Metabolic Health Benefits of Dairy Protein
Primary Purpose
Hyperlipidemia, Obesity
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
High Dairy
Sponsored by
About this trial
This is an interventional screening trial for Hyperlipidemia focused on measuring body weight, lipids, glucose, insulin
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).
Sites / Locations
- Richardson Centre for Functional Foods and Nutraceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
High Dairy
Control, Low Dairy
Arm Description
Consuming four or more servings of dairy per day.
Participants consumed less than 2 servings of low fat dairy per day.
Outcomes
Primary Outcome Measures
markers of metabolic (cardiometabolic) health
total body composition (% body fat)
blood lipids, blood glucose
blood pressure
insulin sensitivity
resting metabolic rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01761955
Brief Title
Metabolic Health Benefits of Dairy Protein
Official Title
Metabolic Health Benefits of Dairy Protein
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Obesity
Keywords
body weight, lipids, glucose, insulin
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dairy
Arm Type
Experimental
Arm Description
Consuming four or more servings of dairy per day.
Arm Title
Control, Low Dairy
Arm Type
Placebo Comparator
Arm Description
Participants consumed less than 2 servings of low fat dairy per day.
Intervention Type
Other
Intervention Name(s)
High Dairy
Intervention Description
Consuming 4 or more servings of dairy products per day for a period of 6 months
Primary Outcome Measure Information:
Title
markers of metabolic (cardiometabolic) health
Description
total body composition (% body fat)
blood lipids, blood glucose
blood pressure
insulin sensitivity
resting metabolic rate
Time Frame
Six Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Rempel, PhD, MBA
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Fulcher, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter JH Jones, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rotimi Aluko, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Netticadan, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Chair
Facility Information:
Facility Name
Richardson Centre for Functional Foods and Nutraceuticals
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23638799
Citation
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.
Results Reference
derived
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Metabolic Health Benefits of Dairy Protein
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