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Metabolic Health Benefits of Dairy Protein

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761955
First Posted: January 7, 2013
Last Update Posted: January 10, 2013
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.
Information provided by (Responsible Party):
University of Manitoba
  Purpose
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.

Condition Intervention Phase
Hyperlipidemia Obesity Other: High Dairy Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Metabolic Health Benefits of Dairy Protein

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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


Enrollment: 21
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761955


Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01761955     History of Changes
Other Study ID Numbers: J2008:075
First Submitted: May 22, 2012
First Posted: January 7, 2013
Last Update Posted: January 10, 2013
Last Verified: December 2008

Keywords provided by University of Manitoba:
body weight
lipids
glucose
insulin

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases