Determining the Glycemic Effects of Sunflower Pasta

Not Applicable

Completed

• Conditions: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
• Interventions: Other: Glucose as reference food; Other: 5% sunflower tagliatella; Other: 16% sunflower tagliatella; Other: Tagliatella control; Other: 16% sunflower fusilli; Other: 16% sunflower penne

• Registration Number: NCT05702307
• Lead Sponsor: Agricultural University of Athens

Brief Summary

This study investigated the effects of five types of pasta on the glycemic responses

Detailed 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

Study Timeline

• Study Start: 2022-10-15
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-09
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose as reference food	Glucose as reference food	Sixteen healthy, normal body weight adults after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from tagliatelle control, 5% sunflower tagliatelle, 16% sunflower tagliatelle, 16% sunflower penne, and 16% sunflower fusilli, 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 and measurements from continuous glucose monitoring system 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.
5% sunflower tagliatelle	5% sunflower tagliatella	Sixteen healthy, normal body weight adults after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from tagliatelle control, 5% sunflower tagliatelle, 16% sunflower tagliatelle, 16% sunflower penne, and 16% sunflower fusilli, 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 and measurements from continuous glucose monitoring system 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.
16% sunflower tagliatelle	16% sunflower tagliatella	Sixteen healthy, normal body weight adults after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from tagliatelle control, 5% sunflower tagliatelle, 16% sunflower tagliatelle, 16% sunflower penne, and 16% sunflower fusilli, 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 and measurements from continuous glucose monitoring system 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.
Tagliatelle Control	Tagliatella control	Sixteen healthy, normal body weight adults after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from tagliatelle control, 5% sunflower tagliatelle, 16% sunflower tagliatelle, 16% sunflower penne, and 16% sunflower fusilli, 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 and measurements from continuous glucose monitoring system 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.
16% sunflower fusilli	16% sunflower fusilli	Sixteen healthy, normal body weight adults after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from tagliatelle control, 5% sunflower tagliatelle, 16% sunflower tagliatelle, 16% sunflower penne, and 16% sunflower fusilli, 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 and measurements from continuous glucose monitoring system 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.
16% sunflower penne	16% sunflower penne	Sixteen healthy, normal body weight adults after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from tagliatelle control, 5% sunflower tagliatelle, 16% sunflower tagliatelle, 16% sunflower penne, and 16% sunflower fusilli, 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 and measurements from continuous glucose monitoring system 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.

Primary Outcome Measures

Name	Time	Method
Capillary blood glucose responses	2hr	Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
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 pasta products

Trial Locations

Locations (1)

Agricultural University of Athens; 🇬🇷 Athens, Attica, Greece