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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06127732
Other study ID # 042778/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date January 10, 2022

Study information

Verified date November 2023
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 10, 2022
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Federal University of Sao Paulo Sao Paulo SP
Brazil University of Sao Paulo Sao Paulo Other

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in total and LDL-cholesterol Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol 12 weeks
Secondary Change in LDL subfractions Phytosterol suplementation can modify LDL subfractions 12 weeks
Secondary Change in HDL subfractions Phytosterol suplementation can modify HDL subfractions 12 weeks
Secondary Improvement on quality of LDL particle Phytosterol supplementation can improve the quality of LDL particle 12 weeks
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