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

Dietary Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189200
• Other study ID #: 03131712.3.0000.5265
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: July 11, 2014
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Dietary Supplement:
• oat bran - 40g per day
oat bran - 40g per day

Locations

Country	Name	City	State
Brazil	Instituto Estadual de Cardiologia Aloysio de Castro - IECAC	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (25)

Adamsson V, Reumark A, Marklund M, Larsson A, Risérus U. Role of a prudent breakfast in improving cardiometabolic risk factors in subjects with hypercholesterolemia: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):20-6. doi: 10.1016/j.clnu.2014.04.009. Epub 2014 Apr 21. — View Citation

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Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thorne R, Beck E, Tosh SM. Effect of 6 weeks' consumption of ß-glucan-rich oat products on cholesterol levels in mildly hypercholesterolaemic overweight adults. Br J Nutr. 2012 Apr;107(7):1037-47. doi: 10.1017/S0007114511003850. Epub 2011 Aug 3. — View Citation

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Yang J, Ou B, Wise ML, Chu Y. In vitro total antioxidant capacity and anti-inflammatory activity of three common oat-derived avenanthramides. Food Chem. 2014 Oct 1;160:338-45. doi: 10.1016/j.foodchem.2014.03.059. Epub 2014 Mar 21. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in body mass		mesures in kg, assessed in baseline, after 30, 60 and 90 days	No
Other	Change from baseline in waist circumference		mesures in cm, assessed in baseline, after 30, 60 and 90 days	No
Other	Change from baseline in neck circumference		mesures in cm, assessed in baseline, after 30, 60 and 90 days	No
Primary	Change from baseline in LDL-cholesterol in three months		mesures assessed in baseline, after 30, 60 and 90 days	No
Secondary	Change from baseline in glucose profile in three months		mesures assessed in baseline, after 30, 60 and 90 days	No

External Links

•   WORLD HEALTH ORGANIZATION. Cardiovascular disease prevention and control. Translating evidence into action, 2005
•   WORLD HEALTH ORGANIZATION. Global Strategy on Diet, Physical Activity and Health, 2004
•   WORLD HEALTH ORGANIZATION. Prevention of cardiovascular disease: guidelines for assessment and management of total cardiovascular risk, 2007