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

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ClinicalTrials.gov Identifier: NCT02189200
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Simone Raimondi de Souza, Universidade Federal do Rio de Janeiro

Tracking Information
First Submitted Date  ICMJE July 7, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)		 Change from baseline in LDL-cholesterol in three months [ Time Frame: mesures assessed in baseline, after 30, 60 and 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)		 Change from baseline in glucose profile in three months [ Time Frame: mesures assessed in baseline, after 30, 60 and 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
  • Change from baseline in body mass [ Time Frame: mesures in kg, assessed in baseline, after 30, 60 and 90 days ]
  • Change from baseline in waist circumference [ Time Frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days ]
  • Change from baseline in neck circumference [ Time Frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects
Official Title  ICMJE Effect of Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects in Secondary Prevention
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dietary Modification
Intervention  ICMJE
  • Dietary Supplement: oat bran - 40g
    oat bran - 40g per day
  • Dietary Supplement: refined rice flour- 40g
    refined rice flour - 40g per day
Study Arms  ICMJE
  • Active Comparator: Oat bran group
    oat bran (40g per day)
    Intervention: Dietary Supplement: oat bran - 40g
  • Placebo Comparator: Placebo group
    refined rice flour (40g per day)
    Intervention: Dietary Supplement: refined rice flour- 40g
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)		 132
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189200
Other Study ID Numbers  ICMJE 03131712.3.0000.5265
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Simone Raimondi de Souza, Universidade Federal do Rio de Janeiro
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simone R. Souza Universidade Federal do Rio de Janeiro
PRS Account Universidade Federal do Rio de Janeiro
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP