Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 3
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Plasma Glucose and Insulin Concentrations
Study Overview
Brief Summary
The objectives are to test the acute effects of different bagels containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.
The investigators hypothesize that bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Normoglycemic (<5.6 mmol/L) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg)
- •BMI of 18.5-29.9 kg/m2
Exclusion Criteria
- •Restrained eaters
- •Regularly skip breakfast
- •Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
- •Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
- •Those unable to walk for an hour continuously
Outcomes
Primary Outcomes
Plasma Glucose and Insulin Concentrations
Time Frame: 0-200
Measured in blood using intravenous catheter at 12 time points used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits
Food Intake
Time Frame: at 120 min
Ad-libitum meal. Food consumed measured by weight
Subjective Appetite
Time Frame: 0-200 min
Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC)
Secondary Outcomes
- Palatability of meal(at 140 mins)
- Physical comfort(0 - 200 min)
- Energy/fatigue measured by VAS questionnaire(0 - 200 mins)
- Palatability of treatments(at 5 mins)
