Determining the Glycemic Effects of Sunflower Pasta

Appetitive Behavior Clinical Trial

Official title:

Determining the Effects of Sunflower Pasta on Glycemic Responses in Healthy Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702307
• Other study ID #: HRBD 60 23/06/2022
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: January 15, 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 effects of five types of pasta on the glycemic responses

Description:

This study aimed to 1.determine the glycemic index and glycemic load of five types of pasta (tagliatella control, 5% sunflower tagliatella, 16% sunflower tagliatella, 16% sunflower penne and 16% sunflower fusilli) and 2. investigate the effects of these pasta types on postprandial glycemic responses in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 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 disease (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
Fifteen 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 and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
• Tagliatella control
Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from tagliatella control, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
• 5% sunflower tagliatella
Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 5% sunflower tagliatella, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
• 16% sunflower tagliatella
Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 16% sunflower tagliatella, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
• 16% sunflower penne
Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 16% sunflower penne, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and samples from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
• 16% sunflower fusilli
Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 16% sunflower fusilli, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica

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	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	2hr
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 pasta products	2 hours