Acute Glycemic Effects of Crackers Made by Different Flours

Short-term Effects of Crackers on Glycemic Index and Glycemic Responses. A Randomized Trial in Healthy Adults

This study investigated the acute effects of cracker consumption made by different flours on glycemic responses.

Study Overview

• Status: Completed
• Conditions: Appetitive Behavior; Potential Abnormality of Glucose Tolerance
• Intervention / Treatment: Other: Glucose as reference food; Other: Cracker made by wheat flour; Other: Cracker made by rye flour; Other: Cracker made by sunflower flour

Detailed Description

This study aimed to determine the glycemic index and glycemic load of crackers made by different flours (wheat, whole wheat, and 30% sunflower seed flour substitution) and to investigate the effects of these types of crackers on postprandial glycemic responses in healthy humans. Moreover, blood pressure levels and subjective appetite were evaluated.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11855
    • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy
• non-smoking
• non-diabetic men and women
• body mass index between 18 and 25 kg/m2

Exclusion Criteria:

• severe chronic diseases (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
• gastrointestinal disorders
• pregnancy
• lactation
• competitive sports
• alcohol abuse
• drug dependency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucose as reference food; Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.	Other: Glucose as reference food; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Experimental: Cracker made by wheat flour; Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.	Other: Cracker made by wheat flour; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by wheat flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Experimental: Cracker made by rye flour; Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.	Other: Cracker made by rye flour; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from cracker made by rye flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Experimental: Cracker made by sunflower flour; Eleven healthy, normal body weight adults (male: 4, female: 7) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g of available carbohydrates from crackers made by wheat, rye and sunflower flours, tested once, in different visits, along with 300mL water. There was a washout period of at least two days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.	Other: Cracker made by sunflower flour; Eleven healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from sunflower flour, along with 300ml water, tested once, within 10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary blood glucose responses	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test	2 hours
Glycemic index	Glucose solution (50 g) was the reference food (GI = 100%) against which all test foods were compared. Subjects arrived at the laboratory at eight to nine o'clock in the morning after 10-12 h overnight fast. Each subject was fed equivalent 50 g available carbohydrate of test foods or reference food in random order. To minimize day to day variation of glucose tolerance, the reference food was tested in triplicate in each subject. All test and reference foods were served with 250 mL of water. An automatic lancet device and glucometer (calibrated MediSmart Ruby glucose meter with a lancing device, Lilly-PHARMASERV SA, Greece) was used for finger capillary blood samples. Blood samples were taken immediately before the start of the study (0 min) and 15, 30, 45, 60, 90 and 120 min after the start of eating.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite ratings	Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet, one scale per page) at baseline, 15, 30, 45, 60, 90 and 120min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g. hunger, satiety, desire to eat etc	2 hours
Blood pressure	Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the spaghetti productws	2 hours

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Collaborators: Institute of Technology and Agricultural Products
• Investigators: Principal Investigator: Emilia Papakonstantinou, PhD, Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: glycemic index; blood glucose; glycemic load; crackers
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: HRBD 80/12.10.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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