Clinical trial NCT01761955: Metabolic Health Benefits of Dairy Protein
Official title: Metabolic Health Benefits of Dairy Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Obesity
Keywords: body weight
lipids
glucose
insulin
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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).

Primary outcomes:
measure: markers of metabolic (cardiometabolic) health
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Curtis Rempel, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Gary Fulcher, PhD
role: STUDY_CHAIR
affiliation: University of Manitoba
name: Peter JH Jones, PhD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Rotimi Aluko, PhD
role: STUDY_CHAIR
affiliation: University of Manitoba
name: Thomas Netticadan, PhD
role: STUDY_CHAIR
References:
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.