Study protocol for a 15-week randomised controlled trial assessing the independent effects of high-cholesterol and high-saturated fat diets on LDL cholesterol

Participants will be male and female non-smokers, aged 18–60 years with a blood LDL-C concentration of less than 3.5 mmol/L. Detailed inclusion, exclusion and withdrawal criteria are listed in box 1.

Box 1

Eligibility criteria

Inclusion criteria

Males and females, aged 18–60 years.

Blood low-density lipoprotein cholesterol <3.5 mmol/L (measured at screening using an automated analyser; Cholestech LDX System).

Non-smoker (minimum 6 months).

Exclusion criteria

Cardiovascular disease.

Type 1 or type 2 diabetes.

Thyroid disorders.

Kidney or liver disease.

Gastrointestinal disorders requiring medical nutrition therapy (eg, Crohn’s disease, irritable bowel, coeliac disease).

Are pregnant or breast feeding.

Have allergies to eggs.

Consume more than 5 eggs per week in the month prior to beginning the trial.

Alcohol (>14 standard drinks/week) (1 standard drink=100 mL wine, 285 mL beer, 30 mL spirit) or drug dependency.

Have changed medication or supplementation that might affect study outcomes in the last 3 months.

Take vitamin, mineral, herbal supplementation or medications that may have an impact on study outcomes.

Are already involved in another research project within 30 days of commencement of the present study that in the opinion of the investigators will be unsuitable for this study.

Show unwillingness to follow any of the diets.

Failure to satisfy the investigator regarding suitability to participate for any other reason.

Are unwilling or unable to provide written consent.

Withdrawal criteria

Adverse reaction to diets.

The need to take a medication or treatment, which in the opinion of the investigator, may interfere with study measurements.

Weight loss or gain more than 5% of their baseline body weight.

Withdrawal of consent by the participant.

Failure to satisfy the investigator regarding suitability to participate for any other reason.

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