Clinical trial NCT02111486: Effect of Certain Breakfasts on Appetite Control
Official title: A Randomized, Controlled, Cross-over Study of the Effect of Certain Breakfasts on Appetite Control.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Appetite
Post-prandial Glucose Response
Keywords: Breakfast
Satiety
Fibre
Glucose
Gastric emptying
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2014-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Satiety
timeFrame: before the breakfast and every 30 minutes after breakfast for 4 hours
measure: Gastric emptying rate
timeFrame: before the breakfast and every 15 minutes after breakfast for 4 hours
Secondary outcomes:
measure: Glucose and Insulin
timeFrame: before the breakfast and at 15, 30, 45, 60, 90 and 120 minutes after the the breakfast.
measure: Kilocalories
timeFrame: 1 day
Other outcomes:
measure: Gastrointestinal side effects
timeFrame: 4 weeks
Locations:
city: Winnipeg
country: Canada
facility: I.H. Asper Clinical Research Institute
state: Manitoba
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: I.H. Asper Clinical Research Institute/Agriculture and Agri-Food Canada
name: Heather Blewett, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Richardson Centre for Functional Foods and Nutraceuticals/Agriculture and Agri-Food Canada
name: Nancy Ames, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.