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
1 other identifier
interventional
14
1 country
1
Brief Summary
This study investigated the effects of thee types of spaghetti No7 on the glycemic response
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedFirst Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedJanuary 19, 2022
January 1, 2022
2 months
January 5, 2022
January 5, 2022
Conditions
Keywords
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
2 hours
Secondary Outcomes (3)
Salivary insulin responses
2 hours
Subjective appetite ratings
2 hours
Blood pressure
2 hours
Study Arms (5)
Glucose as reference food
EXPERIMENTALFourteen 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.
White bread
EXPERIMENTALFourteen 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.
Regular spaghetti No 7
EXPERIMENTALFourteen 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.
Whole wheat spaghetti
EXPERIMENTALFourteen 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.
High fiber - low carbohydrate spaghetti
EXPERIMENTALFourteen 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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
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, 11855, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilia Papakonstantinou
Agricultural University of Athens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- single blind (investigator)
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 19, 2022
Study Start
October 15, 2021
Primary Completion
December 15, 2021
Study Completion
December 30, 2021
Last Updated
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share