Phytosterol Supplementation and Lipoprotein Subfractions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2022-01-10

Brief Summary

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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.

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Detailed Description

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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

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Hypercholesterolemia Primary Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Phytosterol supplements

Intervention Type DIETARY_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.

Control: diet alone

Participants received diet alone recommended for 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes