Cardiovascular DiseaseSTARNCT02404207

Soybean Oil Trial of cArdiovascular Risk

A study testing Soybean oil, High-oleic soybean oil and High-oleic soybean oil + fully hydrogenated soybean oil in people with Cardiovascular Disease and Diabetes, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease, Diabetes, Metabolic Syndrome
What is being tested?: Soybean oil, High-oleic soybean oil and High-oleic soybean oil + fully hydrogenated soybean oil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705

Other trials in United States

About this study

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

Conditions: Cardiovascular Disease, Diabetes, Metabolic Syndrome
Being tested: Soybean oil, High-oleic soybean oil, High-oleic soybean oil + fully hydrogenated soybean oil, Palm olein + palm stearin
Keywords: Prevention
Medical subject headings: Cardiovascular Diseases, Diabetes Mellitus, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Soybean oilOther
Participants will be fed soybean oil as part of a controlled (typical American) diet.
High-oleic soybean oilOther
Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
High-oleic soybean oil + fully hydrogenated soybean oilOther
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 stearinOther
Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.

Study groups in NCT02404207
Study group	Role	What they receive
Soybean oil	Active comparator	Not described Receives: Other: Soybean oil
High-oleic soybean oil	Experimental	Not described Receives: Other: High-oleic soybean oil
High-oleic soybean oil + fully hydrogenated soybean oil	Experimental	Not described Receives: Other: High-oleic soybean oil + fully hydrogenated soybean oil
Palm olein + palm stearin	Active comparator	Not described Receives: Other: Palm olein + palm stearin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline and end of each 4-week diet period

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Oct 2015

First posted31 Mar 2015 (estimated)
Study startMar 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02404207
Sponsor's protocol ID: HS50
Acronym: STAR
Status last verified: May 2016
First submitted: 18 Mar 2015
Last updated: 12 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of High-Oleic Soybean Oil on Biomarkers of Risk for Metabolic Syndrome
ClinicalTrials.gov ID: NCT02404207
Acronym / sponsor ID: STAR / HS50
Conditions: Cardiovascular Disease, Diabetes, Metabolic Syndrome
Keywords: Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: USDA Beltsville Human Nutrition Research CenterUS federal agency
Study start: Mar 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 31 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Soybean oil	Active comparator	Other: Soybean oil
High-oleic soybean oil	Experimental	Other: High-oleic soybean oil
High-oleic soybean oil + fully hydrogenated soybean oil	Experimental	Other: High-oleic soybean oil + fully hydrogenated soybean oil
Palm olein + palm stearin	Active comparator	Other: Palm olein + palm stearin

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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)

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Soybean oilParticipants will be fed soybean oil as part of a controlled (typical American) diet.	Other	Soybean oil
High-oleic soybean oilParticipants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.	Other	High-oleic soybean oil
High-oleic soybean oil + fully hydrogenated soybean oilParticipants will be fed a blend of high-oleic soybean oil and fully hydrogenated soybean oil as part of a controlled (typical American) diet.	Other	High-oleic soybean oil + fully hydrogenated soybean oil
Palm olein + palm stearinParticipants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.	Other	Palm olein + palm stearin

Primary outcome

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.

8 secondary outcomes

Change in systemic inflammation
Time frame: 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
Change in oxidation
Time frame: 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
Change in glucose
Time frame: 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
Change in body composition
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lipid profile (time frame: At baseline and end of each 4-week diet period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02404207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.