Metabolic Health Benefits of Dairy Protein

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metabolic Health Benefits of Dairy Protein

Conditions
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Hyperlipidemia, Obesity

Intervention / Treatment
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* Other: High Dairy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dairy<br>Consuming four or more servings of dairy per day. | Other: High Dairy<br>* Consuming 4 or more servings of dairy products per day for a period of 6 months<br>|
| Placebo Comparator: Control, Low Dairy<br>Participants consumed less than 2 servings of low fat dairy per day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers of metabolic (cardiometabolic) health | total body composition (% body fat) blood lipids, blood glucose blood pressure insulin sensitivity resting metabolic rate | Six Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body weight, lipids, glucose, insulin