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Clinical Trials/NCT02111486
NCT02111486
Withdrawn
Not Applicable

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

St. Boniface Hospital2 sites in 1 countryOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Appetite
Sponsor
St. Boniface Hospital
Locations
2
Primary Endpoint
Satiety
Status
Withdrawn
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
October 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Heather Blewett

Principal Investigator

St. Boniface Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Satiety

Time Frame: 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

Time Frame: 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 Outcomes

  • Glucose and Insulin(before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.)
  • Kilocalories(1 day)

Study Sites (2)

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