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Phytosterol Supplementation and Lipoprotein Subfractions

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT06127732
Collaborator
University of Sao Paulo (Other)
23
Enrollment
2
Locations
2
Arms
56.3
Actual Duration (Months)
11.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Phytosterol supplements
 N/A

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

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phytosterol

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.

Dietary Supplement: Phytosterol supplements
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.
No Intervention: Control: diet alone

Participants received diet alone recommended for 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change in total and LDL-cholesterol [12 weeks]

    Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol

Secondary Outcome Measures

  1. Change in LDL subfractions [12 weeks]

    Phytosterol suplementation can modify LDL subfractions

  2. Change in HDL subfractions [12 weeks]

    Phytosterol suplementation can modify HDL subfractions

  3. Improvement on quality of LDL particle [12 weeks]

    Phytosterol supplementation can improve the quality of LDL particle

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Sao Paulo Sao Paulo Other Brazil
2 Federal University of Sao Paulo Sao Paulo SP Brazil 04039030

Sponsors and Collaborators

  • Federal University of São Paulo
  • University of Sao Paulo

Investigators

  • Principal Investigator: Maria C Izar, M.D., Ph.D., Federal University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Cristina de Oliveira Izar, Assistant Professor of Medicine, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT06127732
Other Study ID Numbers:
  • 042778/2017
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Cristina de Oliveira Izar, Assistant Professor of Medicine, Federal University of São Paulo
Phytosterols
Lipoproteins
LDL-subfractions
HDL-subfractions
Additional relevant MeSH terms:
Hypercholesterolemia

Study Results

No Results Posted as of Nov 13, 2023