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

University of Reading

Status: Completed

Conditions: Hypercholesterolemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02089035

University of Reading (Other Identifier)

13/43

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

MUFA-rich dairy products

Experimental group

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.

Treatment:

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

Conventional dairy products

Experimental group

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.

Treatment:

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