Replacement of Saturated Fat in Dairy on Total Cholesterol

Hypercholesterolemia Clinical Trial

— RESET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089035
• Other study ID #: 13/43
• Secondary ID: University of Re
• Status: Completed
• Phase: N/A
• First received: January 5, 2014
• Last updated: July 21, 2017
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• MUFA-rich dairy products (UHT milk, cheese and butter)

• Conventional dairy products (UHT milk, cheese, butter)

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berks

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic study: Changes in fasting plasma circulating levels of total cholesterol		Chronic study: Baseline and week 12 for both intervention arms
Primary	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	Changes in vascular stiffness by Carotid Intima Media Thickness (CIMT)		Chronic study: Baseline measurements (0min) for both intervention arms
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in plasma circulating markers related to insulin resistance		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
Secondary	Changes in vascular stiffness by Pulse Wave Velocity (PWV)		Chronic study: Baseline (0 min) and week 12 for both intervention arms
Secondary	Changes in vascular stiffness by Pulse Wave Analysis (PWA)		Chronic study: Baseline (0 min) and week 12 for both intervention arms
Secondary	Changes in vascular stiffness by Digital Volume Pulse (DVP)		Chronic study: Baseline (0 min) and week 12 for both intervention arms
Secondary	Changes in monocytic cytokine production from whole blood culture		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
Secondary	Changes in vascular reactivity by Flow Mediated Dilatation (FMD)		Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Secondary	Changes in anthropometric measurements		Chronic study: Baseline and assessment at 12 weeks for each intervention arm.
Secondary	Change in plasma phospholipid fatty acid composition		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