Acute Glycemic Effects of Crackers Made by Different Flours

Appetitive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702372
• Other study ID #: HRBD 80/12.10.2022
• Status: Completed
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: January 19, 2023

Study information

• Verified date: June 2024
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Congenital Abnormalities
• Potential Abnormality of Glucose Tolerance

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Agricultural University of Athens	Institute of Technology and Agricultural Products

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Blood pressure	Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the spaghetti productws	2 hours