NCT01313988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 7, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

March 2, 2011

Last Update Submit

February 5, 2012

Conditions

HealthyMildly Elevated Cholesterol Levels

Keywords

dose-response studyblood lipid profileplant sterolsfish oil

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in EPA/DHA in red blood cells

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

  • Change in metabolomic parameters

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

Study Arms (5)

Dose 1

ACTIVE COMPARATOR

Spread that contains plant sterols and fish oil

Dietary Supplement: Plant sterols and fish oil

Dose 2

ACTIVE COMPARATOR

Spread that contains plant sterols and fish oil

Dietary Supplement: Plant sterols and fish oil

Dose 3

ACTIVE COMPARATOR

Spread that contains plant sterols and fish oil

Dietary Supplement: Plant sterols and fish oil

Placebo

PLACEBO COMPARATOR

Placebo spread

Dietary Supplement: Placebo

Control

ACTIVE COMPARATOR

Spread that contains plant sterols

Dietary Supplement: Plant sterols

Interventions

Plant sterols and fish oilDIETARY_SUPPLEMENT

4 weeks intervention, 3 times daily

Dose 1Dose 2Dose 3
Plant sterolsDIETARY_SUPPLEMENT

4 weeks intervention, 3 times daily

Control
PlaceboDIETARY_SUPPLEMENT

4 weeks, 3 times daily

Placebo

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KPL Good Food Practice AB

Uppsala, S-751 83, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 25122648DERIVED

MeSH Terms

Interventions

PhytosterolsFish Oils

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological FactorsOils

Study Officials

  • Johan Olsson, PhD

    KPL Good Food Practice AB

    PRINCIPAL INVESTIGATOR

  • Birgitta Sundberg, PhD

    KPL Good Food Practice AB

    STUDY DIRECTOR

  • Anneli Hallmin

    KPL Good Food Practice AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 14, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 7, 2012

Record last verified: 2012-01

Locations

SE(1)