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The effects of plant sterol and stanol esters on serum oxyphytosterol concentrations in healthy human subjects

The effects of plant sterol and stanol esters on serum oxyphytosterol concentrations in healthy human subjects - Phytosterols and oxyphytosterol concentrations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36657
Enrollment
48
Registered
2010-02-24
Start date
2010-03-01
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

increased phytosterol concentrations

Interventions

During each test period, the volunteers will consume 20 gram of a plant sterol-enriched margarine (providing daily 3.0 gram of plant sterols), a plant stanol-enriched margarine (providing daily 3.0

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: aged between 18 and 70 years Body Mass Index (BMI) between 20-30 kg/m2 mean serum total cholesterol

Exclusion criteria

Exclusion criteria: - unstable body weight (weight gain or loss > 3 kg in the past two months) - active cardiovascular diseases like congestive heart failure or recent (21 units per week) - not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in sterol or stanol esters 4 weeks before the start of the study (wash-in period) - use of an investigational product within another biomedical study within the previous month - pregnant or breast-feeding women - not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study - current smoker - anemia. with a Hb-level below 7.5 mmol/L for men and below 7.0 mmol/L for women, as indicated by the blood bank of Maastricht

Design outcomes

Primary

MeasureTime frame
serum / plasma concentrations of plant sterols and oxyphytosterols,

Secondary

MeasureTime frame
Concentrations of lipoproteins, glucose, insulin, and markers reflecting low-grade systemic inflammation and endothelial dysfunction.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)