NCT05702307

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

January 19, 2023

Last Update Submit

June 9, 2024

Conditions

Potential Abnormality of Glucose ToleranceAppetitive Behavior

Keywords

blood glucosepastaglycemic indexglycemic load

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Subjective appetite ratings

    2 hours

  • Blood pressure

    2 hours

Study Arms (6)

Glucose as reference food

EXPERIMENTAL

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.

Other: Glucose as reference food

Tagliatelle Control

EXPERIMENTAL

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.

Other: Tagliatella control

5% sunflower tagliatelle

EXPERIMENTAL

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.

Other: 5% sunflower tagliatella

16% sunflower tagliatelle

EXPERIMENTAL

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.

Other: 16% sunflower tagliatella

16% sunflower penne

EXPERIMENTAL

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.

Other: 16% sunflower penne

16% sunflower fusilli

EXPERIMENTAL

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.

Other: 16% sunflower fusilli

Interventions

Glucose as reference foodOTHER

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.

Glucose as reference food
Tagliatella controlOTHER

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.

Tagliatelle Control
5% sunflower tagliatellaOTHER

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.

5% sunflower tagliatelle
16% sunflower tagliatellaOTHER

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 tagliatelle
16% sunflower penneOTHER

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 penne
16% sunflower fusilliOTHER

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.

16% sunflower fusilli

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • non-smoking
  • non-diabetic men and women
  • body mass index between 18 and 25 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Emilia Papakonstantinou, PhD

    Agricultural University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind (participant and outcome assessor)
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Crossover assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 27, 2023

Study Start

October 15, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)