NCT02089035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 24, 2017

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

January 5, 2014

Last Update Submit

July 21, 2017

Conditions

Hypercholesterolemia

Keywords

Milk fatty acidsTotal cholesterolVascular functionBlood pressure

Outcome Measures

Primary Outcomes (2)

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

    Chronic study: Baseline and week 12 for both intervention arms

  • Acute study: Changes in postprandial flow-mediated dilatation

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

Secondary Outcomes (13)

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

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

  • Change in 24-hour ambulatory blood pressure

    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

    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

    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

    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

  • +8 more secondary outcomes

Study Arms (2)

MUFA-rich dairy products

EXPERIMENTAL

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)

Conventional dairy products

EXPERIMENTAL

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)

Interventions

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

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, RG6 6AP, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 22863409BACKGROUND

  • 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.

    PMID: 20397059BACKGROUND

  • 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.

    PMID: 33758921DERIVED

  • 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.

    PMID: 32020168DERIVED

  • 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.

    PMID: 28535777DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

CheeseButter

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and BeveragesDietary FatsFatsLipids

Study Officials

  • Julie A. Lovegrove, BSc, PhD, RNutr

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2014

First Posted

March 17, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 24, 2017

Record last verified: 2016-05

Locations

GB(1)