NCT01788917

Brief Summary

The study was performed to investigate the effects of a daily consumption of linseed oil on fatty acid distribution in plasma and red blood cell lipids and blood lipids in vegetarians.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

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

September 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
Last Updated

October 10, 2022

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

February 6, 2013

Last Update Submit

October 5, 2022

Conditions

Inter-conversion n-3 PUFA, Vegetarians

Keywords

n-3 LC-PUFA, vegetarians, fatty acids, blood lipids

Outcome Measures

Primary Outcomes (1)

  • EPA concentrations in plasma lipids and red blood cell lipids

    10 weeks

Secondary Outcomes (1)

  • blood lipids

    10 weeks

Other Outcomes (1)

  • parameters of iron status

    10 weeks

Study Arms (2)

Vegetarians

EXPERIMENTAL

Dietary supplement: 10 mL linseed oil per day

Dietary Supplement: Linseed oil

Omnivores

PLACEBO COMPARATOR

Dietary supplement: 10 mL linseed oil per day

Dietary Supplement: Linseed oil

Interventions

Linseed oilDIETARY_SUPPLEMENT

Dietary supplement: 10 mL linseed oil per day

OmnivoresVegetarians

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • for the vegetarian sub-group : vegetarian diet pattern

You may not qualify if:

  • high performance sport, daily alcohol intake and the in-take of dietary supplements (e.g., fish oil capsules)
  • for the vegetarian sub-group, the consumption of fish and algae products (e.g. seaweeds, sushi)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. G. Jahreis

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 11, 2013

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

October 10, 2022

Record last verified: 2013-02