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CompletedNCT01517685Updated Feb 19, 2016

Hallelujah Acres Omega 3 Fat Study

An interventional study of Organic flax seed oil and fish oil in Omega 3 Fat Status, sponsored by Hallelujah Acres. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-19.

Sponsored by Hallelujah Acres · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This research is being done to study the effect of taking flax seed oil and fish oil on blood lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our health and we want to see how effective both flax seed oil and fish oil are in raising your Omega 3 Score (higher is better). The Omega 3 Score is one of many indicators that may show your personal risk of dying suddenly from a heart attack.

Read the detailed description

This study is being conducted to compare the response of individuals to flax seed oil or fish oil, measured by blood lipids. Especially the amount of the long chain omega 3 polyunsaturated fats EPA and DHA will be tested. An omega 3 score for whole blood will be measured. The omega 3 score is the percent sum of omega 3 fats in the blood.

The hypothesis is that 5 grams of fish oil will increase the amount of EPA and DHA in a person's blood to a protective level, and that 30 grams (2 tablespoons) of flax oil will not change the blood levels of EPA significantly and not change the blood concentrations of DHA at all, even for a person consuming a low omega 6 oil diet and following a vegan diet high in fruits and vegetables.

Most of the testing of flax and fish oil has not been done in vegans. This trial will extend this testing to this subpopulation.

02

Conditions studied

  • Omega 3 Fat Status

Keywords

  • Eicosapentaenoic acid
  • EPA
  • Docosahexaenoic acid
  • DHA
  • Omega 3 fat
  • alpha-linoleic acid
  • ALA
  • fish oil
  • flax seed oil
03

In context

Lead sponsor

This is the only study on the registry with Hallelujah Acres as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have followed the Hallelujah Diet (or very similar diet) for at least the last two years,
  • Must have stable body weight (not gained or lost more than 5 pounds of weight over the last three months)

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (all pregnant women should take fish oil, not flax seed oil)
  • Currently using fish oil, or flax seed oil,EPA, DHA, or flax seed oil with added DHA
  • Eating more than 2 teaspoons of flax seed per day
  • Diabetes (fish oil may affect blood sugar levels)
  • Generally poor health
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Flax Oil and then Fish Oil

    All people in the study will use the flax seed oil and then the fish oil.

    Dietary Supplement: Organic flax seed oil · Dietary Supplement: fish oil

Interventions

  • Dietary supplementOrganic flax seed oil

    2 tablespoons of organic flax seed oil are eaten daily for 8 weeks.

    Also known as: Flora Flax Oil, organic.

  • Dietary supplementfish oil

    5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks.

    Also known as: Pharmax LLC Finest Pure Fish Oil

06

What researchers measure

Primary outcomes

  1. Omega 3 Score

    A finger prick blood sample is analyzed for fatty acids, including the amount of omega 3 fats in the blood. The Omega 3 Score is the amount of EPA and DHA in whole blood as a percent of fat.

    Time frame: 8 weeks of supplementation before testing

07

Study locations

1 site
  • Hallelujah Acres Research Office / Laboratory
    Zillah, Washington 98953, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01517685
Lead sponsor
Hallelujah Acres
Responsible party
Sponsor
First posted
Jan 25, 2012
Start date
Jan 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 19, 2016

Study contacts

Michael Donaldson, PhD
principal investigator · Hallelujah Acres

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fish Oils

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