Effect of Certain Breakfasts on Appetite Control

Not Applicable

Withdrawn

• Conditions: Appetite; Post-prandial Glucose Response
• Interventions: Other: breakfast

• Registration Number: NCT02111486
• Lead Sponsor: St. Boniface Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Study Start: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	breakfast	breakfast food without viscous fibre
breakfast #1	breakfast	breakfast food containing high viscosity fibre
breakfast #2	breakfast	breakfast food containing low viscosity fibre

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

I.H. Asper Clinical Research Institute; 🇨🇦 Winnipeg, Manitoba, Canada

Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada