The Effect of Dairy and Non-dairy Alternatives on Satiety and Post-meal Glycemia in Healthy Young Adults

Phase 1

Completed

• Conditions: Diabetes; Obesity
• Interventions: Other: Water; Other: 1% M.F. Milk; Other: Yogurt Beverage; Other: Soy Beverage; Other: Almond Beverage; Other: Breakfast cereal

• Registration Number: NCT02491814
• Lead Sponsor: University of Toronto

Brief Summary

This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt beverage) and non-dairy alternatives (almond and soy beverages) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study.

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-27
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1% M.F. Milk and Breakfast Cereal	Breakfast cereal	Breakfast meal: 250 ml 1% M.F. Milk, 54 g Cheerios breakfast cereal, 100 mL water
Soy Beverage and Breakfast Cereal	Breakfast cereal	Breakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Almond Beverage and Breakfast Cereal	Breakfast cereal	Breakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Water (control) and Breakfast Cereal	Water	Breakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water
Water (control) and Breakfast Cereal	Breakfast cereal	Breakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water
1% M.F. Milk and Breakfast Cereal	1% M.F. Milk	Breakfast meal: 250 ml 1% M.F. Milk, 54 g Cheerios breakfast cereal, 100 mL water
Yogurt Beverage and Breakfast Cereal	Yogurt Beverage	Breakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Yogurt Beverage and Breakfast Cereal	Breakfast cereal	Breakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Soy Beverage and Breakfast Cereal	Soy Beverage	Breakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Almond Beverage and Breakfast Cereal	Almond Beverage	Breakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water

Primary Outcome Measures

Name	Time	Method
Blood Glucose	0-170 minutes	Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Subjective Appetite	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

Secondary Outcome Measures

Name	Time	Method
Food Intake	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
Insulin	0-170 minutes	Blood insulin (μU/mL) is measured using finger prick capillary blood samples

Trial Locations

Locations (1)

Department of Nutritional Sciences, FitzGerald Building; 🇨🇦 Toronto, Ontario, Canada