HypercholesterolemiaPhytoNCT06127732
Phytosterol Supplementation and Lipoprotein Subfractions
A study testing Phytosterol supplements in people with Hypercholesterolemia and Primary Prevention, run by Federal University of São Paulo at 2 sites in Brazil.
Trial summary
The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Primary Prevention
- What is being tested?
- Phytosterol supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 May 2017to 10 Jan 2022
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants of both sexes, aged >18 and <65 years, literate, in primary prevention of cardiovascular disease, with LDL-c ≥130mg/dL and <190 mg/dL and triglycerides <400 mg/dL.
Who cannot join
- secondary causes of dyslipidemia, renal (creatinine > 2mg/dL), hepatic (AST or ALT > 1.5 ULN), or metabolic (HbA1c >8.0%) dysfunction, with BMI <18.5 or >40 Kg/m2, recent surgery, disabsortive syndrome, malignancies, under lipid-lowering therapy, unable or unwilling to participate, or with less than 80% adherence to phytosterols
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of Sao Paulo
São Paulo, Other
Federal University of Sao Paulo
São Paulo, São Paulo, 04039030
About this study
Official title: Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study
The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects.
The main questions it aims to answer are:
- do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?
- do phytosterols modify the quality of LDL?
Participants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where treatments were switched for another 12-weeks.
Read the detailed description
Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry criteria, 10 were excluded for not following the protocol. Twenty-three individuals were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments were switched for another 12-w.
Study was prospective, randomized, open label, cross-over, with parallel arms and blinded endpoints.
Anthropometry, food consumption and laboratory parameters were evaluated every 12-w.
HDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel (Lipoprint System®).
Plasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).
- Conditions
- Hypercholesterolemia, Primary Prevention
- Being tested
- Phytosterol supplements
- Keywords
- Phytosterols, Lipoproteins, LDL-subfractions, HDL-subfractions
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytosterol supplementsDietary supplement
Participants were randomized into two groups to receive diet plus phytosterols (DP) for 12 weeks, followed by a 7-day washout period with a second period of intervention, where treatments were switched, and participants received diet alone (D) and were followed for another 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Phytosterol | Experimental | Participants received diet plus phytosterols (2.6 g of phytosterols per day) prescribed and supplied in 650 mg gelatin capsules, to be used four capsules a day along with meals(Fitocor®, Farmoquímica, Brazil) and divided into two meals.for 12 weeks. Receives: Dietary Supplement: Phytosterol supplements |
| Control: diet alone | No intervention | Participants received diet alone recommended for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total and LDL-cholesterol
Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol
Measured: 12 weeks
Secondary outcomes (3)
Change in LDL subfractions
Phytosterol suplementation can modify LDL subfractions
Measured: 12 weeks
Change in HDL subfractions
Phytosterol suplementation can modify HDL subfractions
Measured: 12 weeks
Improvement on quality of LDL particle
Phytosterol supplementation can improve the quality of LDL particle
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 May 2017
- Primary completion30 Sep 2018
- Study completion10 Jan 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Maria Cristina de Oliveira Izar, Federal University of São Paulo
- Investigators
- Maria C Izar, M.D., Ph.D., Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127732
- Sponsor's protocol ID
- 042778/2017
- Acronym
- Phyto
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon request.
Publications
Machado VA, Santisteban ARN, Martins CM, Damasceno NRT, Fonseca FA, Neto AMF, Izar MC. Effects of phytosterol supplementation on lipoprotein subfractions and LDL particle quality. Sci Rep. 2024 May 15;14(1):11108. doi: 10.1038/s41598-024-61897-4.
PubMed 38750162
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study
- ClinicalTrials.gov ID
- NCT06127732
- Acronym / sponsor ID
- Phyto / 042778/2017
- Conditions
- Hypercholesterolemia, Primary Prevention
- Keywords
- Phytosterols, Lipoproteins, LDL-subfractions, HDL-subfractions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 13 Nov 2023 (actual)
- 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 goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects.
The main questions it aims to answer are:
- do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?
- do phytosterols modify the quality of LDL?
Participants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where treatments were switched for another 12-weeks.
Detailed description
Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry criteria, 10 were excluded for not following the protocol. Twenty-three individuals were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments were switched for another 12-w.
Study was prospective, randomized, open label, cross-over, with parallel arms and blinded endpoints.
Anthropometry, food consumption and laboratory parameters were evaluated every 12-w.
HDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel (Lipoprint System®).
Plasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.
| Arm | Type | Receives |
|---|---|---|
| Phytosterol | Experimental | Dietary Supplement: Phytosterol supplementsParticipants received diet plus phytosterols (2.6 g of phytosterols per day) prescribed and supplied in 650 mg gelatin capsules, to be used four capsules a day along with meals(Fitocor®, Farmoquímica, Brazil) and divided into two meals.for 12 weeks. |
| Control: diet alone | No intervention | –Participants received diet alone recommended for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants of both sexes, aged >18 and <65 years, literate, in primary prevention of cardiovascular disease, with LDL-c ≥130mg/dL and <190 mg/dL and triglycerides <400 mg/dL.
Key exclusion criteria (1 listed)
- secondary causes of dyslipidemia, renal (creatinine > 2mg/dL), hepatic (AST or ALT > 1.5 ULN), or metabolic (HbA1c >8.0%) dysfunction, with BMI <18.5 or >40 Kg/m2, recent surgery, disabsortive syndrome, malignancies, under lipid-lowering therapy, unable or unwilling to participate, or with less than 80% adherence to phytosterols
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 |
|---|---|---|
| Phytosterol supplementsParticipants were randomized into two groups to receive diet plus phytosterols (DP) for 12 weeks, followed by a 7-day washout period with a second period of intervention, where treatments were switched, and participants received diet alone (D) and were followed for another 12 weeks. | Dietary supplement | Phytosterol |
Primary outcome
Change in total and LDL-cholesterol
Time frame: 12 weeks
Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol
3 secondary outcomes
Change in LDL subfractions
Time frame: 12 weeks
Change in HDL subfractions
Time frame: 12 weeks
Improvement on quality of LDL particle
Time frame: 12 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 13 Nov 2023.
- Derived from this study: PubMed 38750162Machado VA, Santisteban ARN, Martins CM, Damasceno NRT, Fonseca FA, Neto AMF, Izar MC. Effects of phytosterol supplementation on lipoprotein subfractions and LDL particle quality. Sci Rep. 2024 May 15;14(1):11108. doi: 10.1038/s41598-024-61897-4.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request.
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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.
Maria C Izar, M.D., Ph.D. principal investigator
Federal University of São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytosterol supplements in people with Hypercholesterolemia and Primary Prevention, run by Federal University of São Paulo at 2 sites in Brazil.
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 1 inclusion and 1 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 total and LDL-cholesterol (time frame: 12 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 NCT06127732, 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 13 Nov 2023.