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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313988
• Other study ID #: 10018V
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: February 5, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy
• Hypercholesterolemia
• Mildly Elevated Cholesterol Levels

Intervention

Dietary Supplement:
• Plant sterols and fish oil
4 weeks intervention, 3 times daily
• Plant sterols
4 weeks intervention, 3 times daily
• Placebo
4 weeks, 3 times daily

Locations

Country	Name	City	State
Sweden	KPL Good Food Practice AB	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood lipid profile	Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides	At baseline (after 4 weeks run-in period) and after 4 weeks intervention	No
Secondary	Change in EPA/DHA in red blood cells		At baseline (after 4 weeks run-in period) and after 4 weeks intervention	No
Secondary	Change in metabolomic parameters	For exploratory purposes	At baseline (after 4 weeks run-in period) and after 4 weeks intervention	No