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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

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.


Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: MUFA-rich dairy products (UHT milk, cheese and butter) Dietary Supplement: Conventional dairy products (UHT milk, cheese, butter) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Replacement of Saturated Fat in Dairy on Total Cholesterol, Vascular Function, Ambulatory Blood Pressure and Cardiovascular Risk Biomarkers
Study Start Date : May 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089035


Locations
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United Kingdom
Department of Food and Nutritional Sciences, University of Reading
Reading, Berks, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Medical Research Council
Investigators
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Principal Investigator: Julie A. Lovegrove, BSc, PhD, RNutr University of Reading
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT02089035    
Other Study ID Numbers: 13/43
University of Reading ( Other Identifier: University of Reading )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: May 2016
Keywords provided by Julie Lovegrove, University of Reading:
Milk fatty acids
Total cholesterol
Vascular function
Blood pressure
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases