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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02189200
Enrollment
132
Registered
2014-07-14
Start date
2012-10-31
Completion date
2014-04-30
Last updated
2016-05-12

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

Conditions

Dietary Modification

Keywords

nutritional counseling, oat bran, dyslipidemia, cardiovascular disease

Brief summary

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.

Detailed description

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).

Interventions

DIETARY_SUPPLEMENToat bran - 40g

oat bran - 40g per day

DIETARY_SUPPLEMENTrefined rice flour- 40g

refined rice flour - 40g per day

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in LDL-cholesterol in three monthsmesures assessed in baseline, after 30, 60 and 90 days

Secondary

MeasureTime frame
Change from baseline in glucose profile in three monthsmesures assessed in baseline, after 30, 60 and 90 days

Other

MeasureTime frame
Change from baseline in body massmesures in kg, assessed in baseline, after 30, 60 and 90 days
Change from baseline in waist circumferencemesures in cm, assessed in baseline, after 30, 60 and 90 days
Change from baseline in neck circumferencemesures in cm, assessed in baseline, after 30, 60 and 90 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026