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Validation of plasma plant sterol levels as markers of cholesterol absorption

Validation of plasma plant sterol levels as markers of cholesterol absorption - DAHLIA-2A

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33370
Enrollment
68
Registered
2009-11-20
Start date
2009-10-01
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

mild hypercholesterolemia slightly elevated cholesterol

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female subjects, aged 18-65 years old, with an LDL-cholesterol concentration between 3.0 and 5.0 mmol/l, who participated in the Dahlia-1 study and belong to the 40 subjects with the highest or to the 40 subjects with the lowest plasma campesterol/TC ratios respectively.

Exclusion criteria

Exclusion criteria: Excluded are persons with a genetic hyperlipoproteinemia like familial hypercholesterolemia, LPL-deficiency, familial dysbeta lipoproteinemia and familial hypertriglyceridemia. Also people with diabetes mellitus, severe hypertriglyceridemia, uncontrolled hypertension or history of arterial disease including unstable angina, myocardial infarction, recent transient ischaemic attacks or a cerebro-vascular accident, will be excluded.

Design outcomes

Secondary

MeasureTime frame
Correlation of cholesterol absorption as measured by the dual isotope method with cholesterol absorption as measured by the continuous feeding method.

Primary

MeasureTime frame
1. The difference in fractional cholesterol absorption, determined by the dual isotope method, between 40 subjects with high and 40 subjects with low baseline campesterol/TC ratios (combined results of Dahlia-2 and Dahlia-2a study). 2. Correlation of plasma campesterol/TC ratios with cholesterol absorption, determined by the dual isotope method in 80 subjects with mild hypercholesterolemia (combined results of Dahlia-2 and Dahlia-2a study).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)