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Completed

NCT Number: NCT02189200

Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects

Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Estadual de Cardiologia Aloysio de Castro - IECAC

Rio de Janeiro, 22261-010, Brazil

About this study

Objectives: To evaluate the effect of nutritional counseling associated with the consumption of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric parameters of subjects in secondary prevention, evaluate the quality of the diet and the intake of processed foods and ingredients added.

Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days. Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral lipid-lowering, since the dose reported in the early nutritional intervention was maintained during the study. Exclusion criteria: patients requiring reduction in daily fluid intake, supplement use in dietary fiber and gestation / lactation. Data collected: gender; age; education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC), neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS), HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo group (GPL). The level of statistical significance was 5% (p <0.05).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LDL-c equal or higher than 130mg/dL fasting lipemia.

Exclusion criteria

  • patients requiring reduction in daily fluid intake
  • patients in use of dietary fiber supplements
  • gestation
  • lactation

Treatment and study plan

oat bran - 40g

Dietary Supplement

oat bran - 40g per day

refined rice flour- 40g

Dietary Supplement

refined rice flour - 40g per day

Primary outcomes

  1. Change from baseline in LDL-cholesterol in three months

    Time frame: mesures assessed in baseline, after 30, 60 and 90 days

Secondary outcomes

  1. Change from baseline in glucose profile in three months

    Time frame: mesures assessed in baseline, after 30, 60 and 90 days

Other outcomes

  1. Change from baseline in body mass

    Time frame: mesures in kg, assessed in baseline, after 30, 60 and 90 days

  2. Change from baseline in waist circumference

    Time frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days

  3. Change from baseline in neck circumference

    Time frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

Effect of Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects in Secondary Prevention

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 14, 2014
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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