Determining the Glycemic Effects of Sunflower Pasta

NCT ID: NCT05702307

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2023-01-15

Brief Summary

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

Detailed Description

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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

Conditions

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Potential Abnormality of Glucose Tolerance Appetitive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover assignment
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
double blind (participant and outcome assessor)

Study Groups

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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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type 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.

Tagliatelle 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.

Group Type EXPERIMENTAL

Tagliatella control

Intervention Type 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 tagliatelle

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.

Group Type EXPERIMENTAL

5% sunflower tagliatella

Intervention Type 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 tagliatelle

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.

Group Type EXPERIMENTAL

16% sunflower tagliatella

Intervention Type 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

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.

Group Type EXPERIMENTAL

16% sunflower penne

Intervention Type 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

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.

Group Type EXPERIMENTAL

16% sunflower fusilli

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Technology and Agricultural Products

UNKNOWN

Sponsor Role collaborator

Agricultural University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Aimilia Papakonstantinou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emilia Papakonstantinou, PhD

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

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Agricultural University of Athens

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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HRBD 60 23/06/2022

Identifier Type: -

Identifier Source: org_study_id

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