Impact of Dairy Consumption on Inflammation: a Clinical Study (PLI) (PLI)

April 1, 2014 updated by: Benoit Lamarche, Laval University

Impact of Dairy Consumption on Inflammation: a Clinical Study

Inflammation and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). These pro-atherogenic states are strongly correlated and often found co-segregating among individuals with obesity and the metabolic syndrome. There is increasing evidence to support the use in clinical practice of these novel markers of atherosclerosis and CVD risk. Recent data from the JUPITER study (Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin) has provided undisputable evidence that treating patients with elevated plasma CRP concentrations, a marker of systemic subclinical inflammation, leads to marked reduction in the risk of CHD even in patients with highly desirable LDL-C levels. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to an increased risk of CVD. While there are more and more studies on how diet affects inflammation and endothelial function, the impact of dairy consumption per se on these novel risk factors for CVD has not been well characterized.

The purpose of this study was to investigate the impact of dairy consumption on markers of inflammation and other risk factors in men and women with low grade systemic inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research will be undertaken as a multicenter randomized cross-over controlled study. A total of 140 men and women with subclinical inflammation (plasma CRP 2-10 mg/l) but otherwise healthy will consume two diets, one rich in dairy and one without dairy, while consuming a diet low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (milk, yogurt, cheese) into their every day diet. During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products. Each diet will be undertaken consecutively in random order and will have duration of approximately 28 days each (4 weeks).The primary analysis consists in comparing inflammation markers and related risk factors between the two treatments. The study is designed to detect a 12-16% difference in plasma CRP concentrations (the primary endpoint) between the control and the dairy diet.

A 2-week stabilization run-in period will precede the randomization of participants. During this run-in period, participants will be asked and instructed to adapt their diet to a prudent dietary pattern low in saturated fat (<10% energy), in trans fat (<1% energy) and in cholesterol (<200 mg/day). The total amount of fat in the diet will not be restricted, with recommendations ranging from 25-35% of energy. However, substitution of saturated for unsaturated fat will be advocated. Sodium intake <2300 mg/d will also be recommended. Recommendations will also include advice on how to restrict the consumption of processed and energy dense foods. The run-in diet will not include specific recommendation on dairy products. Participants will have the choice to include/exclude dairy from their prudent diet, as long as they comply with the main dietary recommendations. This 2-week run-in period will allow participants to familiarize themselves with the dietary recommendations used during the intervention per se. The two diets will be separated by a 4-week wash out period and will also consist to the prudent dietary pattern recommended. It must be stressed that foods will not be provided during the run-in and wash-out periods. These periods are imposed to minimize the inter- and intra-individual variability before and between the experimental phases.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 0A6
        • Institute of Nutraceutical and Functional Foods (INAF), Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged between 18 and 70 years
  • Presenting a subclinical inflammation (Plasma CRP >2 and <10 mg/l)
  • Abdominal obesity, waist girth >94 cm in men and >80 cm in women
  • Consumption of dairy products fewer than 2 servings per day
  • Pre-menopausal women with regular menstrual cycle for the last 3 months

Exclusion Criteria:

  • Plasma CRP <2 or >10 mg/l
  • Smokers (>1 cigarette/day)
  • Body weight variation >10% for the last 6 months prior to the study baseline
  • BMI >35 kg/m2
  • Previous history of CVD, type 2 diabetes and monogenic dyslipidemia
  • Subjects taking medications for hyperlipidemia, hypertension
  • Post menopausal women who have initiated hormone replacement therapy within 6 months of study onset
  • Endocrine or gastrointestinal disorders
  • Smoking
  • Food allergies, milk aversion or intolerant to lactose
  • Clinical use of vitamin D or calcium supplements
  • Vegetarianism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dairy diet
Other: Dairy

During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (375 ml of milk, 175 g of yogurt, 30 g of cheese) into their every day diet.

During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products (375 ml of fruit juice, 1 homemade cookie, 20 g of cashew).

Other Names:
  • Dairy products, milk, cheese, yogourt
Placebo Comparator: Control diet
Other: Dairy

During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (375 ml of milk, 175 g of yogurt, 30 g of cheese) into their every day diet.

During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products (375 ml of fruit juice, 1 homemade cookie, 20 g of cashew).

Other Names:
  • Dairy products, milk, cheese, yogourt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in plasma CRP concentrations
Time Frame: At the beginning of the study and the end of the two 4-week diets
At the beginning of the study and the end of the two 4-week diets

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in endothelial function
Time Frame: At the end of the two 4-week diets
At the end of the two 4-week diets
Change in plasma lipid concentrations (LDL-Cholesterol, HDL-C, triglycerides)
Time Frame: At the beginning of the study and the end of the two 4-week diets
At the beginning of the study and the end of the two 4-week diets
Change in insulin levels
Time Frame: At the beginning of the study and the end of the two 4-week diets
At the beginning of the study and the end of the two 4-week diets
Change in anthropometric measures (waist and hip circumferences)
Time Frame: At the beginning of the study and the end of the two 4-week diets
At the beginning of the study and the end of the two 4-week diets
Change in blood pressure
Time Frame: At the begining of the study and the end of the two 4-week diets
At the begining of the study and the end of the two 4-week diets
Change in CRP intravascular kinetics (in a subsample of the entire study population)
Time Frame: At the end of the two 4-week diets
At the end of the two 4-week diets

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Dairy Farmers of Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INAF-2010-155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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