- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02015429
Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake
December 12, 2013 updated by: G. Harvey Anderson, University of Toronto
The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 3E2
- University of Toronto
-
Toronto, Ontario, Canada, M5S 3E2
- University of Toronto - Department of Nutritional Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Non-smoking
- No metabolic disease
- BMI 20 - 25 kg/m^2
- male
- age 20-30
Exclusion Criteria:
- Intolerance to treatments
- on appetite-modifying medications
- restrictive eating
- smoking
- over or underweight
- breakfast-skipping
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Pasta meal with added fractions or control with no fractions Pasta meal with no pea fractions
|
|
Experimental: 10 g protein
Pasta meal with added fractions or control with no fractions 10 g net yellow pea protein added to pasta meal
|
|
Experimental: 7 g yellow pea fibre
Pasta meal with added fractions or control with no fractions 7 g net yellow pea fibre added to pasta meal
|
|
Experimental: Yellow pea fibre & protein
Pasta meal with added fractions or control with no fractions 10 g net yellow pea protein plus 7 g net yellow pea fibre added to pasta meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ad libitum food intake at second pizza meal
Time Frame: 135 mins after completion of treatment, 20 mins to eat pizza meal.
|
Food intake measured via electronic scale in g, then converted to kcal using the caloric density.
|
135 mins after completion of treatment, 20 mins to eat pizza meal.
|
Blood glucose
Time Frame: between 0 and 215 mins, every 15-30 mins
|
Blood glucose measured via hand-held glucometer and finger prick.
|
between 0 and 215 mins, every 15-30 mins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective appetite
Time Frame: 0 to 215 minutes
|
Measured via Visual Analog Scales (VAS)
|
0 to 215 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Palatability of treatments
Time Frame: following treatment consumption at 15 mins
|
Measured by VAS to ensure palatability is not confounding other outcomes.
|
following treatment consumption at 15 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 12, 2013
First Posted (Estimate)
December 19, 2013
Study Record Updates
Last Update Posted (Estimate)
December 19, 2013
Last Update Submitted That Met QC Criteria
December 12, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Pea_Fractionation_mixed_meal
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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