Determining the Glycemic Effects of Three Types of Spaghetti

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

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

Study Overview

• Status: Completed
• Conditions: Appetitive Behavior; Potential Abnormality of Glucose Tolerance
• Intervention / Treatment: Other: Glucose as reference food; Other: White bread; Other: Regular spaghetti; Other: Whole wheat spaghetti; Other: High fibre - low carbohydrates spaghetti

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11855
    • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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.; 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.; 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.; 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.
Experimental: 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.	Other: 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.; 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.; 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.; 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.; 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.
Experimental: 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.	Other: 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.; 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.; 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.; 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.; 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.
Experimental: 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.	Other: 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.; 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.; 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.; 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.; 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.
Experimental: 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.	Other: 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.; 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.; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective appetite ratings	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 hours
Salivary insulin responses	Clinically useful change in salivary insulin, defined as the restoration of insulin within normal limits during the 2hr glucose tolerance test	2 hours
Blood pressure	Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the spaghetti products	2 hours

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Investigators: Principal Investigator: Emilia Papakonstantinou, Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: glycemic index; blood glucose; glycemic load; spaghetti
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: HRBD 49 11/10/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No