- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404207
Soybean Oil Trial of cArdiovascular Risk (STAR)
May 10, 2016 updated by: David Baer, USDA Beltsville Human Nutrition Research Center
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Beltsville, Maryland, United States, 20705
- USDA-ARS, Beltsville Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Soybean oil
|
Participants will be fed soybean oil as part of a controlled (typical American) diet.
|
Experimental: High-oleic soybean oil
|
Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
|
Experimental: 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.
|
Active Comparator: Palm olein + palm stearin
|
Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lipid profile
Time Frame: 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.
|
At baseline and end of each 4-week diet period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in systemic inflammation
Time Frame: At baseline and end of each 4-week diet period
|
Markers of systemic inflammation will be measured, such as IL-6, CRP, and isoprostanes.
|
At baseline and end of each 4-week diet period
|
Change in hemostasis
Time Frame: At baseline and end of each 4-week diet period
|
Markers of hemostasis will be measured, such as fibrinogen and factor VIIc.
|
At baseline and end of each 4-week diet period
|
Change in oxidation
Time Frame: 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.
|
At baseline and end of each 4-week diet period
|
Change in vascular health
Time Frame: 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.
|
At baseline and end of each 4-week diet period
|
Change in glucose
Time Frame: At baseline and end of each 4-week diet period
|
Fasting blood glucose will be measured.
|
At baseline and end of each 4-week diet period
|
Change in insulin
Time Frame: At baseline and end of each 4-week diet period
|
Fasting insulin will be measured.
|
At baseline and end of each 4-week diet period
|
Change in body composition
Time Frame: 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.
|
At baseline and end of each 4-week diet period
|
Change in waist circumference
Time Frame: At baseline and end of each 4-week diet period
|
At baseline and end of each 4-week diet period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 31, 2015
Study Record Updates
Last Update Posted (Estimate)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS50
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
-
Penn State UniversityAlmond Board of California; The Hershey CompanyCompletedCardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentCompleted
-
Aziyo Biologics, Inc.CompletedCardiovascular DiseaseUnited States
-
Monash UniversityCompletedCardiovascular DiseaseAustralia
Clinical Trials on Soybean oil
-
Academia Sinica, TaiwanCompletedColorectal Neoplasms
-
Johane AllardUniversity of Alberta; Hamilton Health Sciences Corporation; St. Paul's Hospital... and other collaboratorsTerminatedTotal Parenteral Nutrition-induced CholestasisCanada
-
University of California, DavisNational Institutes of Health (NIH); National Center for Complementary and...CompletedPolycystic Ovarian SyndromeUnited States
-
Maimónides Biomedical Research Institute of CórdobaCompleted
-
Purdue UniversityCompletedAbsorption of Carotenoids From VegetablesUnited States
-
Alexandra N. CareyCompletedHematopoietic Stem Cell TransplantationUnited States
-
Academia Sinica, TaiwanNot yet recruiting
-
Dr. Sami Ulus Children's HospitalCompletedRetinopathy of Prematurity | Neonatal CholestasisTurkey
-
University of MichiganTerminated
-
University of NairobiConsortium for Advanced Research Training in Africa (CARTA); Innovix Pharma...Completed