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Clinical Trials/NCT02402504
NCT02402504CompletedNot Applicable

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 1

University of Manitoba1 site in 1 country30 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Food Intake

Study Overview

Brief Summary

The objectives are to test the acute effects of different extruded pulse snacks 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 snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.

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 on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
  • Competitive sports or athletic training at a high intensity
  • Those unable to walk for an hour continuously

Arms & Interventions

Extruded snack with pinto bean flour

Experimental

60% corn flour and 40% pinto bean flour

Intervention: Pinto bean flour (Other)

Extruded snack control

Placebo Comparator

100% corn flour

Intervention: Control (Other)

Extruded snack with small particle size pea flour

Experimental

60% corn flour and 40% small particle size pea flour

Intervention: Small particle size pea flour (Other)

Extruded snack with large particle size pea flour

Experimental

60% corn flour and 40% large particle size pea flour

Intervention: Large particle size pea flour (Other)

Extruded snack with lentil flour

Experimental

60% corn flour and 40% lentil flour

Intervention: Lentil flour (Other)

Extruded snack navy bean flour

Experimental

60% corn flour and 40% navy bean flour

Intervention: Navy bean flour (Other)

Outcomes

Primary Outcomes

Food Intake

Time Frame: at 120 min

Ad-libitum meal

Subjective Appetite

Time Frame: 0-200 min

Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)

Plasma Glucose and Insulin Concentrations

Time Frame: 0 - 200 min

Measured in blood using intravenous catheter at 12 time points and 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 (Composite measure)

Secondary Outcomes

  • Physical Comfort(0-200 min)
  • Palatability of meal(at 140 minutes)
  • Palatability of treatments(at 5 minutes)
  • Energy and Fatigue(0-200 min)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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