Hallelujah Acres Omega 3 Fat Study

NCT ID: NCT01517685

Last Updated: 2016-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Omega 3 Fat Status

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Flax Oil and then Fish Oil

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

Group Type EXPERIMENTAL

Organic flax seed oil

Intervention Type DIETARY_SUPPLEMENT

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

fish oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Organic flax seed oil

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

Intervention Type DIETARY_SUPPLEMENT

fish oil

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Flora Flax Oil, organic. Pharmax LLC Finest Pure Fish Oil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hallelujah Acres

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Donaldson, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallelujah Acres

Locations

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Hallelujah Acres Research Office / Laboratory

Zillah, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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20111700

Identifier Type: -

Identifier Source: org_study_id

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