HypercholesterolemiaNCT01925716
Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids
A study testing Corn oil and Olive oil in people with Hypercholesterolemia, run by ACH Food Companies, Inc..
Trial summary
The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Corn oil and Olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Aug 2013
- 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 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting LDL-C level equal to or greater than 130 mg/dL and less than 200 mg/dL at visit 1
- Fasting triglycerides less than or equal to 350 mg/dL at visit 1
Who cannot join
- Has coronary heart disease or coronary heart disease risk risk equivalent, such as diabetes, atherosclerosis, etc
- Taking lipid medications intended to alter the lipids profile, including but not limited to statins, bile acid sequestrants, etc.
- Uncontrolled hypertension (systolic greater than or equal to 160 mm Hg or diastolic greater than or equal to 100 mm Hg)
About this study
Official title: A Randomized Double Blind Controlled Crossover Trial to Assess the Effects of Dietary Oils on Fasting Lipoprotein Lipids
The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol
- Conditions
- Hypercholesterolemia
- Being tested
- Corn oil, Olive oil
- Keywords
- cholesterol,LDL, vegetable oils, heart diseases
- Medical subject headings
- Hypercholesterolemia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corn oilOther
corn oil 56 g/day for 21 days
Olive oilOther
olive oil 56 g /day for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Corn oil/olive oil | Experimental | Corn oil 56 g per day for 21 days followed by olive oil 56 g for 21 days Receives: Other: Corn oil; Other: Olive oil |
| Olive Oil/Corn Oil | Experimental | olive oil, 56g per day for 21 days followed by corn oil, 56 g for 21 days Receives: Other: Corn oil; Other: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein cholesterol
Measured: Time Frame: baseline (average days -7 and 0) and the end of each treatment period [Treatment 1 averages of days 19 and 21and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
Secondary outcomes (1)
total cholesterol
Measured: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACH Food Companies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Sponsor
- Investigators
- Kevin C Maki, PhD, Study director, Biofortis Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925716
- Sponsor's protocol ID
- PRV-1303
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Maki KC, Lawless AL, Kelley KM, Kaden VN, Geiger CJ, Dicklin MR. Corn oil improves the plasma lipoprotein lipid profile compared with extra-virgin olive oil consumption in men and women with elevated cholesterol: results from a randomized controlled feeding trial. J Clin Lipidol. 2015 Jan-Feb;9(1):49-57. doi: 10.1016/j.jacl.2014.10.006. Epub 2014 Oct 23.
PubMed 25670360
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Controlled Crossover Trial to Assess the Effects of Dietary Oils on Fasting Lipoprotein Lipids
- ClinicalTrials.gov ID
- NCT01925716
- Acronym / sponsor ID
- PRV-1303
- Conditions
- Hypercholesterolemia
- Keywords
- cholesterol,LDL, vegetable oils, heart diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- ACH Food Companies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PepsiCo Global R&D
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Aug 2013 (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.
The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corn oil/olive oil | Experimental | Other: Corn oil, Other: Olive oilCorn oil 56 g per day for 21 days followed by olive oil 56 g for 21 days |
| Olive Oil/Corn Oil | Experimental | Other: Corn oil, Other: Olive oilolive oil, 56g per day for 21 days followed by corn oil, 56 g for 21 days |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting LDL-C level equal to or greater than 130 mg/dL and less than 200 mg/dL at visit 1
- Fasting triglycerides less than or equal to 350 mg/dL at visit 1
Key exclusion criteria (3 listed)
- Has coronary heart disease or coronary heart disease risk risk equivalent, such as diabetes, atherosclerosis, etc
- Taking lipid medications intended to alter the lipids profile, including but not limited to statins, bile acid sequestrants, etc.
- Uncontrolled hypertension (systolic greater than or equal to 160 mm Hg or diastolic greater than or equal to 100 mm Hg)
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 |
|---|---|---|
| Corn oilcorn oil 56 g/day for 21 days | Other | Corn oil/olive oil, Olive Oil/Corn Oil |
| Olive oilolive oil 56 g /day for 21 days | Other | Corn oil/olive oil, Olive Oil/Corn Oil |
Primary outcome
Low Density Lipoprotein cholesterol
Time frame: Time Frame: baseline (average days -7 and 0) and the end of each treatment period [Treatment 1 averages of days 19 and 21and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
1 secondary outcome
total cholesterol
Time frame: baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
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 21 Aug 2013.
- Derived from this study: PubMed 25670360Maki KC, Lawless AL, Kelley KM, Kaden VN, Geiger CJ, Dicklin MR. Corn oil improves the plasma lipoprotein lipid profile compared with extra-virgin olive oil consumption in men and women with elevated cholesterol: results from a randomized controlled feeding trial. J Clin Lipidol. 2015 Jan-Feb;9(1):49-57. doi: 10.1016/j.jacl.2014.10.006. Epub 2014 Oct 23.
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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.
Kevin C Maki, PhD study director
Biofortis Clinical Research, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Corn oil and Olive oil in people with Hypercholesterolemia, run by ACH Food Companies, Inc..
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 2 inclusion and 3 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 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Low Density Lipoprotein cholesterol (time frame: Time Frame: baseline (average days -7 and 0) and the end of each treatment period [Treatment 1 averages of days 19 and 21and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks). 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 NCT01925716, which also lists 1 linked publication.
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 21 Aug 2013.