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NCT Number: NCT01313988

Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil

Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.

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Key information

Conditions

Healthy Mildly Elevated Cholesterol Levels

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KPL Good Food Practice AB

Uppsala, S-751 83, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Apparently healthy men and women
  • Age ≥ 25 and ≤ 75 years old
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
  • Total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/L
  • 10-year CVD risk equal or lower than 10% according to "SCORE"
  • Blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges
  • Informed consent and biobank consent signed
  • Willing to comply to study protocol during study
  • Agreeing to be informed about medically relevant personal test-results by a physician
  • Not smoking
  • Accessible veins on the forearm
  • Habitually consuming spreads

Exclusion criteria

  • Pregnant or having the wish to become pregnant, or lactating
  • Use of prescribed medication which may interfere with study measurements
  • Use of antibiotics in the 3 months before screening or during the study
  • Use of any medically- or self-prescribed diet with the purpose to reduce weight
  • Intolerance for gluten or lactose
  • Reported food allergy
  • Having bleeding disorders
  • Recent blood donation
  • Excessive alcohol consumption
  • Strenuous exercise
  • Reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs
  • Recent participation in another nutritional or medical trial
  • Participation in night shift work

Treatment and study plan

Plant sterols and fish oil

Dietary Supplement

4 weeks intervention, 3 times daily

Plant Sterols

Dietary Supplement

4 weeks intervention, 3 times daily

Placebo

Dietary Supplement

4 weeks, 3 times daily

Primary outcomes

  1. Change in blood lipid profile

    Time frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention

    Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides

Secondary outcomes

  1. Change in EPA/DHA in red blood cells

    Time frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention

  2. Change in metabolomic parameters

    Time frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention

    For exploratory purposes

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

Efficacy Study on the Lipid-lowering Effect of a Spread Enriched With the Recommended Dose of Plant Sterols and 3 Different Doses of Fatty Acids From Fish Oil

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2011
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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