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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01313988
First received: March 2, 2011
Last updated: February 5, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Healthy
Mildly Elevated Cholesterol Levels
Dietary Supplement: Plant sterols and fish oil
Dietary Supplement: Plant sterols
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Change in blood lipid profile [ Time Frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention ] [ Designated as safety issue: No ]
    Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides


Secondary Outcome Measures:
  • Change in EPA/DHA in red blood cells [ Time Frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention ] [ Designated as safety issue: No ]
  • Change in metabolomic parameters [ Time Frame: At baseline (after 4 weeks run-in period) and after 4 weeks intervention ] [ Designated as safety issue: No ]
    For exploratory purposes


Enrollment: 332
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose 1
Spread that contains plant sterols and fish oil
Dietary Supplement: Plant sterols and fish oil
4 weeks intervention, 3 times daily
Active Comparator: Dose 2
Spread that contains plant sterols and fish oil
Dietary Supplement: Plant sterols and fish oil
4 weeks intervention, 3 times daily
Active Comparator: Dose 3
Spread that contains plant sterols and fish oil
Dietary Supplement: Plant sterols and fish oil
4 weeks intervention, 3 times daily
Placebo Comparator: Placebo
Placebo spread
Dietary Supplement: Placebo
4 weeks, 3 times daily
Active Comparator: Control
Spread that contains plant sterols
Dietary Supplement: Plant sterols
4 weeks intervention, 3 times daily

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313988

Locations
Sweden
KPL Good Food Practice AB
Uppsala, Sweden, S-751 83
Sponsors and Collaborators
Unilever R&D
Investigators
Principal Investigator: Johan Olsson, PhD KPL Good Food Practice AB
Study Director: Birgitta Sundberg, PhD KPL Good Food Practice AB
Study Director: Anneli Hallmin KPL Good Food Practice AB
  More Information

No publications provided

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01313988     History of Changes
Other Study ID Numbers: 10018V
Study First Received: March 2, 2011
Last Updated: February 5, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Unilever R&D:
dose-response study
blood lipid profile
plant sterols
fish oil

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 22, 2014