Replacement of Saturated Fat in Dairy on Total Cholesterol (RESET)

July 21, 2017 updated by: Julie Lovegrove, University of Reading

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berks
      • Reading, Berks, United Kingdom, RG6 6AP
        • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MUFA-rich dairy products

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)
EXPERIMENTAL: Conventional dairy products

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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)
Time Frame: Chronic study: Baseline measurements (0min) for both intervention arms
Chronic study: Baseline measurements (0min) for both intervention arms
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)
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
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
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
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
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
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
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
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
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)
Time Frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in vascular stiffness by Pulse Wave Analysis (PWA)
Time Frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Chronic study: Baseline (0 min) and week 12 for both intervention arms
Changes in vascular stiffness by Digital Volume Pulse (DVP)
Time Frame: Chronic study: Baseline (0 min) and week 12 for both intervention arms
Chronic study: Baseline (0 min) and week 12 for both intervention arms
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
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)
Time Frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Changes in anthropometric measurements
Time Frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Medical Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

January 5, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (ESTIMATE)

March 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/43
  • University of Reading (Other Identifier: Reading University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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