Acute Glycemic Effects of Crackers Made by Different Flours

NCT05702372 | Completed DMC

• 1 other identifier: HRBD 80/12.10.2022
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Potential Abnormality of Glucose Tolerance; Appetitive Behavior

Keywords

blood glucose; crackers; glycemic index; glycemic load

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Subjective appetite ratings

  2 hours

• Blood pressure

  2 hours

Study Arms (4)

Glucose as reference food

EXPERIMENTAL

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

Cracker made by wheat flour

EXPERIMENTAL

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

Cracker made by rye flour

EXPERIMENTAL

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

Cracker made by sunflower flour

EXPERIMENTAL

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

Interventions

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.

Glucose as reference food

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 wheat flour

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 rye flour

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.

Cracker made by sunflower flour

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead
• Institute of Technology and Agricultural Products: collaborator

Study Sites (1)

Agricultural University of Athens

Athens, 11855, Greece

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Emilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind (investigator and outcomes assessor)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Crossover assignment

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 27, 2023
• Study Start: September 19, 2022
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)