University Faculty of Health Sciences

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ND

Identifier Type: -

Identifier Source: org_study_id