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Completed

NCT Number: NCT02607007

The Effect of Dairy and Non-dairy Breakfasts on Satiety 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.

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Key information

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Nutritional Sciences, University of Toronto

Toronto, Ontario, M5S 3E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% M.F. Milk

Other

Other names: 2% cow's milk, Neilsen Canada, White milk

White Bread

Other

Other names: White toast, Wonder Bread Canada

Strawberry Jam

Other

Other names: Pure strawberry jam (not seedless), Fruit jam, Smucker's

31% M.F. Cheddar Cheese

Other

Other names: Mild cheddar cheese, Hard cheese, Armstrong Canada

2% M.F. Plain Greek yogurt

Other

Other names: Yogurt, Oikos, Danone Canada

Soy Beverage

Other

Other names: Soy milk, Non-dairy alternative, So Good, Vanilla

Water

Other

Other names: Calorie-free control

Primary outcomes

  1. Blood Glucose

    Time frame: 0-210 minutes

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

  2. 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.

Secondary outcomes

  1. Insulin

    Time frame: 0-210 minutes

    Blood insulin (μU/mL) is measured using finger prick capillary blood samples

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Dairy Farmers of Canada

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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