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

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 Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Other: Dietary intervention

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S3E2
      • Department of Nutritional Sciences, University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Snack bar 1; Dietary intervention: 190 Kcal, 12g fat, 14g carbohydrate, 5g fibre, 6g sugar, 10g protein	Other: Dietary intervention; All arms are given to all participants, in a randomized order
Experimental: Snack bar 2; Dietary intervention: 200 Kcal, 15g fat, 12g carbohydrate, 5g fibre, 4g sugar, 8g protein	Other: Dietary intervention; All arms are given to all participants, in a randomized order
Experimental: Snack bar 3; Dietary intervention: 210 Kcal, 16g fat, 12g carbohydrate, 2g fibre, 6g sugar, 6g protein	Other: Dietary intervention; All arms are given to all participants, in a randomized order
Experimental: Control 1; Dietary intervention: Water (500 g)	Other: Dietary intervention; All arms are given to all participants, in a randomized order
Experimental: Control 2; Dietary intervention: White bread (190 Kcal, 2g fat, 37g carbohydrate, 2g fibre, 3g sugar, 6g protein)	Other: Dietary intervention; All arms are given to all participants, in a randomized order
Experimental: Control 3; Dietary intervention: Soft baked pretzel (190 Kcal, 2g fat, 38g carbohydrate, 2g fibre, 6g sugar, 4g protein)	Other: Dietary intervention; All arms are given to all participants, in a randomized order

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	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	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived satiety	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	120 minutes
Blood glucose	Blood glucose (mmol/L) is measured using finger prick capillary blood samples	0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments
Blood insulin	Blood insulin (μU/mL) is measured using finger prick capillary blood samples	0 to 120 min (pre-ad libitum lunch) and 140 to 260 min (post-ad libitum lunch) after consumption of treatments

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Recall	Participants are asked to complete a 24-hour Food Recall starting at dinner the night before each study session and ending at dinner the day of that session.	24 hours

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: General Mills

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Satiety; Postprandial glycemia; Food intake; Breakfast cereals/snacks
• Other Study ID Numbers: 30422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO