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Healthy VolunteersNCT01369550

Efficacy Study of Stearidonic Acid (SDA) Soybean Oil-containing Foods on Red Blood Cell Fatty Acid Content

A study testing SDA soybean oil-containing foods, High-oleic sunflower oil containing foods and Eicosapentaenoic acid in people with Healthy Volunteers and Markers of Cardiovascular Risk, run by Monsanto Company, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical trial is to evaluate whether the omega-3 fatty acid stearidonic acid (SDA), when used as a food ingredient, increases the level of the long-chain omega-3 fatty acid eicosapentaenoic acid (EPA) in red blood cell (RBC) membranes in men and women. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
What is being tested?
SDA soybean oil-containing foods, High-oleic sunflower oil containing foods and Eicosapentaenoic acid
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
2 sitesUnited States
Study dates
Aug 2010to Jan 2011
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject is male or female, 21 to 65 years of age, inclusive.
  • Body mass index (BMI) ≥18.00 and <40.00 kg/m2 at visit 1, week -2.
  • Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
  • Subject is willing to avoid alcohol consumption for 24 h prior to every clinic visit.
  • Subject has no plans to change smoking habits during the study period.
  • Subject is willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed.
  • Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Who cannot join

  • Subject has coronary heart disease or a coronary heart disease risk equivalent including any of the following:
  • Diabetes mellitus (or fasting glucose ≥126 mg/dL at visit 1, week -2);
  • Clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease [symptomatic (e.g., transient ischemic attack or stroke of carotid origin) or >50% stenosis on angiography or ultrasound] or other forms of clinical atherosclerotic disease (e.g., renal artery disease);
  • Presence of multiple risk factors that give a person a greater than 20% chance for developing coronary artery disease within 10 years. This will be determined by the Framingham risk index calculated at visit 1, week -2.
  • Abnormal laboratory test results of clinical significance, including, but not limited to creatinine ≥1.5 mg/dL and ALT or AST ≥1.5X the upper limit of normal at visit 1, week -2.
  • TG ≥400 mg/dL at visit 1, week -2.
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  • Subject smokes more than one pack of cigarettes (20 cigarettes) per day.
  • Subject has a history or presence of clinically important renal, hepatic, pulmonary, biliary, gastrointestinal, neurologic or endocrine disorders that in the judgment of the Investigator, would interfere with the subject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the subject at undue risk. Stable, treated hypothyroidism is allowed.
  • Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure measured at visit 1, week -2). One re-test will be allowed on a separate day prior to visit 2, week 0 for subjects whose blood pressure exceeds either of these cut points at visit 1, week -2.
  • Unstable use (initiation or change in dose) within four weeks of visit 1 (week -2; Appendix 1) of antihypertensive medications or thyroid hormone replacement.
  • Use of any lipid-altering drugs, including statins, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, or prescription formulations of niacin within four weeks of visit 1 (week -2) and throughout the study. If a subject needs to wash off of a drug, he/she will be consented and then asked to return after the four week washout.
  • Use of EPA/DHA from a drug or supplement within four months of visit 1, week -2 and throughout the study period. If subject has used >1.0 g/d of EPA, DHA, or combination of EPA and DHA from a drug or supplement, use must have been discontinued at least six months prior to the visit 1, week -2 blood draw.
  • Frequent use (more than twice per month) of any non-study-related EPA/DHA containing enriched foods (such as DHA-enriched eggs) within four months of visit 1, week -2 and avoidance of these enriched foods throughout the study period.
  • Use of ALA-containing seeds and oils (i.e., flaxseed, perilla seed, hemp, spirulina, walnut, mustard seed or black currant oil) for more than one week duration within four weeks of visit 1, week -2 and throughout the study period.
  • Consumption of fatty fish (salmon, herring, mackerel, albacore tuna, or sardines) more than twice per month within four months of visit 1, week -2. Unwillingness to avoid all fish, except shellfish and crustaceans, throughout the study period (Appendix 6. Note: it is recognized that many fish are not significant sources of omega-3 fatty acids; however, these foods are restricted to simplify the dietary advice in this low-dose SDA study).
  • Use of any dietary supplement known to alter lipid metabolism, including but not limited to: dietary fiber supplements, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, policosanols, niacin or its analogues at doses >50 mg/d, or others at the discretion of the Investigator within the four weeks prior to visit 1, week -2 or during the study. If a subject needs to discontinue a lipid-altering supplement(s), he/she will washout for four weeks prior to the screening visit procedures (visit 1, week -2).
  • Use of any weight-loss medication (prescription or over-the counter) including, but not limited to, lipase inhibitors [orlistat (alli™)], within four weeks prior to visit 1, week -2 and throughout the study.
  • Use of any weight loss supplement or program within four weeks of visit 1, week -2 and throughout the study.
  • Known allergy or sensitivity to study products or any ingredients of the study products (study products may contain milk, soy or wheat).
  • Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer (e.g., basal or squamous cell carcinoma of the skin).
  • Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
  • Current or recent history of (within 12 months of visit 1, week -2) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1 ½ oz distilled spirits).
  • Exposure to any non-registered drug product within 30 days prior to the screening visit (visit 1, week -2).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Provident Clinical Research & Consulting, Inc.

