Back to resultsRoasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
Primary Purpose
Normal Weight, Overweight, Normoglycemic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Corn nuts
Chickpeas
Yellow peas
Pinto beans
Soybeans
Almonds
Sponsored by
About this trial
This is an interventional other trial for Normal Weight
Eligibility Criteria
Inclusion Criteria:
- BMI: ≥18.5 and ≤29.9 kg/m2
- Fasting serum glucose: ≤5.5 mmol/L
Exclusion Criteria:
- Fasting serum glucose > 5.5 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 a 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 judgment
- Known to be pregnant or lactating
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
- Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
- Weight gain or loss of at least 10lbs in previous three months
- Excessive alcohol intake
- Restrained Eaters (identified by Eating Habits Questionnaire)
Sites / Locations
- Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Roasted snacks
Roasted chickpeas
Roasted yellow peas
Roasted pinto beans
Roasted soybeans
Roasted almonds
Arm Description
Corn nuts
Chickpeas
Yellow peas
Pinto beans
Soybeans
Almonds
Outcomes
Primary Outcome Measures
Food intake
Ab libitum meal
Secondary Outcome Measures
Subjective appetite
Measured by VAS questionnaire at 12 time points used to calculate area under the curve
Blood glucose concentrations
Measured in blood using a glucometer at 12 time points and used to calculate area under the curve
Physical comfort
Measured by VAS questionnaire at 12 time points to calculate area under the curve
Energy and fatigue
Measured by VAS questionnaire at 12 time points to calculate area under the curve
Palatability of meal
Measured by VAS questionnaire
Palatability of treatment
Measured by VAS questionnaire
Full Information
NCT ID
NCT03223935
First Posted
July 6, 2017
Last Updated
January 19, 2023
Sponsor
University of Manitoba
Collaborators
Saskatchewan Pulse Growers, Pulse Canada
1. Study Identification
Unique Protocol Identification Number
NCT03223935
Brief Title
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
Official Title
A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Saskatchewan Pulse Growers, Pulse Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.
Detailed Description
An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in 200 kcal servings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Weight, Overweight, Normoglycemic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, controlled cross-over acute trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roasted snacks
Arm Type
Active Comparator
Arm Description
Corn nuts
Arm Title
Roasted chickpeas
Arm Type
Experimental
Arm Description
Chickpeas
Arm Title
Roasted yellow peas
Arm Type
Experimental
Arm Description
Yellow peas
Arm Title
Roasted pinto beans
Arm Type
Experimental
Arm Description
Pinto beans
Arm Title
Roasted soybeans
Arm Type
Experimental
Arm Description
Soybeans
Arm Title
Roasted almonds
Arm Type
Experimental
Arm Description
Almonds
Intervention Type
Other
Intervention Name(s)
Corn nuts
Intervention Description
Roasted corn nut snack
Intervention Type
Other
Intervention Name(s)
Chickpeas
Intervention Description
Roasted chickpea snack
Intervention Type
Other
Intervention Name(s)
Yellow peas
Intervention Description
Roasted yellow pea snack
Intervention Type
Other
Intervention Name(s)
Pinto beans
Intervention Description
Roasted pinto bean snack
Intervention Type
Other
Intervention Name(s)
Soybeans
Intervention Description
Roasted soybean snack
Intervention Type
Other
Intervention Name(s)
Almonds
Intervention Description
Roasted almond snack
Primary Outcome Measure Information:
Title
Food intake
Description
Ab libitum meal
Time Frame
At 60 min
Secondary Outcome Measure Information:
Title
Subjective appetite
Description
Measured by VAS questionnaire at 12 time points used to calculate area under the curve
Time Frame
0-200 min
Title
Blood glucose concentrations
Description
Measured in blood using a glucometer at 12 time points and used to calculate area under the curve
Time Frame
0-200 min
Title
Physical comfort
Description
Measured by VAS questionnaire at 12 time points to calculate area under the curve
Time Frame
0-200 min
Title
Energy and fatigue
Description
Measured by VAS questionnaire at 12 time points to calculate area under the curve
Time Frame
0-200 min
Title
Palatability of meal
Description
Measured by VAS questionnaire
Time Frame
At 60 min
Title
Palatability of treatment
Description
Measured by VAS questionnaire
Time Frame
At 5 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI: ≥18.5 and ≤29.9 kg/m2
Fasting serum glucose: ≤5.5 mmol/L
Exclusion Criteria:
Fasting serum glucose > 5.5 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 a 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 judgment
Known to be pregnant or lactating
Known intolerance, sensitivity or allergy to any ingredients in the study products.
Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
Weight gain or loss of at least 10lbs in previous three months
Excessive alcohol intake
Restrained Eaters (identified by Eating Habits Questionnaire)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter JH Jones, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 6C5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data requests should be submitted to the PI.
Learn more about this trial
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
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