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

NCT01444326 | Completed

• 1 other identifier: INAF-2010-155
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Keywords

Keywords;; Cardiovascular disease; Dairy; Inflammation; Blood lipids

Outcome Measures

Primary Outcomes (1)

• Change in plasma CRP concentrations

  At the beginning of the study and the end of the two 4-week diets

Secondary Outcomes (6)

• Change in endothelial function

  At the end of the two 4-week diets

• Change in plasma lipid concentrations (LDL-Cholesterol, HDL-C, triglycerides)

  At the beginning of the study and the end of the two 4-week diets

• Change in insulin levels

  At the beginning of the study and the end of the two 4-week diets

• Change in anthropometric measures (waist and hip circumferences)

  At the beginning of the study and the end of the two 4-week diets

• Change in blood pressure

  At the begining of the study and the end of the two 4-week diets

Study Arms (2)

Dairy diet

EXPERIMENTAL

Other: Dairy

Control diet

PLACEBO COMPARATOR

Other: Dairy

Interventions

Dairy OTHER

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).

Also known as: Dairy products, milk, cheese, yogourt

Control diet; Dairy diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (2)

• Abdullah MM, Cyr A, Lepine MC, Eck PK, Couture P, Lamarche B, Jones PJ. Common Variants in Cholesterol Synthesis- and Transport-Related Genes Associate with Circulating Cholesterol Responses to Intakes of Conventional Dairy Products in Healthy Individuals. J Nutr. 2016 May;146(5):1008-16. doi: 10.3945/jn.115.222208. Epub 2016 Apr 6.

  PMID: 27052530 DERIVED

• Labonte ME, Cyr A, Abdullah MM, Lepine MC, Vohl MC, Jones P, Couture P, Lamarche B. Dairy product consumption has no impact on biomarkers of inflammation among men and women with low-grade systemic inflammation. J Nutr. 2014 Nov;144(11):1760-7. doi: 10.3945/jn.114.200576. Epub 2014 Sep 3.

  PMID: 25332474 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

Dairy Products; Milk; Cheese

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Cultured Milk Products; Fermented Foods

Study Officials

• Benoît Lamarche, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

CA (1)