Determining the Glycemic Effects of Three Types of Spaghetti

Appetitive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197283
• Other study ID #: HRBD 49 11/10/2021
• Status: Completed
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2022
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 30, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Congenital Abnormalities
• Potential Abnormality of Glucose Tolerance

Intervention

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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood pressure	Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the spaghetti products	2 hours