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

Tracking Information

First Received Date ^ICMJE

January 23, 2012

Last Updated Date

January 24, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01517685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hallelujah Acres Omega 3 Fat Study

Official Title ^ICMJE

Hallelujah Acres Omega 3 Fat Study

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Omega 3 Fat Status

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Michael Donaldson, PhD

704-406-6244

mdonaldson@hacres.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01517685

Other Study ID Numbers ^ICMJE

20111700

Has Data Monitoring Committee

Responsible Party

Hallelujah Acres

Study Sponsor ^ICMJE

Hallelujah Acres

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Donaldson, PhD

Hallelujah Acres

Information Provided By

Hallelujah Acres

Verification Date

January 2012

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

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