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Hallelujah Acres Omega 3 Fat Study

This study is currently recruiting participants.
Verified January 2012 by Hallelujah Acres
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
History of Changes
  Purpose

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 Intervention
Omega 3 Fat Status
 Dietary Supplement: Organic flax seed oil
Dietary Supplement: fish oil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Hallelujah Acres Omega 3 Fat Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hallelujah Acres:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517685

Contacts
Contact: Michael Donaldson, PhD 704-406-6244 mdonaldson@hacres.com

Locations
United States, Washington
Hallelujah Acres Research Office / Laboratory Recruiting
Zillah, Washington, United States, 98953
Contact: Michael Donaldson, PhD     704-406-6244     mdonaldson@hacres.com    
Principal Investigator: Michael Donaldson, PhD            
Sponsors and Collaborators
Hallelujah Acres
Investigators
Principal Investigator: Michael Donaldson, PhD Hallelujah Acres
  More Information

No publications provided

Responsible Party: Hallelujah Acres
ClinicalTrials.gov Identifier: NCT01517685     History of Changes
Other Study ID Numbers: 20111700
Study First Received: January 23, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013