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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MUFA-rich dairy products (UHT milk, cheese and butter)
Conventional dairy products (UHT milk, cheese, butter)
Sponsored by
University of Reading
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Milk fatty acids, Total cholesterol, Vascular function, Blood pressure

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Food and Nutritional Sciences, University of Reading

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MUFA-rich dairy products

Conventional dairy products

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Chronic study: Changes in fasting plasma circulating levels of total cholesterol
Acute study: Changes in postprandial flow-mediated dilatation

Secondary Outcome Measures

Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)
Change in 24-hour ambulatory blood pressure
Changes in plasma circulating markers of vascular health
Changes in plasma circulating markers of inflammatory status
Changes in plasma circulating markers related to lipid metabolism
Changes in plasma circulating markers related to insulin resistance
Changes in vascular stiffness by Pulse Wave Velocity (PWV)
Changes in vascular stiffness by Pulse Wave Analysis (PWA)
Changes in vascular stiffness by Digital Volume Pulse (DVP)
Changes in monocytic cytokine production from whole blood culture
Changes in vascular reactivity by Flow Mediated Dilatation (FMD)
Changes in anthropometric measurements
Change in plasma phospholipid fatty acid composition

Full Information

First Posted
January 5, 2014
Last Updated
July 21, 2017
Sponsor
University of Reading
Collaborators
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT02089035
Brief Title
Replacement of Saturated Fat in Dairy on Total Cholesterol
Acronym
RESET
Official Title
Replacement of Saturated Fat in Dairy on Total Cholesterol, Vascular Function, Ambulatory Blood Pressure and Cardiovascular Risk Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Reading
Collaborators
Medical Research Council

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Milk fatty acids, Total cholesterol, Vascular function, Blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MUFA-rich dairy products
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional dairy products
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
MUFA-rich dairy products (UHT milk, cheese and butter)
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional dairy products (UHT milk, cheese, butter)
Primary Outcome Measure Information:
Title
Chronic study: Changes in fasting plasma circulating levels of total cholesterol
Time Frame
Chronic study: Baseline and week 12 for both intervention arms
Title
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 Measure Information:
Title
Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)
Time Frame
Chronic study: Baseline measurements (0min) for both intervention arms
Title
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)
Title
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
Title
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
Title
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
Title
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
Title
Changes in vascular stiffness by Pulse Wave Velocity (PWV)
Time Frame
Chronic study: Baseline (0 min) and week 12 for both intervention arms
Title
Changes in vascular stiffness by Pulse Wave Analysis (PWA)
Time Frame
Chronic study: Baseline (0 min) and week 12 for both intervention arms
Title
Changes in vascular stiffness by Digital Volume Pulse (DVP)
Time Frame
Chronic study: Baseline (0 min) and week 12 for both intervention arms
Title
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
Title
Changes in vascular reactivity by Flow Mediated Dilatation (FMD)
Time Frame
Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Title
Changes in anthropometric measurements
Time Frame
Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A. Lovegrove, BSc, PhD, RNutr
Organizational Affiliation
University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Food and Nutritional Sciences, University of Reading
City
Reading
State/Province
Berks
ZIP/Postal Code
RG6 6AP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22863409
Citation
Livingstone KM, Lovegrove JA, Givens DI. The impact of substituting SFA in dairy products with MUFA or PUFA on CVD risk: evidence from human intervention studies. Nutr Res Rev. 2012 Dec;25(2):193-206. doi: 10.1017/S095442241200011X. Epub 2012 Aug 6.
Results Reference
background
PubMed Identifier
20397059
Citation
Elwood PC, Pickering JE, Givens DI, Gallacher JE. The consumption of milk and dairy foods and the incidence of vascular disease and diabetes: an overview of the evidence. Lipids. 2010 Oct;45(10):925-39. doi: 10.1007/s11745-010-3412-5. Epub 2010 Apr 16.
Results Reference
background
PubMed Identifier
33758921
Citation
Markey O, Vasilopoulou D, Kliem KE, Fagan CC, Grandison AS, Sutton R, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Postprandial Fatty Acid Profile, but Not Cardiometabolic Risk Markers, Is Modulated by Dairy Fat Manipulation in Adults with Moderate Cardiovascular Disease Risk: The Randomized Controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) Study. J Nutr. 2021 Jul 1;151(7):1755-1768. doi: 10.1093/jn/nxab050.
Results Reference
derived
PubMed Identifier
32020168
Citation
Vasilopoulou D, Markey O, Kliem KE, Fagan CC, Grandison AS, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Reformulation initiative for partial replacement of saturated with unsaturated fats in dairy foods attenuates the increase in LDL cholesterol and improves flow-mediated dilatation compared with conventional dairy: the randomized, controlled REplacement of SaturatEd fat in dairy on Total cholesterol (RESET) study. Am J Clin Nutr. 2020 Apr 1;111(4):739-748. doi: 10.1093/ajcn/nqz344.
Results Reference
derived
PubMed Identifier
28535777
Citation
Markey O, Vasilopoulou D, Kliem KE, Koulman A, Fagan CC, Summerhill K, Wang LY, Grandison AS, Humphries DJ, Todd S, Jackson KG, Givens DI, Lovegrove JA. Plasma phospholipid fatty acid profile confirms compliance to a novel saturated fat-reduced, monounsaturated fat-enriched dairy product intervention in adults at moderate cardiovascular risk: a randomized controlled trial. Nutr J. 2017 May 23;16(1):33. doi: 10.1186/s12937-017-0249-2.
Results Reference
derived

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Replacement of Saturated Fat in Dairy on Total Cholesterol

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