Soybean Oil Trial of cArdiovascular Risk
STAR
The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
The study will determine the effects of different types of soybean oils on biomarkers of risk for cardiovascular disease and diabetes. There will be four 4-week diet periods in which participants will consume the following oils, within the context of a controlled diet: soybean oil, high-oleic soybean oil, blend of high oleic soybean oil \& fully hydrogenated soybean oil, and blend of palm olein \& palm stearin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 12, 2016
May 1, 2016
7 months
March 18, 2015
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in lipid profile
Lipids and lipoproteins, such as total cholesterol, LDL-cholesterol, HDL-cholesterol, triacylglycerides, Apo AI, ApoAII, ApoB, apolipoprotein size, and cholesterol ester composition, will be measured in the blood.
At baseline and end of each 4-week diet period
Secondary Outcomes (8)
Change in systemic inflammation
At baseline and end of each 4-week diet period
Change in hemostasis
At baseline and end of each 4-week diet period
Change in oxidation
At baseline and end of each 4-week diet period
Change in vascular health
At baseline and end of each 4-week diet period
Change in glucose
At baseline and end of each 4-week diet period
- +3 more secondary outcomes
Study Arms (4)
Soybean oil
ACTIVE COMPARATORHigh-oleic soybean oil
EXPERIMENTALHigh-oleic soybean oil + fully hydrogenated soybean oil
EXPERIMENTALPalm olein + palm stearin
ACTIVE COMPARATORInterventions
Participants will be fed soybean oil as part of a controlled (typical American) diet.
Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
Participants will be fed a blend of high-oleic soybean oil and fully hydrogenated soybean oil as part of a controlled (typical American) diet.
Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.
Eligibility Criteria
You may qualify if:
- Age 30 to 70 years at beginning of study
- LDL-cholesterol between 120 and 160 mg/dl
- Less than 2+ risk factors for coronary heart disease (risk factors include: blood pressure \> 140/90 mm Hg or on blood pressure medication; HDL-cholesterol \< 40 mg/dl; age greater than 45 yrs for males \& greater than 55 yrs for females; family history of premature coronary heart disease (CHD in male first degree relative \<55 years; CHD in female first degree relative \<65 years)
You may not qualify if:
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Use of prescription or over-the-counter medications or supplements that alter lipid metabolism.
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of bariatric or certain other surgeries related to weight control
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- Smokers or other tobacco users (during 6 months prior to the start of the study)
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Known (self-reported) allergy or adverse reaction to study foods
- Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months)
- Unable or unwilling to give informed consent or communicate with study staff
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Physiologist
Study Record Dates
First Submitted
March 18, 2015
First Posted
March 31, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
May 12, 2016
Record last verified: 2016-05