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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491814
• Other study ID #: DFC_31012
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 27, 2015
• Last updated: July 2, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy BMI (20.0 - 24.9 kg/m2)

• Females with regular monthly menstrual cycles

Exclusion Criteria:

• Diabetes

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Other:
• 1% M.F. Milk

• Yogurt Beverage

• Soy Beverage

• Almond Beverage

• Water

• Breakfast cereal

Locations

Country	Name	City	State
Canada	Department of Nutritional Sciences, FitzGerald Building	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Dairy Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose	Blood glucose (mmol/L) is measured using finger prick capillary blood samples	0-170 minutes	No
Primary	Subjective Appetite	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	No
Secondary	Insulin	Blood insulin (µU/mL) is measured using finger prick capillary blood samples	0-170 minutes	No
Secondary	Food Intake	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	No