Appetite, Post-prandial Glucose Response
Conditions
Keywords
Breakfast, Satiety, Fibre, Glucose, Gastric emptying
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).
Interventions
OTHERbreakfast
Sponsors
Agriculture and Agri-Food Canada
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Kilocalories | 1 day | Measure the amount of kilocalories consumed throughout each test day. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal side effects | 4 weeks | Incidence and duration of gastrointestinal side effects. |
Countries
Canada
Outcome results
None listed