Soybean Oil Trial of cArdiovascular Risk (STAR)
Primary Purpose
Cardiovascular Disease, Diabetes, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soybean oil
High-oleic soybean oil
High-oleic soybean oil + fully hydrogenated soybean oil
Palm olein + palm stearin
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Disease focused on measuring Prevention
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
Sites / Locations
- USDA-ARS, Beltsville Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Active Comparator
Arm Label
Soybean oil
High-oleic soybean oil
High-oleic soybean oil + fully hydrogenated soybean oil
Palm olein + palm stearin
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in systemic inflammation
Markers of systemic inflammation will be measured, such as IL-6, CRP, and isoprostanes.
Change in hemostasis
Markers of hemostasis will be measured, such as fibrinogen and factor VIIc.
Change in oxidation
Markers of oxidation will be measured, such as 4-hydroxynonenal, vitamin E, oxidized LDL, lipid hydroperoxides, and malondialdehyde.
Change in vascular health
Markers of vascular health will be measured, such as ICAM, VCAM, eSelectin, and blood pressure.
Change in glucose
Fasting blood glucose will be measured.
Change in insulin
Fasting insulin will be measured.
Change in body composition
Dual-energy x-ray absorptiometry (DEXA; fat and lean mass, visceral fat) will be measured.
Change in waist circumference
Full Information
NCT ID
NCT02404207
First Posted
March 18, 2015
Last Updated
May 10, 2016
Sponsor
USDA Beltsville Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02404207
Brief Title
Soybean Oil Trial of cArdiovascular Risk
Acronym
STAR
Official Title
The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Beltsville Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Diabetes, Metabolic Syndrome
Keywords
Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soybean oil
Arm Type
Active Comparator
Arm Title
High-oleic soybean oil
Arm Type
Experimental
Arm Title
High-oleic soybean oil + fully hydrogenated soybean oil
Arm Type
Experimental
Arm Title
Palm olein + palm stearin
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Soybean oil
Intervention Description
Participants will be fed soybean oil as part of a controlled (typical American) diet.
Intervention Type
Other
Intervention Name(s)
High-oleic soybean oil
Intervention Description
Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
Intervention Type
Other
Intervention Name(s)
High-oleic soybean oil + fully hydrogenated soybean oil
Intervention Description
Participants will be fed a blend of high-oleic soybean oil and fully hydrogenated soybean oil as part of a controlled (typical American) diet.
Intervention Type
Other
Intervention Name(s)
Palm olein + palm stearin
Intervention Description
Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.
Primary Outcome Measure Information:
Title
Change in lipid profile
Description
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.
Time Frame
At baseline and end of each 4-week diet period
Secondary Outcome Measure Information:
Title
Change in systemic inflammation
Description
Markers of systemic inflammation will be measured, such as IL-6, CRP, and isoprostanes.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in hemostasis
Description
Markers of hemostasis will be measured, such as fibrinogen and factor VIIc.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in oxidation
Description
Markers of oxidation will be measured, such as 4-hydroxynonenal, vitamin E, oxidized LDL, lipid hydroperoxides, and malondialdehyde.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in vascular health
Description
Markers of vascular health will be measured, such as ICAM, VCAM, eSelectin, and blood pressure.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in glucose
Description
Fasting blood glucose will be measured.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in insulin
Description
Fasting insulin will be measured.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in body composition
Description
Dual-energy x-ray absorptiometry (DEXA; fat and lean mass, visceral fat) will be measured.
Time Frame
At baseline and end of each 4-week diet period
Title
Change in waist circumference
Time Frame
At baseline and end of each 4-week diet period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
USDA-ARS, Beltsville Human Nutrition Research Center
City
Beltsville
State/Province
Maryland
ZIP/Postal Code
20705
Country
United States
12. IPD Sharing Statement
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Soybean Oil Trial of cArdiovascular Risk
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