Omega 3 Fat StatusNCT01517685
Hallelujah Acres Omega 3 Fat Study
A study testing Organic flax seed oil and fish oil in people with Omega 3 Fat Status, run by Hallelujah Acres at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Omega 3 Fat Status
- What is being tested?
- Organic flax seed oil and fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hallelujah Acres Research Office / Laboratory
Zillah, Washington, 98953
About this study
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.
Read the 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.
- Conditions
- Omega 3 Fat Status
- Being tested
- Organic flax seed oil, fish oil
- Keywords
- Eicosapentaenoic acid, EPA, Docosahexaenoic acid, DHA, Omega 3 fat, alpha-linoleic acid, ALA, fish oil, flax seed oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic flax seed oilDietary supplement
Also called Flora Flax Oil, organic.
2 tablespoons of organic flax seed oil are eaten daily for 8 weeks.
fish oilDietary supplement
Also called Pharmax LLC Finest Pure Fish Oil
5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Flax Oil and then Fish Oil | Experimental | All people in the study will use the flax seed oil and then the fish oil. Receives: Dietary Supplement: Organic flax seed oil; Dietary Supplement: fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks of supplementation before testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Omega 3 Fat StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallelujah Acres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Donaldson, PhD, Principal investigator, Hallelujah Acres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517685
- Sponsor's protocol ID
- 20111700
- Status last verified
- Feb 2016
- First submitted
- 23 Jan 2012
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hallelujah Acres Omega 3 Fat Study
- ClinicalTrials.gov ID
- NCT01517685
- Acronym / sponsor ID
- 20111700
- Conditions
- Omega 3 Fat Status
- Keywords
- Eicosapentaenoic acid, EPA, Docosahexaenoic acid, DHA, Omega 3 fat, alpha-linoleic acid, ALA, fish oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hallelujah AcresUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flax Oil and then Fish Oil | Experimental | Dietary Supplement: Organic flax seed oil, Dietary Supplement: fish oilAll people in the study will use the flax seed oil and then the fish oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organic flax seed oilAlso: Flora Flax Oil, organic.2 tablespoons of organic flax seed oil are eaten daily for 8 weeks. | Dietary supplement | Flax Oil and then Fish Oil |
| fish oilAlso: Pharmax LLC Finest Pure Fish Oil5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks. | Dietary supplement | Flax Oil and then Fish Oil |
Primary outcome
Omega 3 Score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Health and Nutritional Outcomes Among Young Females and Children in Southwest Bangladesh
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Donaldson, PhD principal investigator
Hallelujah Acres
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic flax seed oil and fish oil in people with Omega 3 Fat Status, run by Hallelujah Acres at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega 3 Score (time frame: 8 weeks of supplementation before testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.