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Completed

NCT Number: NCT05702307

Determining the Glycemic Effects of Sunflower Pasta

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agricultural University of Athens

Athens, Attica, 11855, Greece

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose as reference food

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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.

Primary outcomes

  1. Capillary blood glucose responses

    Time frame: 2hr

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

Secondary outcomes

  1. Subjective appetite ratings

    Time frame: 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

  2. Blood pressure

    Time frame: 2 hours

    Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the pasta products

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Collaborators

  • Institute of Technology and Agricultural Products

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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