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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38303
Enrollment
120
Registered
2010-10-08
Start date
2011-01-02
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholesterol metabolisme hypercholesterolemia

Interventions

During the entire study period, volunteers are instructed to consume a diet according to the Dutch dietary guidelines (35 en% fat (10en% saturated fat), 50-55 en% carbohydrates). During the two week

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 (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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)