Determining the Glycemic Effects of Three Types of Spaghetti

NCT ID: NCT05197283

Last Updated: 2022-01-19

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2021-12-30

Brief Summary

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

Detailed Description

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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

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

SINGLE

Investigators
single blind (investigator)

Study Groups

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Glucose as reference food

Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

White bread

Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Regular spaghetti No 7

Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Whole wheat spaghetti

Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

High fiber - low carbohydrate spaghetti

Fourteen healthy, normal body weight adults (male: 6, female: 10) after 12hr fast, consumed 50g available carbohydrates from D-glucose, tested two times, in different visits as reference food; and 50g available carbohydrates from white bread, tested two times; and 50 gr available carbohydrates from spaghetti No7 types, regular, whole wheat and low carbohydrates - high fibre, 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 and salivary insulin samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose and salivary insulin sample was taken exactly 15min after the first bite of food or drink.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Glucose as reference food

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.

Intervention Type OTHER

White bread

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.

Intervention Type OTHER

Regular spaghetti

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.

Intervention Type OTHER

Whole wheat spaghetti

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.

Intervention Type OTHER

High fibre - low carbohydrates spaghetti

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.

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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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

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

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Agricultural University of Athens

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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HRBD 49 11/10/2021

Identifier Type: -

Identifier Source: org_study_id

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