NCT01517685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

January 23, 2012

Last Update Submit

February 17, 2016

Conditions

Omega 3 Fat Status

Keywords

Eicosapentaenoic acidEPADocosahexaenoic acidDHAOmega 3 fatalpha-linoleic acidALAfish oilflax seed oil

Outcome Measures

Primary Outcomes (1)

  • Omega 3 Score

    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.

    8 weeks of supplementation before testing

Study Arms (1)

Flax Oil and then Fish Oil

EXPERIMENTAL

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

Dietary Supplement: Organic flax seed oilDietary Supplement: fish oil

Interventions

Organic flax seed oilDIETARY_SUPPLEMENT

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

Also known as: Flora Flax Oil, organic.
Flax Oil and then Fish Oil
fish oilDIETARY_SUPPLEMENT

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

Also known as: Pharmax LLC Finest Pure Fish Oil
Flax Oil and then Fish Oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallelujah Acres Research Office / Laboratory

Zillah, Washington, 98953, United States

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Michael Donaldson, PhD

    Hallelujah Acres

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

US(1)