Acute Glycemic Effects of Crackers Made by Different Flours

NCT05702372 — Not applicable, Completed, 11 participants, Agricultural University of Athens

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

Registry	NCT05702372
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, other
Enrollment	11 (Actual)
Sponsor	Agricultural University of Athens (Other); collaborators: Institute of Technology and Agricultural Products
Conditions	Potential Abnormality of Glucose Tolerance, Appetitive Behavior
Interventions	Glucose as reference food, Cracker made by wheat flour, Cracker made by rye flour, Cracker made by sunflower flour (Other)
Dates	start 2022-09-19, primary completion 2023-01-19, completion 2023-01-19, first posted 2023-01-27, last updated 2024-06-14
Locations	1 site in Greece

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Glucose as reference food	Experimental	Other: 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.
Cracker made by wheat flour	Experimental	Other: 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.
Cracker made by rye flour	Experimental	Other: 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.
Cracker made by sunflower flour	Experimental	Other: 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.

Glucose as reference food (Other): 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 (Other): 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 (Other): 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 (Other): 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.

+Outcome measures

Primary outcomes

Glycemic index [2 hours]: 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.
Capillary blood glucose responses [2 hours]: Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test

Secondary outcomes

Subjective appetite ratings [2 hours]: 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
Blood pressure [2 hours]: Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the spaghetti productws

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Agricultural University of Athens	Athens	Greece

+Publications

Results publication: Papakonstantinou E, Alsab V, Lympaki F, Chanioti S, Giannoglou M, Katsaros G. The acute effects of variations in the flour composition of crackers on the glycemic index and glycemic responses in healthy adults. Eur J Clin Nutr. 2024 Dec;78(12):1051-1057. doi: 10.1038/s41430-024-01482-0. Epub 2024 Aug 5. PMID 39103546

+Investigators

Emilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens