Soybean Oil Trial of cArdiovascular Risk

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Cardiovascular Disease; Diabetes
• Interventions: Other: High-oleic soybean oil; Other: Palm olein + palm stearin; Other: Soybean oil; Other: High-oleic soybean oil + fully hydrogenated soybean oil

• Registration Number: NCT02404207
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-31
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-oleic soybean oil	High-oleic soybean oil	-
Palm olein + palm stearin	Palm olein + palm stearin	-
Soybean oil	Soybean oil	-
High-oleic soybean oil + fully hydrogenated soybean oil	High-oleic soybean oil + fully hydrogenated soybean oil	-

Primary Outcome Measures

Name	Time	Method
Change in lipid profile	At baseline and end of each 4-week diet period	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.

Secondary Outcome Measures

Name	Time	Method
Change in insulin	At baseline and end of each 4-week diet period	Fasting insulin will be measured.
Change in vascular health	At baseline and end of each 4-week diet period	Markers of vascular health will be measured, such as ICAM, VCAM, eSelectin, and blood pressure.
Change in waist circumference	At baseline and end of each 4-week diet period
Change in hemostasis	At baseline and end of each 4-week diet period	Markers of hemostasis will be measured, such as fibrinogen and factor VIIc.
Change in oxidation	At baseline and end of each 4-week diet period	Markers of oxidation will be measured, such as 4-hydroxynonenal, vitamin E, oxidized LDL, lipid hydroperoxides, and malondialdehyde.
Change in glucose	At baseline and end of each 4-week diet period	Fasting blood glucose will be measured.
Change in body composition	At baseline and end of each 4-week diet period	Dual-energy x-ray absorptiometry (DEXA; fat and lean mass, visceral fat) will be measured.
Change in systemic inflammation	At baseline and end of each 4-week diet period	Markers of systemic inflammation will be measured, such as IL-6, CRP, and isoprostanes.

Trial Locations

Locations (1)

USDA-ARS, Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States