Hallelujah Acres Omega 3 Fat Study

Not Applicable

Completed

• Conditions: Omega 3 Fat Status
• Interventions: Dietary Supplement: Organic flax seed oil; Dietary Supplement: fish oil

• Registration Number: NCT01517685
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flax Oil and then Fish Oil	fish oil	All people in the study will use the flax seed oil and then the fish oil.
Flax Oil and then Fish Oil	Organic flax seed oil	All people in the study will use the flax seed oil and then the fish oil.

Primary Outcome Measures

Name	Time	Method
Omega 3 Score	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.

Trial Locations

Locations (1)

Hallelujah Acres Research Office / Laboratory; 🇺🇸 Zillah, Washington, United States