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

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ClinicalTrials.gov Identifier: NCT02089035
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

Tracking Information
First Submitted Date  ICMJE January 5, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date July 24, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Chronic study: Changes in fasting plasma circulating levels of total cholesterol [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Changes in vascular reactivity by Flow Mediated Dilatation (FMD) [ Time Frame: Chronic study: Baseline and assessment at 12 weeks for each intervention arm. Acute study: determined at baseline (0min), 180min, 300min and 420min ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT) [ Time Frame: 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) ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Changes in vascular stiffness by Pulse Wave Velocity (PWV) [ Time Frame: 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 ]
  • Changes in vascular stiffness by Digital Volume Pulse (DVP) [ Time Frame: 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 ]
  • Changes in vascular reactivity by Flow Mediated Dilatation (FMD) [ Time Frame: 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. ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT) [ Time Frame: 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) ]
  • Changes in plasma circulating markers of vascular health [ Time Frame: Chronic study: Baseline and week 12 for both intervention arms. Acute study: baseline (0 min) and endpoint (420 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: baseline (0 min) and endpoint (420 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: baseline (0 min) and endpoint (420 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: baseline (0 min) and enpoint (420 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 ]
  • Changes in vascular stiffness by Pulse Wave Analysis (PWA) [ Time Frame: 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 ]
  • Changes in monocytic cytokine production from whole blood culture [ Time Frame: Chronic and acute study: Baseline and week 12 for both intervention arms at 4 specific timepoints during acute study (-30 min, 180min, 300min and 420min) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Replacement of Saturated Fat in Dairy on Total Cholesterol
Official Title  ICMJE Replacement of Saturated Fat in Dairy on Total Cholesterol, Vascular Function, Ambulatory Blood Pressure and Cardiovascular Risk Biomarkers
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: MUFA-rich dairy products (UHT milk, cheese and butter)
  • Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter)
Study Arms  ICMJE
  • 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.

    Intervention: 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.

    Intervention: Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
60
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089035
Other Study ID Numbers  ICMJE 13/43
University of Reading ( Other Identifier: University of Reading )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Lovegrove, University of Reading
Study Sponsor  ICMJE University of Reading
Collaborators  ICMJE Medical Research Council
Investigators  ICMJE
Principal Investigator: Julie A. Lovegrove, BSc, PhD, RNutr University of Reading
PRS Account University of Reading
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP