Soybean Oil Trial of cArdiovascular Risk (STAR)

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Diabetes; Metabolic Syndrome; Cardiovascular Disease

Treatments: Other: Palm olein + palm stearin; Other: High-oleic soybean oil + fully hydrogenated soybean oil; Other: High-oleic soybean oil; Other: Soybean oil

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02404207

HS50

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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
• Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 4 patient groups

Soybean oil

Active Comparator group

Treatment:

Other: Soybean oil

High-oleic soybean oil

Experimental group

Treatment:

Other: High-oleic soybean oil

High-oleic soybean oil + fully hydrogenated soybean oil

Experimental group

Treatment:

Other: High-oleic soybean oil + fully hydrogenated soybean oil

Palm olein + palm stearin

Active Comparator group

Treatment:

Other: Palm olein + palm stearin