Hallelujah Acres Omega 3 Fat Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hallelujah Acres.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hallelujah Acres
ClinicalTrials.gov Identifier:
NCT01517685
First received: January 23, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 23, 2012
January 24, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
Omega 3 Score [ Time Frame: 8 weeks of supplementation before testing ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01517685 on ClinicalTrials.gov Archive Site
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Hallelujah Acres Omega 3 Fat Study
Hallelujah Acres Omega 3 Fat Study

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Omega 3 Fat Status
  • 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
Experimental: Flax Oil and then Fish Oil
All people in the study will use the flax seed oil and then the fish oil.
Interventions:
  • Dietary Supplement: Organic flax seed oil
  • Dietary Supplement: fish oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Michael Donaldson, PhD 704-406-6244 mdonaldson@hacres.com
United States
 
NCT01517685
20111700
No
Hallelujah Acres
Hallelujah Acres
Not Provided
Principal Investigator: Michael Donaldson, PhD Hallelujah Acres
Hallelujah Acres
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP