HypercholesterolemiaPhase 3NCT02609295
Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects
A Phase 3 study testing ALA group in people with Hypercholesterolemia, run by Yonsei University at 1 site in South Korea.
Trial summary
This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity. Read more about this study
- Who is it for?
- Ages 40 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- ALA group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2015to Aug 2015
- Phase
- Phase 3
- 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 40 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate and sign in informed consent form
- Adults aged 40-70
- Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)
Who cannot join
- Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week
- Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment
- Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study
- Pregnant or lactating women, alcoholic, mental patient
- Judged to be inappropriate for the study by the investigator after reviewing other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of α-linolenic Acid Supplementation in the Form of Perilla Oil on Collagen-epinephrine Closure Time, Activated Partial Thromboplastin Time and Lp-PLA2 Activities in Nondiabetic and Hypercholesterolemic Subjects
This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.
Read the detailed description
An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group [1.2 g (two capsules) of perilla oil daily; 497 mg ALA] and a placebo group (1.2 g of medium-chain triglyceride oil daily).
- Conditions
- Hypercholesterolemia
- Being tested
- Placebo, ALA group
- Keywords
- α-linolenic acid, perilla oil, aPTT, Collagen-epinephrine closure time, Lp-PLA2
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
1.2 g (two capsules) of medium-chain triglyceride (MCT) oil
ALA groupDietary supplement
1.2 g (two capsules) of perilla oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily Receives: Dietary Supplement: Placebo |
| ALA group | Experimental | Individuals who consumed 1.2 g (two capsules) of perilla oil daily Receives: Dietary Supplement: ALA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen-Epinephrine Closure Time (C-EPI CT)
Measured: Baseline
Collagen-Epinephrine Closure Time (C-EPI CT)
Measured: 8-week follow up
Secondary outcomes (6)
Prothrombin Time (PT)
Measured: Baseline
Prothrombin Time (PT)
Measured: 8-week follow up
Activated partial thromboplastin time (aPTT)
Measured: Baseline
Activated partial thromboplastin time (aPTT)
Measured: 8-week follow up
Fibrinogen
Measured: Baseline
Fibrinogen
Measured: 8-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609295
- Sponsor's protocol ID
- HP-ALA-hyperchol
- Status last verified
- Jan 2016
- First submitted
- 16 Nov 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of α-linolenic Acid Supplementation in the Form of Perilla Oil on Collagen-epinephrine Closure Time, Activated Partial Thromboplastin Time and Lp-PLA2 Activities in Nondiabetic and Hypercholesterolemic Subjects
- ClinicalTrials.gov ID
- NCT02609295
- Acronym / sponsor ID
- HP-ALA-hyperchol
- Conditions
- Hypercholesterolemia
- Keywords
- α-linolenic acid, perilla oil, aPTT, Collagen-epinephrine closure time, Lp-PLA2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Nov 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.
This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.
Detailed description
An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group [1.2 g (two capsules) of perilla oil daily; 497 mg ALA] and a placebo group (1.2 g of medium-chain triglyceride oil daily).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIndividuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily |
| ALA group | Experimental | Dietary Supplement: ALA groupIndividuals who consumed 1.2 g (two capsules) of perilla oil daily |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily agree to participate and sign in informed consent form
- Adults aged 40-70
- Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)
Key exclusion criteria (5 listed)
- Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week
- Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment
- Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study
- Pregnant or lactating women, alcoholic, mental patient
- Judged to be inappropriate for the study by the investigator after reviewing other reasons
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 |
|---|---|---|
| Placebo1.2 g (two capsules) of medium-chain triglyceride (MCT) oil | Dietary supplement | Placebo |
| ALA group1.2 g (two capsules) of perilla oil | Dietary supplement | ALA group |
Primary outcome
Collagen-Epinephrine Closure Time (C-EPI CT)
Time frame: Baseline
Collagen-Epinephrine Closure Time (C-EPI CT)
Time frame: 8-week follow up
6 secondary outcomes
Prothrombin Time (PT)
Time frame: Baseline
Prothrombin Time (PT)
Time frame: 8-week follow up
Activated partial thromboplastin time (aPTT)
Time frame: Baseline
Activated partial thromboplastin time (aPTT)
Time frame: 8-week follow up
Fibrinogen
Time frame: Baseline
Fibrinogen
Time frame: 8-week follow up
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 22 Jan 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?
A Phase 3 study testing ALA group in people with Hypercholesterolemia, run by Yonsei University at 1 site in South Korea.
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 5 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 22 Jan 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Collagen-Epinephrine Closure Time (C-EPI CT) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2016.