- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03297931
Comparison of Pulse Chips and Commercial Snacks on Food Intake, Appetite and Blood Glucose in Healthy Young Adults
Comparison of Roasted Pulse Snacks, Pulse Chips and Commercial Snacks on Post-prandial Food Intake, Appetite and Glycemic Response in Healthy Young Adults
Study Overview
Status
Detailed Description
Hypothesis of the study: Inclusion of pulses as part of a snack will lower appetite and post-prandial glycemia (PPG) in comparison to commercial, commonly consumed non-pulse snacks.
Overall Objective of the study: To investigate and compare the effects of pulse and non-pulse snacks served as chips and dip on appetite and PPG in healthy adults.
Specific objectives of the study: To test the acute effects of different pulse snacks on: 1) PPG and appetite for three hours, and 2) food intake 1 hour following consumption of snacks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5S 3E2
- University of Toronto
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: ≥18 and ≤45 years
- BMI: ≥ 18.5 and ≤ 29.9 kg/m2
- Fasting serum glucose: ≤ 5.6 mmol/L
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
- Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the Department of Nutritional Sciences. Failure to comply will result in a rescheduled test visit.
- Willing to abstain from alcohol consumption for 24 h prior to all test visits.
- Willing to avoid vigorous physical activity for 24 h prior to all test visits.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
- Fasting blood glucose > 5.6 mmol/L
- Smoking
- Thyroid problems
- Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
- Presence of gastrointestinal disorder or surgeries within the past year.
- Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement.
- Patients who have undergone bariatric surgery at any point.
- Known to be pregnant or lactating.
- Unwillingness or inability to comply with the experimental procedures
- Known intolerance, sensitivity or allergy to pulses or dairy.
- Extreme dietary habits (ie. Atkins diet, very high protein diets, etc.).
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg) as defined by the average blood pressure measured at screening.
- Weight gain or loss of at least 10 lbs in previous three months.
- Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)
- Restrained Eaters
Study Plan
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: Commercial corn chips + Onion dip
Corn chips + onion dip
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Non-pulse chip + non-pulse dip
|
|
Experimental: Commercial pulse chip + pulse spread
Pinto bean chip + hummus
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Commercial pulse chip + pulse spread
|
|
Experimental: Novel pulse chip + pulse spread
Yellow pea chip + hummus
|
Novel pulse chip + pulse spread
|
|
Experimental: Commercial pulse chip + non-pulse spread
Pinto bean chip + onion dip
|
Commercial pulse chip + non-pulse spread
|
|
Experimental: Novel pulse chip + non-pulse spread
Yellow pea chip + onion dip
|
Novel pulse chip + non-pulse spread
|
|
Experimental: Non-pulse chip + pulse spread
Corn chips + hummus
|
Non-pulse chip + pulse spread
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood glucose levels
Time Frame: Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 190 minutes (time of completion of each session)
|
Each participant will attend 6 sessions in total (randomized 6-arm cross-over design)
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Starting at the beginning of each session (0 minutes, before consumption of treatment) and every 15 - 30 minutes up to 190 minutes (time of completion of each session)
|
|
Subjective appetite
Time Frame: Measured every 15-30 minutes up to 190 minutes
|
Measured using Visual Analog Scales (VAS)
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Measured every 15-30 minutes up to 190 minutes
|
|
Food intake
Time Frame: 65 minutes after completion of treatment, 20 minutes is allocated to allow for pizza consumption
|
Food intake is measured by the amount of pizza (in grams) consumed during the 20 minute period (pizza is served ad libitum)
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65 minutes after completion of treatment, 20 minutes is allocated to allow for pizza consumption
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harvey G Anderson, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPG_Snack Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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