Metabolic Health Benefits of Dairy Protein
The purpose of this study is to evaluate the effects of regular low fat diary consumption on markers of cardiovascular (CV) and metabolic (cardiometabolic) health including body composition (% body fat, body weight), blood lipids, blood glucose, arterial compliance, blood pressure, insulin sensitivity and resting metabolic rate.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Metabolic Health Benefits of Dairy Protein|
- markers of metabolic (cardiometabolic) health [ Time Frame: Six Months ] [ Designated as safety issue: No ]
- total body composition (% body fat)
- blood lipids, blood glucose
- blood pressure
- insulin sensitivity
- resting metabolic rate
|Study Start Date:||February 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: High Dairy
Consuming four or more servings of dairy per day.
Other: High Dairy
Consuming 4 or more servings of dairy products per day for a period of 6 months
Placebo Comparator: Control, Low Dairy
Participants consumed less than 2 servings of low fat dairy per day.
This is a multi-centre, randomized, dietary intervention study of 12 months. A total of 100 overweight/obese individuals will be recruited, half recruited in Adelaide, South Australia and the other half from Manitoba, Canada. At baseline, subjects assigned to HD will be given standard serves of low fat dairy products (eg. 250mL milk, 200g yoghurt) on a regular basis for 6 months and asked to incorporate 4 serves/day into their diet. Volunteers randomized to the LD will be asked to continue with their habitual diet and consume less than 2 serves of dairy on a regular basis for 6 months. All participants will be asked to complete a food frequency questionnaire, physical activity diary, 3-day food record, and keep a record of dairy serves (food log) consumed each day. In total, participants will be asked to come to the centre 5 times throughout the study. However, the HD group will be asked to return to the centre every two weeks to receive diary product and return dairy record (food log). At baseline subjects will be asked to attend the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) fasted for various measurements including: body weight, blood pressure, arterial compliance, dual energy x-ray absorptiometry (DEXA) scan for measurement of body fat, abdominal fat and bone mineral density, waist and hip circumferences and provide a blood sample for the measurement of blood lipids, insulin and glucose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761955
|Richardson Centre for Functional Foods and Nutraceuticals|
|Winnipeg, Manitoba, Canada, R3T 2N2|
|Principal Investigator:||Curtis Rempel, PhD, MBA||University of Manitoba|
|Study Chair:||Gary Fulcher, PhD||University of Manitoba|
|Study Director:||Peter JH Jones, PhD||University of Manitoba|
|Study Chair:||Rotimi Aluko, PhD||University of Manitoba|
|Study Chair:||Thomas Netticadan, PhD||University of Manitoba|