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Hallelujah Acres Omega 3 Fat Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517685
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Hallelujah Acres

Brief 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.

Condition or disease Intervention/treatment Phase
Omega 3 Fat Status Dietary Supplement: Organic flax seed oil Dietary Supplement: fish oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Hallelujah Acres Omega 3 Fat Study
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
2 tablespoons of organic flax seed oil are eaten daily for 8 weeks.
Other Name: Flora Flax Oil, organic.

Dietary Supplement: fish oil
5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks.
Other Name: Pharmax LLC Finest Pure Fish Oil

Primary Outcome Measures :
  1. Omega 3 Score [ Time Frame: 8 weeks of supplementation before testing ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517685

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United States, Washington
Hallelujah Acres Research Office / Laboratory
Zillah, Washington, United States, 98953
Sponsors and Collaborators
Hallelujah Acres
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Principal Investigator: Michael Donaldson, PhD Hallelujah Acres

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Responsible Party: Hallelujah Acres Identifier: NCT01517685     History of Changes
Other Study ID Numbers: 20111700
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Hallelujah Acres:
Eicosapentaenoic acid
Docosahexaenoic acid
Omega 3 fat
alpha-linoleic acid
fish oil
flax seed oil