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

NCT01369550 | Completed

• 2 other identifiers: PCR-10-263PRV-10001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteers; Markers of Cardiovascular Risk

Outcome Measures

Primary Outcomes (2)

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

  12 weeks

• Omega-3 Index

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

  12 weeks

Secondary Outcomes (10)

• Fasting Triglycerides

  12 weeks

• Fasting Insulin

  12 weeks

• HOMA-IR

  12 weeks

• HOMA-%B

  12 weeks

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

  12 weeks

Study Arms (3)

High-oleic sunflower oil-containing foods

PLACEBO COMPARATOR

Subjects will consume 3 servings of foods containing high-oleic sunflower oil plus 3x500 mg high-oleic sunflower oils softgels per day.

Other: High-oleic sunflower oil containing foods

Eicosapentaenoic acid

ACTIVE COMPARATOR

Subjects will consume 3 x 500 mg eicosapentaenoic acid ethyl ester in softgels plus 3 servings of high-oleic sunflower oil-containing foods per day

Other: Eicosapentaenoic acid

SDA soybean oil-containing foods

EXPERIMENTAL

Subjects 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.

Other: SDA soybean oil-containing foods

Interventions

SDA soybean oil-containing foods OTHER

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.

SDA soybean oil-containing foods

High-oleic sunflower oil containing foods OTHER

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

High-oleic sunflower oil-containing foods

Eicosapentaenoic acid OTHER

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

Eicosapentaenoic acid

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Monsanto Company, LLC: lead
• Solae, LLC: collaborator

Study Sites (2)

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Provident Clinical Research & Consulting, Inc.

Addison, Illinois, United States

Location

MeSH Terms

Interventions

Eicosapentaenoic Acid

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Kevin Maki, PhD

  Provident Clinical Research & Consulting, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 9, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

US (2)