- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491814
The Effect of Dairy and Non-dairy Alternatives on Satiety and Post-meal Glycemia in Healthy Young Adults
The Effect of Commercially-available Dairy and Non-dairy Alternatives When Consumed With a High Glycemic Cereal on Subjective Appetite Ratings and Post-meal Glycemia in Healthy Young Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Regular consumption of dairy is associated with better body composition and lower incidences of type 2 diabetes and obesity. This may be due to dairy's ability to increase satiety and decrease post-prandial glycemia. However, most clinical studies have only investigated isolated dairy proteins (whey and casein) and the effects of whole dairy products remains unclear. Additionally, as non-dairy alternatives are becoming more popular there is interest to see if they can elicit similar benefits as dairy. Therefore, this study will test the effects of commercially-available dairy and non-dairy beverages when consumed with cereal at breakfast time.
Thirty healthy young males and females (20-30 years, BMI 20.0-24.9 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 250 mL of 1% milk, soy beverage, almond beverage, yogurt beverage, or water with 54 g of Cheerios cereal. At 0 (baseline), 15, 30, 45, 60, 75, 90, 120 minutes (pre-meal period) 140, and 170 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes and for the last two timepoints. Between 120-140 minutes, an ad libitum lunch will be provided to assess food intake.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5S 3E2
- Department of Nutritional Sciences, FitzGerald Building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy BMI (20.0 - 24.9 kg/m2)
- Females with regular monthly menstrual cycles
Exclusion Criteria:
- Diabetes
- Fasting blood glucose higher than 5.8 mmol/L
- Pregnancy
- Medications
- Smoking
- Lactose intolerance or allergies to milk, soy, or almonds
- Elite athletes
- Those trying to lose or gain weight
- Breakfast skippers and those on an energy-restricted diet
- Score equal to or higher than 11 on Eating Habits Questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1% M.F. Milk and Breakfast Cereal
Breakfast meal: 250 ml 1% M.F.
Milk, 54 g Cheerios breakfast cereal, 100 mL water
|
Other Names:
Other Names:
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Experimental: Yogurt Beverage and Breakfast Cereal
Breakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water
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Other Names:
Other Names:
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Experimental: Soy Beverage and Breakfast Cereal
Breakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water
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Other Names:
Other Names:
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Experimental: Almond Beverage and Breakfast Cereal
Breakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water
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Other Names:
Other Names:
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Experimental: Water (control) and Breakfast Cereal
Breakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Glucose
Time Frame: 0-170 minutes
|
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
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0-170 minutes
|
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Subjective Appetite
Time Frame: 0-170 minutes
|
Subjective appetite ratings are obtained from four 100 mm visual analogue scale (VAS) questions assessing "Desire to Eat", "Hunger", "Fullness" and "Prospective Food Consumption".
The average of all four VAS is calculated to obtain the average appetite score for statistical analysis
|
0-170 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin
Time Frame: 0-170 minutes
|
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
|
0-170 minutes
|
|
Food Intake
Time Frame: 120-140 minutes
|
Food at an ad libitum pizza lunch will be weighed to determine food intake based on nutrition information provided by the pizza manufacturer
|
120-140 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: G. Harvey Anderson, Ph.D., Department of Nutritional Sciences, University of Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DFC_31012
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