    Addison, Illinois

  • Meridien Research

    St. Petersburg, Florida, 33709

Other trials in United States

About this study

Official title: A Randomized, Controlled Trial to Assess the Effects of Stearidonic Acid-Containing Foods on Eicosapentaenoic Acid Levels of Red Blood Cells and the Omega-3 Index

The purpose of this clinical trial is to evaluate whether the omega-3 fatty acid stearidonic acid (SDA), when used as a food ingredient, increases the level of the long-chain omega-3 fatty acid eicosapentaenoic acid (EPA) in red blood cell (RBC) membranes in men and women.

Being tested
SDA soybean oil-containing foods, High-oleic sunflower oil containing foods, Eicosapentaenoic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDA soybean oil-containing foodsOther

    3 servings per day of foods containing 500 mg each SDA soybean oil plus 3 x 500 mg high-oleic sunflower oil in softgels per day.

  • High-oleic sunflower oil containing foodsOther

    3 servings per day of foods containing 500 mg high-oleic sunflower oil plus 3 x 500 mg high-oleic sunflower oil in softgels per day

  • Eicosapentaenoic acidOther

    3 x 500 mg per day of Eicosapentaenoic acid as an ethyl ester in softgels plus 3 servings per day of high-oleic sunflower oil-containing foods

Study groups in NCT01369550
Study groupRoleWhat they receive
High-oleic sunflower oil-containing foodsPlacebo comparatorSubjects will consume 3 servings of foods containing high-oleic sunflower oil plus 3x500 mg high-oleic sunflower oils softgels per day.
Receives: Other: High-oleic sunflower oil containing foods
Eicosapentaenoic acidActive comparatorSubjects will consume 3 x 500 mg eicosapentaenoic acid ethyl ester in softgels plus 3 servings of high-oleic sunflower oil-containing foods per day
Receives: Other: Eicosapentaenoic acid
SDA soybean oil-containing foodsExperimentalSubjects in this arm will consume 3 servings of SDA soybean oil-containing foods plus 3 x 500 mg high-oleic sunflower oil softgels per day.
Receives: Other: SDA soybean oil-containing foods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EPA as a percent of total of fatty acids in red blood cell membranes

    Measured: 12 weeks

  2. Omega-3 Index

    Sum of EPA + DHA as a % of total fatty acids in the red blood cell membrane

    Measured: 12 weeks

Secondary outcomes (10)

  1. Fasting Triglycerides

    Measured: 12 weeks

  2. Fasting Insulin

    Measured: 12 weeks

  3. HOMA-IR

    Homeostasis model assessment of insulin resistence

    Measured: 12 weeks

  4. HOMA-%B

    Homeostasis model assessment - Beta-cell function

    Measured: 12 weeks

  5. SDA as a percent of total fatty acids in the red blood cell

    Measured: 12 weeks

  6. Docosapentaenoic acid (DPA) as a percent of total fatty acids in the red blood cell membrane

    Measured: 12 weeks

  7. Arachidonic acid (AA) as a percent of total fatty acids in red blood cell membranes

    Measured: 12 weeks

  8. Fasting serum chemistry

    Standard panel containing: glucose, calcium, sodium, potassium, BUN, creatinine, ALP, ALT, AST, GGT, Total bilirubin, BUN:creatinine ratio, amylase, uric acid, CPK.

    Measured: 12 weeks

  9. Fasting Hematology Profile

    Standard panel containing: WBC count, WBC with differential, RBC count, hemoglobin, hematocrit,platelet count

    Measured: 12 weeks

  10. Fasting lipid panel

    Total cholesterol, LDL-C, HDL-C, non-HDL-C, TC/HDL-C

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2011 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369550
Sponsor's protocol ID
PCR-10-263
Other IDs
PRV-10001
Status last verified
Jun 2011
First submitted
6 Jun 2011
Last updated
9 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing SDA soybean oil-containing foods, High-oleic sunflower oil containing foods and Eicosapentaenoic acid in people with Healthy Volunteers and Markers of Cardiovascular Risk, run by Monsanto Company, LLC at 2 sites 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 7 inclusion and 23 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

EPA as a percent of total of fatty acids in red blood cell membranes (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369550.

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 9 Jun 2011.

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