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Clinical Trials/NCT05702372
NCT05702372
Completed
Not Applicable

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

Agricultural University of Athens1 site in 1 country11 target enrollmentStarted: September 19, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Glycemic index

Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

double-blind (investigator and outcomes assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Glycemic index

Time Frame: 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

Time Frame: 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

  • Blood pressure(2 hours)
  • Subjective appetite ratings(2 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aimilia Papakonstantinou

Assistant Professor

Agricultural University of Athens

Study Sites (1)

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