Impact of Dairy Consumption on Hypertension: a Clinical Study

NCT01776216 | Completed

• 1 other identifier: INAF-C11-02-163
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension and endothelial dysfunction are being increasingly recognized as key etiological factors in the development of atherosclerosis and subsequent cardiovascular disease (CVD). A substantial body of evidence indicates that treating patients with elevated blood pressure (BP) leads to marked reduction in the risk of stroke, myocardial infarction, heart failure, and renal failure. There is also accumulating evidence associating endothelial dysfunction, which is defined as incapacity of the arteries to vasodilate when required, to elevated BP and an increased risk of CVD. While there are more and more studies on how diet affects BP in healthy subjects, the impact of dairy consumption per se on both endothelial function and ambulatory BP has not been well characterized in patients with established essential hypertension. Therefore, the general objective of the study is to investigate in a single-blind randomized controlled study the impact of dairy consumption on ambulatory BP and endothelial function in subjects with mild to moderate essential hypertension.

Conditions

Hypertension; Cardiovascular Diseases

Keywords

Endothelial function; Dairy

Outcome Measures

Primary Outcomes (1)

• Change in mean daytime systolic blood pressure

  Mean daytime systolic blood pressure will be measured by 24-h ambulatory blood pressure monitoring using the Spacelabs 90207 (Spacelabs, Inc., Redmond, WA)

  At the fisrt visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)

Secondary Outcomes (2)

• Change in mean daytime diastolic blood pressure

  At the first visit of the study (screening) and at the end of the two 4-weeks diets (week 4 and week 12)

• Change in endothelial function

  At the end of the two 4-weeks diets (week 4 and week 12)

Study Arms (2)

Dairy diet

EXPERIMENTAL

During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy into their everyday diet.

Other: Dairy diet

Control diet

PLACEBO COMPARATOR

During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products into their everyday diet.

Other: Control diet

Interventions

Dairy diet OTHER

During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy: 375 ml of reduced fat milk (1% fat), 175 g of low fat yogurt (1.5% fat) and 30g of regular cheese (34% fat) into their every day diet.

Also known as: Dairy products, Milk, Yogourt, Cheese

Dairy diet

Control diet OTHER

During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products (290 ml of fruit juice, 156 ml of vegetable juice, 1 homemade cookie, 20g of cashew).

Control diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 18 and 70 years
• Mean daytime systolic blood pressure ≥ 135 mm Hg and ≤ 160 mm Hg
• Mean daytime diastolic blood pressure ≤ 110 mm Hg
• Consumption of dairy products fewer than 2 servings per day

You may not qualify if:

• Mean daytime systolic blood pressure \> 160 mm Hg
• Mean daytime diastolic blood pressure \> 110 mm Hg
• Dairy intake \> 2 serving per day
• Smokers (\>1 cigarette/day)
• Body weight variation \>10% during the last 6 months prior to the study baseline
• BMI \>35 kg/m2
• Previous history of cardiovascular disease, type 2 diabetes and monogenic dyslipidemia
• Subject taking anti-inflammatory drugs
• Subject with endocrine or gastrointestinal disorders
• Allergy, intolerance or aversion to dairy
• Clinical use of vitamin D or calcium supplements
• Vegetarians

Sponsors & Collaborators

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

Study Sites (1)

Institute of Nutraceuticals and Functional Foods (INAF)

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

• Drouin-Chartier JP, Gigleux I, Tremblay AJ, Poirier L, Lamarche B, Couture P. Impact of dairy consumption on essential hypertension: a clinical study. Nutr J. 2014 Aug 14;13:83. doi: 10.1186/1475-2891-13-83.

  PMID: 25123170 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Dairy Products; Milk; Cheese

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Patrick Couture, MD,FRCP,PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCP, PhD

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 28, 2013
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

CA (1)