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

This study has been completed.
Sponsor:
Collaborator:
Dairy Farmers of Canada
Information provided by (Responsible Party):
Benoit Lamarche, Laval University
ClinicalTrials.gov Identifier:
NCT01444326
First received: September 28, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Other: Dairy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Dairy Consumption on Inflammation: a Clinical Study

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change in plasma CRP concentrations [ Time Frame: At the beginning of the study and the end of the two 4-week diets ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in endothelial function [ Time Frame: At the end of the two 4-week diets ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in insulin levels [ Time Frame: At the beginning of the study and the end of the two 4-week diets ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: At the begining of the study and the end of the two 4-week diets ] [ Designated as safety issue: No ]
  • Change in CRP intravascular kinetics (in a subsample of the entire study population) [ Time Frame: At the end of the two 4-week diets ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: March 2010
Study Completion Date: December 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Dairy products, milk, cheese, yogourt

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444326

Locations
Canada
Institute of Nutraceutical and Functional Foods (INAF), Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Dairy Farmers of Canada
Investigators
Principal Investigator: Benoît Lamarche, PhD Laval University
  More Information

No publications provided

Responsible Party: Benoit Lamarche, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01444326     History of Changes
Other Study ID Numbers: INAF-2010-155
Study First Received: September 28, 2011
Last Updated: April 1, 2014
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Keywords;
Cardiovascular disease
Dairy
Inflammation
Blood lipids

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014