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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Dietary Modification Dietary Supplement: oat bran - 40g Dietary Supplement: refined rice flour- 40g Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects in Secondary Prevention
Study Start Date : October 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Active Comparator: Oat bran group
oat bran (40g per day)
Dietary Supplement: oat bran - 40g
oat bran - 40g per day

Placebo Comparator: Placebo group
refined rice flour (40g per day)
Dietary Supplement: refined rice flour- 40g
refined rice flour - 40g per day




Primary Outcome Measures :
  1. Change from baseline in LDL-cholesterol in three months [ Time Frame: mesures assessed in baseline, after 30, 60 and 90 days ]

Secondary Outcome Measures :
  1. Change from baseline in glucose profile in three months [ Time Frame: mesures assessed in baseline, after 30, 60 and 90 days ]

Other Outcome Measures:
  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 ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189200


Locations
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Brazil
Instituto Estadual de Cardiologia Aloysio de Castro - IECAC
Rio de Janeiro, Brazil, 22261-010
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Principal Investigator: Simone R. Souza Universidade Federal do Rio de Janeiro
Additional Information:
Publications:

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Responsible Party: Simone Raimondi de Souza, Dra., Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02189200    
Other Study ID Numbers: 03131712.3.0000.5265
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Simone Raimondi de Souza, Universidade Federal do Rio de Janeiro:
nutritional counseling
oat bran
dyslipidemia
cardiovascular disease