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NCT Number: NCT02089035

Replacement of Saturated Fat in Dairy on Total Cholesterol

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MUFA-rich dairy products (UHT milk, cheese and butter)

Dietary Supplement

Conventional dairy products (UHT milk, cheese, butter)

Dietary Supplement

Primary outcomes

  1. Chronic study: Changes in fasting plasma circulating levels of total cholesterol

    Time frame: Chronic study: Baseline and week 12 for both intervention arms

  2. Acute study: Changes in postprandial flow-mediated dilatation

    Time frame: Acute study: 0, 180, 300 and 420 min at baseline and week 12 for both intervention arms

Secondary outcomes

  1. Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)

    Time frame: Chronic study: Baseline measurements (0min) for both intervention arms

  2. Change in 24-hour ambulatory blood pressure

    Time frame: 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)

  3. Changes in plasma circulating markers of vascular health

    Time frame: 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

  4. Changes in plasma circulating markers of inflammatory status

    Time frame: 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

  5. Changes in plasma circulating markers related to lipid metabolism

    Time frame: 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

  6. Changes in plasma circulating markers related to insulin resistance

    Time frame: 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

  7. Changes in vascular stiffness by Pulse Wave Velocity (PWV)

    Time frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms

  8. Changes in vascular stiffness by Pulse Wave Analysis (PWA)

    Time frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms

  9. Changes in vascular stiffness by Digital Volume Pulse (DVP)

    Time frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms

  10. Changes in monocytic cytokine production from whole blood culture

    Time frame: 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

  11. Changes in vascular reactivity by Flow Mediated Dilatation (FMD)

    Time frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.

  12. Changes in anthropometric measurements

    Time frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.

  13. Change in plasma phospholipid fatty acid composition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

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

Acronym: RESET

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2014
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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