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The effects of plant stanol esters on intestinal mucosal gene expression profiles and microbiota composition in healthy human subjects.

The effects of plant stanol esters on intestinal mucosal gene expression profiles and microbiota composition in healthy human subjects. - Plant stanols and gene expression profile

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37742
Enrollment
20
Registered
2012-03-14
Start date
2012-03-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Hypercholesterolemia

Interventions

During each test period, the volunteers will use a plant sterol/stanol poor diet for 1 week followed by the consumption of the investigational products (margarines with or without added plant stanol

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: aged between 18 and 60 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 - 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 - gastrointestinal diseases - not willing to stop the consumption of probiotica and antibiotica during the study

Design outcomes

Primary

MeasureTime frame
Analysis of the intestinal mucosal gene expression profiles.

Secondary

MeasureTime frame
Analysis of changes in microbiota composition. Serum/plasma concentrations of plant sterols/stanols, lipids, lipoproteins, free fatty acids, glucose, insuline and markers of endothelial dysfunction. Analysis of the expression of nutrient sensing receptors (T1R2, T1R3,...)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)