Cardiovascular Disease, Diabetes, Metabolic Syndrome
Conditions
Keywords
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.
Interventions
OTHERSoybean oil
Participants will be fed soybean oil as part of a controlled (typical American) diet.
OTHERHigh-oleic soybean oil
Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
OTHERHigh-oleic soybean oil + fully hydrogenated soybean oil
Participants will be fed a blend of high-oleic soybean oil and fully hydrogenated soybean oil as part of a controlled (typical American) diet.
OTHERPalm olein + palm stearin
Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.
Sponsors
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| Change in insulin | At baseline and end of each 4-week diet period | Fasting insulin 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 waist circumference | At baseline and end of each 4-week diet period | — |
| Change in glucose | At baseline and end of each 4-week diet period | Fasting blood glucose will be measured. |
Countries
United States
Outcome results
None listed