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

NCT02607007 | Completed Phase 1

• 1 other identifier: DFC_31936
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Obesity

Keywords

Dairy; Post-prandial Glycemia; Satiety; Food Intake; Insulin; Milk; Greek yogurt; Cheese; Soy beverage

Outcome Measures

Primary Outcomes (2)

• Blood Glucose

  Blood glucose (mmol/L) is measured using finger prick capillary blood samples

  0-210 minutes

• 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.

  0-210 minutes

Secondary Outcomes (2)

• Insulin

  0-210 minutes

• Food Intake

  180-200 minutes

Study Arms (5)

2% M.F. Milk

EXPERIMENTAL

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: White Bread; Other: Strawberry Jam

2% M.F. Plain Greek Yogurt

EXPERIMENTAL

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: Strawberry Jam; Other: 2% M.F. Plain Greek yogurt

31% M.F. Cheddar Cheese

EXPERIMENTAL

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: Strawberry Jam; Other: 31% M.F. Cheddar Cheese

Soy Beverage

EXPERIMENTAL

Breakfast meal: 250 mL soy beverage, 75 g white toast, 19.3 g strawberry jam, 100 mL water

Other: White Bread; Other: Strawberry Jam; Other: Soy Beverage

Water (control)

EXPERIMENTAL

Breakfast meal: 250 mL + 100 mL water

Other: Water

Interventions

2% M.F. Milk OTHER

Also known as: 2% cow's milk, Neilsen Canada, White milk

2% M.F. Milk

White Bread OTHER

Also known as: White toast, Wonder Bread Canada

2% M.F. Milk; 2% M.F. Plain Greek Yogurt; 31% M.F. Cheddar Cheese; Soy Beverage

Strawberry Jam OTHER

Also known as: Pure strawberry jam (not seedless), Fruit jam, Smucker's

2% M.F. Milk; 2% M.F. Plain Greek Yogurt; 31% M.F. Cheddar Cheese; Soy Beverage

31% M.F. Cheddar Cheese OTHER

Also known as: Mild cheddar cheese, Hard cheese, Armstrong Canada

31% M.F. Cheddar Cheese

2% M.F. Plain Greek yogurt OTHER

Also known as: Yogurt, Oikos, Danone Canada

2% M.F. Plain Greek Yogurt

Soy Beverage OTHER

Also known as: Soy milk, Non-dairy alternative, So Good, Vanilla

Soy Beverage

Water OTHER

Also known as: Calorie-free control

Water (control)

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

Department of Nutritional Sciences, University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Insulin Resistance

Interventions

Milk; Yogurt; Soy Milk; Water

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Cultured Milk Products; Fermented Foods; Milk Substitutes; Soy Foods; Vegetable Products; Vegetables; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• G. Harvey Anderson, Ph.D.

  Department of Nutritional Sciences, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 17, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

CA (1)