Metabolic Health Benefits of Dairy Protein

• ClinicalTrials.gov Identifier: NCT01761955
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Last Update Posted: January 10, 2013
• Sponsor: University of Manitoba
• Information provided by (Responsible Party): University of Manitoba

Tracking Information

• First Submitted Date: May 22, 2012
• First Posted Date: January 7, 2013
• Last Update Posted Date: January 10, 2013
• Study Start Date: February 2009
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2013)

markers of metabolic (cardiometabolic) health [ Time Frame: Six Months ]

• total body composition (% body fat)
• blood lipids, blood glucose
• blood pressure
• insulin sensitivity
• resting metabolic rate

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Metabolic Health Benefits of Dairy Protein
• Official Title: Metabolic Health Benefits of Dairy Protein
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Screening

Condition

• Hyperlipidemia
• Obesity

Intervention

Other: High Dairy

Consuming 4 or more servings of dairy products per day for a period of 6 months

Study Arms

• Experimental: High Dairy
  Consuming four or more servings of dairy per day.
  Intervention: Other: High Dairy
• Placebo Comparator: Control, Low Dairy
  Participants consumed less than 2 servings of low fat dairy per day.

• Publications *: Rideout TC, Marinangeli CP, Martin H, Browne RW, Rempel CB. Consumption of low-fat dairy foods for 6 months improves insulin resistance without adversely affecting lipids or bodyweight in healthy adults: a randomized free-living cross-over study. Nutr J. 2013 May 2;12:56. doi: 10.1186/1475-2891-12-56.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2013): 21
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• BMI ≥25 kg/m2, assessed as age-related healthy based on pre-study screening examination including:

  • medical history
  • diet and lifestyle history
  • physical measurements (height, weight and blood pressure).

Exclusion Criteria:

• Pregnancy or likely to be pregnant (ionizing radiation from DEXA)
• Weight ≥135kg (exceeds the capacity of the DEXA scanner)diagnosed diabetes or cardiovascular disease
• Liver or renal disease
• Regular use of appetite suppressants
• Irregular use of other treatments which might interfere with the outcomes of the study (e.g anti-hypertensives, statins, thyroxine, omega-3 supplements etc).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01761955
• Other Study ID Numbers: J2008:075
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Manitoba
• Study Sponsor: University of Manitoba
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: University of Manitoba
• Verification Date: December 2008