Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metabolic Health Benefits of Dairy Protein

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761955
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE May 22, 2012
First Posted Date  ICMJE January 7, 2013
Last Update Posted Date January 10, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Health Benefits of Dairy Protein
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Hyperlipidemia
  • Obesity
Intervention  ICMJE Other: High Dairy
Consuming 4 or more servings of dairy products per day for a period of 6 months
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761955
Other Study ID Numbers  ICMJE J2008:075
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP