PERFECT Project – Part 1 – Study 2

Overview

The objectives are to test the acute effects of different cereals 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. We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.

Full Title of Study: “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 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: March 2017

Interventions

  • Other: Control
    • Non pulse extruded cereal
  • Other: Pea protein
    • Pulse extruded cereal
  • Other: Pea starch
    • Pulse extruded cereal
  • Other: Pea fibre + pea starch
    • Pulse extruded cereal
  • Other: Pea protein + pea starch
    • Pulse extruded cereal
  • Other: Pea fibre + pea starch + pea protein
    • Pulse extruded cereal

Arms, Groups and Cohorts

  • Placebo Comparator: Cereal control
    • 100% Wheat Flour
  • Experimental: Cereal with pea protein
    • Pea protein
  • Experimental: Cereal with pea starch
    • Pea starch
  • Experimental: Cereal w/ pea starch + pea fibre: 5g
    • Pea starch + pea fibre: 5g
  • Experimental: Cereal w/ pea protein + pea starch: 10g
    • Pea protein + pea starch: 10g
  • Experimental: Cereal w/ pea protein + pea fibre + pea starch: 20g
    • Pea protein + pea fibre + pea starch: 20g

Clinical Trial Outcome Measures

Primary Measures

  • Plasma Glucose and Insulin Concentrations
    • Time Frame: 0 – 200 min
    • 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
    • Measured by VAS questionnaire
  • Subjective Appetite
    • Time Frame: 0-200 min
    • Motivation-to-eat VAS questionnaire

Secondary Measures

  • Palatability of treaments and meal
    • Time Frame: 5 and 140 minutes
    • Measured by VAS questionnaire
  • Physical comfort
    • Time Frame: 0 – 200 min
    • Measured by VAS questionnaire
  • Energy/fatigue
    • Time Frame: 0-200 min
    • Measured by VAS questionnaire

Participating in This Clinical Trial

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 – Smokers – Competitive sports or athletic training at a high intensity – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Manitoba
  • Collaborator
    • Saskatchewan Pulse Growers
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter JH Jones, PhD, Principal Investigator, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals

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