Soybean Oil Trial of cArdiovascular Risk

Diabetes Clinical Trial

— STAR  

Official title:

The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404207
• Other study ID #: HS50
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: October 14, 2015
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• Soybean oil
Participants will be fed soybean oil as part of a controlled (typical American) diet.
• High-oleic soybean oil
Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
• High-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.
• Palm olein + palm stearin
Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.

Locations

Country	Name	City	State
United States	USDA-ARS, Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lipid profile	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.	At baseline and end of each 4-week diet period	No
Secondary	Change in systemic inflammation	Markers of systemic inflammation will be measured, such as IL-6, CRP, and isoprostanes.	At baseline and end of each 4-week diet period	No
Secondary	Change in hemostasis	Markers of hemostasis will be measured, such as fibrinogen and factor VIIc.	At baseline and end of each 4-week diet period	No
Secondary	Change in oxidation	Markers of oxidation will be measured, such as 4-hydroxynonenal, vitamin E, oxidized LDL, lipid hydroperoxides, and malondialdehyde.	At baseline and end of each 4-week diet period	No
Secondary	Change in vascular health	Markers of vascular health will be measured, such as ICAM, VCAM, eSelectin, and blood pressure.	At baseline and end of each 4-week diet period	No
Secondary	Change in glucose	Fasting blood glucose will be measured.	At baseline and end of each 4-week diet period	No
Secondary	Change in insulin	Fasting insulin will be measured.	At baseline and end of each 4-week diet period	No
Secondary	Change in body composition	Dual-energy x-ray absorptiometry (DEXA; fat and lean mass, visceral fat) will be measured.	At baseline and end of each 4-week diet period	No
Secondary	Change in waist circumference		At baseline and end of each 4-week diet period	No

External Links

•   Study Volunteers Website: Click on "Current Studies" to get more information about the STAR study.