Replacement of Saturated Fat in Dairy on Total Cholesterol

Study Overview
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Brief Summary
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The consumption of milk and dairy products is recognised as an essential part of a healthy diet as it represents an important source of key micro- and macronutrients. Nevertheless, there is still a widespread conviction that the overall high energy density and concentration of long-chain saturated fatty acids (SFA) present in dairy have detrimental health effects, contributing to the progression of cardiovascular disease, obesity and diabetes. Supplementation of the bovine diet with a source of MUFA, such as rapesee oil, has become an achievable strategy in order to reduce the amount of SFA present in dairy products. The aim of this project is to observe the effects of three types of dairy products (UHT milk, cheese and butter) produced from milk derived from cows fed withhigh-oleic sunflower oil, on CVD risk biomarkers and plasma total cholesterol levels in adults with an increased risk of developing CVD. The aim is to determine whether an isoenergetic exchange of dairy products will affect vascular function and CVD biomarkers.

Official Title
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Replacement of Saturated Fat in Dairy on Total Cholesterol, Vascular Function, Ambulatory Blood Pressure and Cardiovascular Risk Biomarkers

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: MUFA-rich dairy products (UHT milk, cheese and butter)
* Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mildly hypercholesterolemic: TC <5.2 and <8mmol/L Age: 25-70 BMI: 19-32 kg/m2 Haemoglobin: >125g/L for women and 135g/L for men Normal liver and kidney function Exclusion Criteria: Milk, cheese, butter, lactose allergy Drug treatment for hyperlipidaemia, hypertension, inflammation and hypercoagulation Suffered myocardial infarction/stroke in the past 12months Diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders Surgery in the previous 6 months Excessive alcohol consumption (>28 unit/wk man; >21 unit/wk women) Taking vitamin, mineral or fatty acid supplements (e.g. fish oil, calcium) Pregnant, lactating, planning a pregnancy or not using effective contraceptive precautions Smokers Vegans Anaemic Planning or on a weight reduction scheme Parallel participation in another intervention study Participating in intensive aerobic activity for > 20 minutes 3 times per week Use of anti-inflammatory medication

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MUFA-rich dairy products<br>Subjects are asked to exchange habitual dairy products for modified MUFA-rich experimental dairy products for a 12 week period. Participants will provided with standardised quantities of pasteurised UHT milk, cheese and butter that they will be asked to consume on a daily basis. | Dietary Supplement: MUFA-rich dairy products (UHT milk, cheese and butter)<br> <br> |
| Experimental: Conventional dairy products<br>Subjects are asked to consume habitual non-modified dairy products for a period of 12 weeks. Participants will provided with standardised quantities of pasteurised UHT milk, cheese and butter that they will be asked to consume on a daily basis. | Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic study: Changes in fasting plasma circulating levels of total cholesterol |  | Chronic study: Baseline and week 12 for both intervention arms | 
| Acute study: Changes in postprandial flow-mediated dilatation |  | Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT) |  | Chronic study: Baseline measurements (0min) for both intervention arms | 
| Change in 24-hour ambulatory blood pressure |  | Chronic study: baseline (-1week) and week 11, 19 and 31 for 24 hours. Measurements will be recorded every 30min (7am to 10pm) and every hour (10pm-7am) | 
| Changes in plasma circulating markers of vascular health |  | Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms | 
| Changes in plasma circulating markers of inflammatory status |  | Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms | 
| Changes in plasma circulating markers related to lipid metabolism |  | Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms | 
| Changes in plasma circulating markers related to insulin resistance |  | Chronic study: Baseline and week 12 for both intervention arms. Acute study: area under the curve from 0-8 h after consumption of breakfast (0 min) and lunch (330 min) for both intervention arms | 
| Changes in vascular stiffness by Pulse Wave Velocity (PWV) |  | Chronic study: Baseline (0 min) and week 12 for both intervention arms | 
| Changes in vascular stiffness by Pulse Wave Analysis (PWA) |  | Chronic study: Baseline (0 min) and week 12 for both intervention arms | 
| Changes in vascular stiffness by Digital Volume Pulse (DVP) |  | Chronic study: Baseline (0 min) and week 12 for both intervention arms | 
| Changes in monocytic cytokine production from whole blood culture |  | Chronic and acute study: Baseline and week 12 for both intervention arms. Acute: area under the curve from 0-8 h following consumption of breakfast (0 min) and lunch (330 min) for both intervention arms | 
| Changes in vascular reactivity by Flow Mediated Dilatation (FMD) |  | Chronic study: Baseline and assessment at 12 weeks for each intervention arm. | 
| Changes in anthropometric measurements |  | Chronic study: Baseline and assessment at 12 weeks for each intervention arm. | 
| Change in plasma phospholipid fatty acid composition |  | Chronic and acute study: Baseline and week 12 for both intervention arms. Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Milk fatty acids, Total cholesterol, Vascular function, Blood pressure