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

May 10, 2016 updated by: G. Harvey Anderson, University of Toronto

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 3E2
        • Department of Nutritional Sciences, FitzGerald Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • 1% cow's milk
  • Neilsen Canada
Other Names:
  • Cheerios, General Mills
Experimental: Yogurt Beverage and Breakfast Cereal
Breakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Other Names:
  • Cheerios, General Mills
Other Names:
  • Yop (Vanilla), General Mills
Experimental: Soy Beverage and Breakfast Cereal
Breakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Other Names:
  • Cheerios, General Mills
Other Names:
  • Soy Milk
  • Silk Organic Original
Experimental: Almond Beverage and Breakfast Cereal
Breakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Other Names:
  • Cheerios, General Mills
Other Names:
  • Almond Milk
  • Silk Original
Experimental: Water (control) and Breakfast Cereal
Breakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water
Other Names:
  • Calorie-free control
Other Names:
  • Cheerios, General Mills

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
0-170 minutes
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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: G. Harvey Anderson, Ph.D., Department of Nutritional Sciences, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

July 2, 2015

First Posted (Estimate)

July 8, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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