Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia

• Sponsor: University of Manitoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT03223935
• Collaborator: Saskatchewan Pulse Growers (Other), Pulse Canada (Other)
• Enrollment: 32
• Location: 1
• Arms: 6
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.

Condition or Disease	Intervention/Treatment	Phase
Normal Weight; Overweight; Normoglycemic	Other: Corn nuts; Other: Chickpeas; Other: Yellow peas; Other: Pinto beans; Other: Soybeans; Other: Almonds	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized, controlled cross-over acute trialRandomized, controlled cross-over acute trial
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults
• Actual Study Start Date: Aug 11, 2017
• Actual Primary Completion Date: Apr 4, 2018
• Actual Study Completion Date: Apr 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Roasted snacks Corn nuts	Other: Corn nuts; Roasted corn nut snack
Experimental: Roasted chickpeas Chickpeas	Other: Chickpeas; Roasted chickpea snack
Experimental: Roasted yellow peas Yellow peas	Other: Yellow peas; Roasted yellow pea snack
Experimental: Roasted pinto beans Pinto beans	Other: Pinto beans; Roasted pinto bean snack
Experimental: Roasted soybeans Soybeans	Other: Soybeans; Roasted soybean snack
Experimental: Roasted almonds Almonds	Other: Almonds; Roasted almond snack

Outcome Measures

Primary Outcome Measures

1. Food intake [At 60 min]

   Ab libitum meal

Secondary Outcome Measures

1. Subjective appetite [0-200 min]

   Measured by VAS questionnaire at 12 time points used to calculate area under the curve

2. Blood glucose concentrations [0-200 min]

   Measured in blood using a glucometer at 12 time points and used to calculate area under the curve

3. Physical comfort [0-200 min]

   Measured by VAS questionnaire at 12 time points to calculate area under the curve

4. Energy and fatigue [0-200 min]

   Measured by VAS questionnaire at 12 time points to calculate area under the curve

5. Palatability of meal [At 60 min]

   Measured by VAS questionnaire

6. Palatability of treatment [At 5 min]

   Measured by VAS questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba	Canada	R3T 6C5

Sponsors and Collaborators

• University of Manitoba
• Saskatchewan Pulse Growers
• Pulse Canada

Investigators

• Principal Investigator: Peter JH Jones, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT03223935
• Other Study ID Numbers: HS20792 (B2017:059)
• First Posted: Jul 21, 2017
• Last Update Posted: Aug 29, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Aug 29, 2018