Soybean Oil Trial of cArdiovascular Risk
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Endocrine |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
Healthy: | No |
Age Range: | 30 - 70 |
Updated: | 4/21/2016 |
Start Date: | March 2015 |
End Date: | October 2015 |
The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome
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.
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.
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
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