Metabolic Health Benefits of Dairy Protein

NCT ID: NCT01761955

Last Updated: 2013-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-05-31

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.

Conditions

Hyperlipidemia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

High Dairy

Consuming four or more servings of dairy per day.

Group Type: EXPERIMENTAL

High Dairy

Intervention Type: OTHER

Consuming 4 or more servings of dairy products per day for a period of 6 months

Control, Low Dairy

Participants consumed less than 2 servings of low fat dairy per day.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

High Dairy

Consuming 4 or more servings of dairy products per day for a period of 6 months

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtis Rempel, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Gary Fulcher, PhD

Role: STUDY_CHAIR

University of Manitoba

Peter JH Jones, PhD

Role: STUDY_DIRECTOR

University of Manitoba

Rotimi Aluko, PhD

Role: STUDY_CHAIR

University of Manitoba

Thomas Netticadan, PhD

Role: STUDY_CHAIR

University of Manitoba

Locations

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 23638799 (View on PubMed)

Other Identifiers

J2008:075

Identifier Type: -

Identifier Source: org_study_id