Innovation of Breakfast Cereals and Snacks for Control of Appetite and Post-Prandial Glycemia

Overview

The goal of the proposed research is to investigate the effects of novel snack products differing in macronutrient composition, fibre and sugar content on post-prandial glycemia and short-term appetite control in healthy adults.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

Interventions

  • Other: Dietary intervention
    • All arms are given to all participants, in a randomized order

Arms, Groups and Cohorts

  • Experimental: Snack bar 1
    • Dietary intervention: 190 Kcal, 12g fat, 14g carbohydrate, 5g fibre, 6g sugar, 10g protein
  • Experimental: Snack bar 2
    • Dietary intervention: 200 Kcal, 15g fat, 12g carbohydrate, 5g fibre, 4g sugar, 8g protein
  • Experimental: Snack bar 3
    • Dietary intervention: 210 Kcal, 16g fat, 12g carbohydrate, 2g fibre, 6g sugar, 6g protein
  • Experimental: Control 1
    • Dietary intervention: Water (500 g)
  • Experimental: Control 2
    • Dietary intervention: White bread (190 Kcal, 2g fat, 37g carbohydrate, 2g fibre, 3g sugar, 6g protein)
  • Experimental: Control 3
    • Dietary intervention: Soft baked pretzel (190 Kcal, 2g fat, 38g carbohydrate, 2g fibre, 6g sugar, 4g protein)

Clinical Trial Outcome Measures

Primary Measures

  • Food intake
    • Time Frame: 120 minutes
    • Food intake (kCal) is assessed 120 min after consumption of the treatments, using an ad libitum pizza lunch design. Participants are asked to eat, during a 20-min period, until feeling comfortably full

Secondary Measures

  • Perceived satiety
    • Time Frame: 120 minutes
    • Satiety scores (mm) are assessed using 100-mm “Motivation to Eat” visual analog scale questionnaires. A composite score of the four appetite questions, including Desire to Eat, Hunger, Fullness and Prospective Food Consumption, in the “Motivation to Eat” visual analog scale is calculated to obtain the average appetite score for statistical analysis
  • Blood glucose
    • Time Frame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
    • Blood glucose (mmol/L) is measured using finger prick capillary blood samples
  • Blood insulin
    • Time Frame: 0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
    • Blood insulin (μU/mL) is measured using finger prick capillary blood samples

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy, non-smoking individuals aged 18-55 years with a body mass index of 20.0-29.9 kg/m2

Exclusion Criteria

  • Smokers, individuals with diabetes or other cardiometabolic diseases, persons who suffer from gastrointestinal disorders or have had gastric surgery, or people who regularly use bulk laxatives
  • Women with irregular menstruation or who use hormonal contraceptives or hormone replacement therapy
  • Individuals who regularly skip breakfast, have allergies to any of the test food ingredients, or who follow a restrictive diet

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Toronto
  • Collaborator
    • General Mills Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: G. Harvey Anderson, Professor – University of Toronto
  • Overall Official(s)
    • G. Harvey Anderson, PhD, Principal Investigator, University of Toronto

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