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Completed

NCT Number: NCT05197283

Determining the Glycemic Effects of Three Types of Spaghetti

This study investigated the effects of thee types of spaghetti No7 on the glycemic response

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Key information

Conditions

Potential Abnormality of Glucose Tolerance Appetitive Behavior Behavior Behavior, Animal

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Agricultural University of Athens

Athens, 11855, Greece

About this study

This study aimed to 1. determine the glycemic index and glycemic load of thee spaghetti No7 types (regular, whole wheat and high fiber-low carbohydrates) and 2. investigate the effects of these spaghetti types on postprandial glycemic response 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

Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested two times, in different visits, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

White Bread

Other

Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from white bread, along with 300ml water, tested two times, in different visits, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Regular spaghetti

Other

Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from regular spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Whole wheat spaghetti

Other

Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from whole wheat spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

High fibre - low carbohydrates spaghetti

Other

Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from high fibre - low carbohydrate spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Primary outcomes

  1. 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

  1. Salivary insulin responses

    Time frame: 2 hours

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

  2. 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

  3. Blood pressure

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

Agricultural University of Athens

Other

Registry information

Official study title

Determining the Effect of Three Types of Spaghetti (Regular, Whole Wheat and High Fiber-low Carbohydrates) on Glycemic Responses in Healthy Humans

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

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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