Healthy SubjectsPhase 3NCT02753907
Impact of an 8-week Linoleic Acid Intake in Soy Oil on Lp-PLA2 Activity in Healthy Adults
A Phase 3 study testing Low LA and High LA in people with Healthy Subjects, run by Yonsei University at 1 site in South Korea.
Trial summary
Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30 kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50) maintained usual food intake; a high LA group (n=50)… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Low LA and High LA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Sep 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30 to 65 years at beginning of study
- Subjects with BMI 18.5 to 30 kg/m^2
Who cannot join
- Use of any medication or supplements that alter lipid metabolism.
- Presence of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, chronic disease of the gastrointestinal tract, cerebrovascular disease, pancreatitis or cancer.
- Women who pregnant or lactating.
- Drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, 120-749
About this study
Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30 kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50) maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8 week alongside other cardiovascular disease risk factors.
- Conditions
- Healthy Subjects
- Being tested
- Low LA, High LA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low LADietary supplement
Individuals who replaced 10 mL soy oil with one apple
High LADietary supplement
Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9g (9 of 1.1g capsules, 3 capsules at every 3 meals a day) of soy oil as a supplement
| Study group | Role | What they receive |
|---|---|---|
| Low LA (linoleic acid) | Experimental | Individuals who replaced 10 mL soy oil with one apple Receives: Dietary Supplement: Low LA |
| Medium LA | No intervention | Individuals who maintained their usual food intake |
| High LA | Experimental | Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9 g of soy oil as a supplement Receives: Dietary Supplement: High LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lp-PLA2 activity (nmol/mL/min)
Measured: At baseline and end of each 8-week diet period
Secondary outcomes (4)
Change in total cholesterol (mg/dL)
Measured: At baseline and end of each 8-week diet period
Change in LDL cholesterol (mg/dL)
Lipids and lipoproteins, such as total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Apo A-I, Apo B
Measured: At baseline and end of each 8-week diet period
Change in HDL cholesterol (mg/dL)
Measured: At baseline and end of each 8-week diet period
Change in triglyceride (mg/dL)
Measured: At baseline and end of each 8-week diet period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2015
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 Healthy SubjectsStudies 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
- None (open label)
- Enrolment
- 150 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
- NCT02753907
- Sponsor's protocol ID
- LA_fu
- Status last verified
- Apr 2016
- First submitted
- 22 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
Publications
Kim M, Kim M, Lee A, Yoo HJ, Her JS, Jee SH, Lee JH. Impact of 8-week linoleic acid intake in soy oil on Lp-PLA2 activity in healthy adults. Nutr Metab (Lond). 2017 May 8;14:32. doi: 10.1186/s12986-017-0186-2. eCollection 2017.
PubMed 28503188
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an 8-week Linoleic Acid Intake in Soy Oil on Lp-PLA2 Activity in Healthy Adults
- ClinicalTrials.gov ID
- NCT02753907
- Acronym / sponsor ID
- LA_fu
- Conditions
- Healthy Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 28 Apr 2016 (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.
Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30 kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50) maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8 week alongside other cardiovascular disease risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low LA (linoleic acid) | Experimental | Dietary Supplement: Low LAIndividuals who replaced 10 mL soy oil with one apple |
| Medium LA | No intervention | –Individuals who maintained their usual food intake |
| High LA | Experimental | Dietary Supplement: High LAIndividuals who reduced 1/3 cup of cooked refined rice and consumed 9.9 g of soy oil as a supplement |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 30 to 65 years at beginning of study
- Subjects with BMI 18.5 to 30 kg/m^2
Key exclusion criteria (4 listed)
- Use of any medication or supplements that alter lipid metabolism.
- Presence of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, chronic disease of the gastrointestinal tract, cerebrovascular disease, pancreatitis or cancer.
- Women who pregnant or lactating.
- Drug or alcohol abuse.
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 |
|---|---|---|
| Low LAIndividuals who replaced 10 mL soy oil with one apple | Dietary supplement | Low LA (linoleic acid) |
| High LAIndividuals who reduced 1/3 cup of cooked refined rice and consumed 9.9g (9 of 1.1g capsules, 3 capsules at every 3 meals a day) of soy oil as a supplement | Dietary supplement | High LA |
Primary outcome
Change in Lp-PLA2 activity (nmol/mL/min)
Time frame: At baseline and end of each 8-week diet period
4 secondary outcomes
Change in total cholesterol (mg/dL)
Time frame: At baseline and end of each 8-week diet period
Change in LDL cholesterol (mg/dL)
Time frame: At baseline and end of each 8-week diet period
Change in HDL cholesterol (mg/dL)
Time frame: At baseline and end of each 8-week diet period
Change in triglyceride (mg/dL)
Time frame: At baseline and end of each 8-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 28 Apr 2016.
- Derived from this study: PubMed 28503188Kim M, Kim M, Lee A, Yoo HJ, Her JS, Jee SH, Lee JH. Impact of 8-week linoleic acid intake in soy oil on Lp-PLA2 activity in healthy adults. Nutr Metab (Lond). 2017 May 8;14:32. doi: 10.1186/s12986-017-0186-2. eCollection 2017.
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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 Low LA and High LA in people with Healthy Subjects, 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 2 inclusion and 4 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 28 Apr 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. 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?
Change in Lp-PLA2 activity (nmol/mL/min) (time frame: At baseline and end of each 8-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 NCT02753907, 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 28 Apr 2016.