Metabolic Health Benefits of Dairy Protein

Obesity Clinical Trial

Official title:

Metabolic Health Benefits of Dairy Protein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761955
• Other study ID #: J2008:075
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2012
• Last updated: January 9, 2013
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: December 2008
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Obesity

Intervention

Other:
• High Dairy
Consuming 4 or more servings of dairy products per day for a period of 6 months

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	markers of metabolic (cardiometabolic) health	total body composition (% body fat); blood lipids, blood glucose; blood pressure; insulin sensitivity; resting metabolic rate	Six Months	No