Hallelujah Acres Omega 3 Fat Study

Hallelujah Acres Omega 3 Fat Study

Sponsors

Lead Sponsor: Hallelujah Acres

Source 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.

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.

Overall Status Completed
Start Date 2012-01-01
Completion Date 2015-12-01
Primary Completion Date 2015-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Omega 3 Score 8 weeks of supplementation before testing
Enrollment 13
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Organic flax seed oil

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

Arm Group Label: Flax Oil and then Fish Oil

Other Name: Flora Flax Oil, organic.

Intervention Type: Dietary Supplement

Intervention Name: fish oil

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

Arm Group Label: Flax Oil and then Fish Oil

Other Name: Pharmax LLC Finest Pure Fish Oil

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michael Donaldson, PhD Principal Investigator Hallelujah Acres
Location
Facility: Hallelujah Acres Research Office / Laboratory
Location Countries

United States

Verification Date

2016-02-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Flax Oil and then Fish Oil

Type: Experimental

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

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: Single (Outcomes Assessor)

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