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

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

The Effect of Dairy and Non-dairy Breakfasts on Subjective Appetite Ratings, Food Intake, and Post-meal Glycemia in Healthy Older Adults

This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt, cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study.

Study Overview

Status

Completed

Conditions

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, consumed as part of a meal, remain unclear. Additionally, the effect of dairy type and form remain to be further investigated. Therefore, this study will test the effects of dairy products when consumed with a high glycemic index breakfast on satiety and post-prandial glycemia.

Thirty healthy older males and females (60-70 years, BMI 18.5-30.0 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 1) 2% milk (250 mL), 2) soy beverage (250 mL), 3) plain 2% Greek yogurt (175 g), 4) cheddar cheese (30 g), or 5) water (250 mL - control). Treatments will be consumed along with 2 pieces of white toast with strawberry jam, except for the water control which will be consumed alone. All breakfast meals will be isocaloric and water will be given with the yogurt (75 mL) and cheese (220 mL) to compensate for fluid content. At 0 (baseline), 15, 30, 45, 60, 90, 120, 150, 180, (pre-meal period) and 210 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes. Between 180-200 minutes, an ad libitum lunch will be provided to assess food intake.

Study Type

Interventional

Enrollment (Actual)

29

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

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

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

60 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy BMI (18.5-30.0 kg/m2)
  • Regular breakfast consumers
  • Menopausal for at least 1 year (females)

Exclusion Criteria:

  • Smoking
  • Diabetes
  • Fasting blood glucose equal to or higher than 6.0 mmol/L
  • Cardiovascular disease
  • Medication affecting appetite or metabolism
  • Trying to lose or gain weight through a diet or exercise regime
  • Lactose intolerance or allergies to study foods
  • 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: 2% M.F. Milk
Breakfast meal: 250 mL 2% M.F. milk, 75 g white toast, 23.2 g strawberry jam, 100 mL water
Other: 2% M.F. Milk
Other Names:
  • Neilsen Canada
  • 2% cow's milk
  • White milk
Other: White Bread
Other Names:
  • White toast
  • Wonder Bread Canada
Other: Strawberry Jam
Other Names:
  • Pure strawberry jam (not seedless)
  • Fruit jam
  • Smucker's
Experimental: 2% M.F. Plain Greek Yogurt
Breakfast meal: 175 g 2% plain Greek yogurt, 75 g white toast, 23.2 g strawberry jam, 100 mL + 75 mL water
Other: White Bread
Other Names:
  • White toast
  • Wonder Bread Canada
Other: Strawberry Jam
Other Names:
  • Pure strawberry jam (not seedless)
  • Fruit jam
  • Smucker's
Other: 2% M.F. Plain Greek yogurt
Other Names:
  • Yogurt
  • Oikos, Danone Canada
Experimental: 31% M.F. Cheddar Cheese
Breakfast meal: 30 g 31% M.F. cheddar cheese, 75 g white toast, 27.0 g strawberry jam, 100 mL + 220 mL water
Other: White Bread
Other Names:
  • White toast
  • Wonder Bread Canada
Other: Strawberry Jam
Other Names:
  • Pure strawberry jam (not seedless)
  • Fruit jam
  • Smucker's
Other: 31% M.F. Cheddar Cheese
Other Names:
  • Mild cheddar cheese
  • Hard cheese
  • Armstrong Canada
Experimental: Soy Beverage
Breakfast meal: 250 mL soy beverage, 75 g white toast, 19.3 g strawberry jam, 100 mL water
Other: Soy Beverage
Other Names:
  • Soy milk
  • Non-dairy alternative
  • So Good, Vanilla
Other: White Bread
Other Names:
  • White toast
  • Wonder Bread Canada
Other: Strawberry Jam
Other Names:
  • Pure strawberry jam (not seedless)
  • Fruit jam
  • Smucker's
Experimental: Water (control)
Breakfast meal: 250 mL + 100 mL water
Other: Water
Other Names:
  • Calorie-free control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose
Time Frame: 0-210 minutes
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
0-210 minutes
Subjective Appetite
Time Frame: 0-210 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.
0-210 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin
Time Frame: 0-210 minutes
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
0-210 minutes
Food Intake
Time Frame: 180-200 minutes
Food at an ad libitum lunch meal consisting of a dish of rice, meatballs, and tomato sauce will be weighed to determine food intake based on nutrition information provided by the manufacturers.
180-200 minutes

Collaborators and Investigators

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

Sponsor

University of Toronto

Collaborators

Dairy Farmers of Canada

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

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (Estimate)

November 17, 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

Keywords

Other Study ID Numbers

  • DFC_31936

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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