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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02607007
• Other study ID #: DFC_31936
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 13, 2015
• Last updated: November 13, 2015
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: November 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 70 Years

Eligibility

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 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:
• 2% M.F. Milk

• White Bread

• Strawberry Jam

• 31% M.F. Cheddar Cheese

• 2% M.F. Plain Greek yogurt

• Soy Beverage

• Water

Locations

Country	Name	City	State
Canada	Department of Nutritional Sciences, University of Toronto	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	0-210 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.	0-210 minutes	No
Secondary	Insulin	Blood insulin (µU/mL) is measured using finger prick capillary blood samples	0-210 minutes	No
Secondary	Food Intake	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	No