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

Primary Purpose

Healthy, Mildly Elevated Cholesterol Levels

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Plant sterols and fish oil
Plant sterols
Placebo
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring dose-response study, blood lipid profile, plant sterols, fish oil

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KPL Good Food Practice AB

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Dose 1

Dose 2

Dose 3

Placebo

Control

Arm Description

Spread that contains plant sterols and fish oil

Spread that contains plant sterols and fish oil

Spread that contains plant sterols and fish oil

Placebo spread

Spread that contains plant sterols

Outcomes

Primary Outcome Measures

Change in blood lipid profile
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides

Secondary Outcome Measures

Change in EPA/DHA in red blood cells
Change in metabolomic parameters
For exploratory purposes

Full Information

First Posted
March 2, 2011
Last Updated
February 5, 2012
Sponsor
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01313988
Brief Title
Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mildly Elevated Cholesterol Levels
Keywords
dose-response study, blood lipid profile, plant sterols, fish oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Active Comparator
Arm Description
Spread that contains plant sterols and fish oil
Arm Title
Dose 2
Arm Type
Active Comparator
Arm Description
Spread that contains plant sterols and fish oil
Arm Title
Dose 3
Arm Type
Active Comparator
Arm Description
Spread that contains plant sterols and fish oil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo spread
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Spread that contains plant sterols
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant sterols and fish oil
Intervention Description
4 weeks intervention, 3 times daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant sterols
Intervention Description
4 weeks intervention, 3 times daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
4 weeks, 3 times daily
Primary Outcome Measure Information:
Title
Change in blood lipid profile
Description
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
Time Frame
At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Secondary Outcome Measure Information:
Title
Change in EPA/DHA in red blood cells
Time Frame
At baseline (after 4 weeks run-in period) and after 4 weeks intervention
Title
Change in metabolomic parameters
Description
For exploratory purposes
Time Frame
At baseline (after 4 weeks run-in period) and after 4 weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Olsson, PhD
Organizational Affiliation
KPL Good Food Practice AB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgitta Sundberg, PhD
Organizational Affiliation
KPL Good Food Practice AB
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anneli Hallmin
Organizational Affiliation
KPL Good Food Practice AB
Official's Role
Study Director
Facility Information:
Facility Name
KPL Good Food Practice AB
City
Uppsala
ZIP/Postal Code
S-751 83
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25122648
Citation
Ras RT, Demonty I, Zebregs YE, Quadt JF, Olsson J, Trautwein EA. Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women. J Nutr. 2014 Oct;144(10):1564-70. doi: 10.3945/jn.114.192229. Epub 2014 Aug 13.
Results Reference
derived

Learn more about this trial

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

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