Effect of Certain Breakfasts on Appetite Control

A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.

This clinical trial is being conducted to study whether eating certain meals will reduce your desire to eat and for a longer period of time compared to others and to determine the post-meal glucose response associated with each of these breakfast foods.

Study Overview

• Status: Withdrawn
• Conditions: Appetite; Post-prandial Glucose Response
• Intervention / Treatment: Other: breakfast

Detailed Description

The study is divided into 3 phases. Each phase involves eating one of 3 different breakfasts every day for 1 month. The order of the breakfast products is random. During each phase participants will come to the research clinic for 4 visits (1 per week) for assessment of appetite-related sensations. Gastric emptying will be assessed at 1 visit per phase and post prandial glucose response will be measured at 1 visit per phase (Asper site only).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • I.H. Asper Clinical Research Institute
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Centre for Functional Foods and Nutraceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy Males and females (not pregnant or lactating) aged 19 to 60 years.
2. Body mass index: 18.5-30 kg/m2.

Exclusion Criteria:

1. A change in medication (dose or type) or medical event requiring hospitalization within the past month.
2. Daily tobacco use.
3. Physical Activity Level >1.8.
4. Eat meals at irregular or unusual times.
5. Food allergy, aversion or unwillingness to eat study foods.
6. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect appetite or blood sugar.
7. Presence of a gastrointestinal disorder.
8. Taking drugs that affect gastric emptying.
9. Score >65% on any 1 of the 3 categories of the Three Factor Eating Questionnaire-R18.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: breakfast #1; breakfast food containing high viscosity fibre	Other: breakfast
EXPERIMENTAL: breakfast #2; breakfast food containing low viscosity fibre	Other: breakfast
PLACEBO_COMPARATOR: Control; breakfast food without viscous fibre	Other: breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	Total area under the curve (AUC) for hunger, fullness, desire to eat, and prospective consumption scales	before the breakfast and every 30 minutes after breakfast for 4 hours
Gastric emptying rate	13C-Octanoic Acid will be incorporated into the breakfast food. Rate of gastric emptying will be determined by measuring 13C in breath samples.	before the breakfast and every 15 minutes after breakfast for 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose and Insulin	Total area under the curve (iAUC, mmol*min/L) for both glucose and insulin	before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.
Kilocalories	Measure the amount of kilocalories consumed throughout each test day.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal side effects	Incidence and duration of gastrointestinal side effects.	4 weeks

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: Agriculture and Agri-Food Canada
• Investigators: Principal Investigator: Heather Blewett, Ph.D, I.H. Asper Clinical Research Institute/Agriculture and Agri-Food Canada; Principal Investigator: Nancy Ames, PhD, Richardson Centre for Functional Foods and Nutraceuticals/Agriculture and Agri-Food Canada

Publications and helpful links

General Publications

• Beck EJ, Tosh SM, Batterham MJ, Tapsell LC, Huang XF. Oat beta-glucan increases postprandial cholecystokinin levels, decreases insulin response and extends subjective satiety in overweight subjects. Mol Nutr Food Res. 2009 Oct;53(10):1343-51. doi: 10.1002/mnfr.200800343.
• Blundell J, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. Appetite control: methodological aspects of the evaluation of foods. Obes Rev. 2010 Mar;11(3):251-70. doi: 10.1111/j.1467-789X.2010.00714.x. Epub 2010 Jan 29.
• Pentikainen S, Karhunen L, Flander L, Katina K, Meynier A, Aymard P, Vinoy S, Poutanen K. Enrichment of biscuits and juice with oat beta-glucan enhances postprandial satiety. Appetite. 2014 Apr;75:150-6. doi: 10.1016/j.appet.2014.01.002. Epub 2014 Jan 14.
• Thondre PS, Henry CJ. High-molecular-weight barley beta-glucan in chapatis (unleavened Indian flatbread) lowers glycemic index. Nutr Res. 2009 Jul;29(7):480-6. doi: 10.1016/j.nutres.2009.07.003.
• de Graaf C, Blom WA, Smeets PA, Stafleu A, Hendriks HF. Biomarkers of satiation and satiety. Am J Clin Nutr. 2004 Jun;79(6):946-61. doi: 10.1093/ajcn/79.6.946.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (ESTIMATE): April 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Satiety; Gastric emptying; Glucose; Fibre; Breakfast
• Other Study ID Numbers: B2014:027