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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Unilever R&D

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014