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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemia; Obesity	Other: High Dairy	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Metabolic Health Benefits of Dairy Protein
• Study Start Date: February 2009
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

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):

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.

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT01761955 History of Changes
• Other Study ID Numbers: J2008:075
• 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; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases