Effects of buttermilk with or without lutein-enriched egg yolk on the serum LDL-cholesterol concentration of slightly hypercholesterolemic volunteers

Recruiting

• Conditions: cholesterol metabolisme; hypercholesterolemia

• Registration Number: NL-OMON38303
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Subjects are asked to fill out a general health questionnaire in between the first and second screening visit. Only healthy subjects will be included. Obviously, the remark healthy only concerns the aspects checked for in the in and exclusion criteria. The inclusion criteria are:
• aged between 18 and 70 years
• fasting serum total cholesterol between 5.5 - 8.0 mmol/L
• fasting plasma glucose <7.0 mmol/L
• BMI between 25 - 30 kg/m2
• non-smoking
• willingness to abstain for the duration of the study from egg consumption

Exclusion Criteria

• unstable body weight (weight gain or loss >3 kg in the past 3 months)
• allergic for eggs or egg-rich products
• allergic or intolerant for cow-milk (lactose) based products
• indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
• use of medication or a diet known to affect serum lipid or glucose metabolism
• active cardiovascular disease (for instance congestive heart failure) or recent (<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
• not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
• men: consumption of >21 alcohol consumptions a week
• women: consumption of >14 alcohol consumptions a week
• abuse of drugs
• pregnant or breastfeeding women
• participation in another biomedical study within 1 month prior to the screening visit
• having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
• impossible or difficult venipuncture as evidenced during the screening visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Measurements will be performed during the run-in period (days 0, 11 and 14) and<br /><br>during the experimental period (days 56, 95 and 98). The main effects (egg-yolk<br /><br>and buttermilk consumption) will be calculated as the absolute differences<br /><br>between values obtained at the end of the experimental (average days 95 and 98)<br /><br>and run-in (average days 11 and 14) periods. The primary endpoint is the change<br /><br>in serum LDL-cholesterol concentrations. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are changes in serum total and HDL cholesterol,<br /><br>triacylglycerol, apoA-I, apoB and hsCRP concentrations.<br /><br><br /><br>In addition, we would like to determine, via DNA analysis, polymorphisms in<br /><br>genes that play a role in (LDL) cholesterol metabolism, such as genes coding<br /><br>for the LDL receptor, PCSK9, SRBI, HMG-CoA reductase, ApoB and ApoE. </p><br>