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Impact of dietary supplement use of phytosterol on LDL cholesterol in children and adolescents

Impact of phytosterol dietary supplementation on LDL cholesterol in dyslipidemic children and adolescents: double-blind, cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-48yb5y
Enrollment
Unknown
Registered
2018-02-01
Start date
2016-07-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypercholesterolemia

Interventions

The trial will consist of 30 children who will be randomized and allocated in two groups of 15. The intervention group will receive one capsule 800mg phytosterol before lunch and one 800mg phytosterol
Dietary supplement
E78.2

Sponsors

Hospital Universitário Pedro Ernesto
Lead Sponsor
Hospital Universitário Pedro Ernesto
Collaborator
Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
6 Years to 19 Years

Inclusion criteria

Inclusion criteria: Children and adolescents between 6 and 19 years old with LDL-cholesterol above 110mg / dL

Exclusion criteria

Exclusion criteria: Presence of heart disease, obesity, diabetes, nephrotic syndrome, systemic arterial hypertension, Down syndrome, Prader-Willi syndrome, hypothyroidism, Cushing's syndrome. Children and adolescents using lipid-lowering foods or medications such as corticosteroids, estrogens, progesterone, beta-blockers, and thiazides.

Design outcomes

Primary

MeasureTime frame
Significant reduction of LDL-cholesterol by the lipidogram at the end of the eighth week of intervention in the experimental group, with a reduction of five per cent in the intervention group.;Reduction in fasting insulin values, verified by the laboratory dosage at the end of the eighth week of intervention in the experimental group, with reduction of five per cent.;Reduction of systolic and diastolic blood pressure values, measured by electronic device calibrated and validated for research at the end of the eighth week of intervention in the experimental group, with a five per cent reduction.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactAna Karolina Moriel Tavares

Universidade do Estado do Rio de Janeiro

k.moriel2@gmail.com5521991632366

Outcome results

None listed

Source: REBEC (via WHO ICTRP)