Clinical trial NCT02404207: Soybean Oil Trial of cArdiovascular Risk
Official title: The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Diabetes
Metabolic Syndrome
Keywords: Prevention
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2015-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in lipid profile
timeFrame: At baseline and end of each 4-week diet period
Secondary outcomes:
measure: Change in systemic inflammation
timeFrame: At baseline and end of each 4-week diet period
measure: Change in hemostasis
timeFrame: At baseline and end of each 4-week diet period
measure: Change in oxidation
timeFrame: At baseline and end of each 4-week diet period
measure: Change in vascular health
timeFrame: At baseline and end of each 4-week diet period
measure: Change in glucose
timeFrame: At baseline and end of each 4-week diet period
measure: Change in insulin
timeFrame: At baseline and end of each 4-week diet period
measure: Change in body composition
timeFrame: At baseline and end of each 4-week diet period
measure: Change in waist circumference
timeFrame: At baseline and end of each 4-week diet period
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS, Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: