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Dietary Phytosterols and Human Aortic Valve

NCT00738933 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-02-14

No results posted yet for this study

Summary

This randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. The study patients will include 50-60 voluntary patients from the Helsinki Univ. Central Hospital, who will undergo aortic valve surgery. The patients will be randomized into plant sterol (E), plant stanol (A) and control (C) groups. Patients in the E and A groups will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a margarine product.

Conditions

Interventions

DIETARY_SUPPLEMENT

Dietary plant stanols

Daily 2 grams of plant stanols in a margarine preparation for 4-8 weeks before the operation

DIETARY_SUPPLEMENT

Dietary plant sterols

Daily 2 grams of plant sterols in a margarine preparation for 4-8 weeks before the operation

DIETARY_SUPPLEMENT

placebo

Margarine product without plant stanol or sterol esters

Sponsors & Collaborators

  • University of Eastern Finland

    collaborator OTHER

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Tatu A. Miettinen, professor · Dept. of Medicine, Div. of Internal Medicine, Helsinki Univ. Central Hospital, Biomedicum Helsinki

  • Helena Gylling, Professor · Department of Clinical Nutrition, University of Kuopio and Kuopion University Central Hospital, Kuopio, Finland

  • Markku J Nissinen, MD, PhD · Dept. of Medicine, Div. of Gastroenterology, HUCH, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00738933 on ClinicalTrials.gov