<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02189200</url>
  </required_header>
  <id_info>
    <org_study_id>03131712.3.0000.5265</org_study_id>
    <nct_id>NCT02189200</nct_id>
  </id_info>
  <brief_title>Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects</brief_title>
  <official_title>Effect of Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects in Secondary Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic&#xD;
      and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse&#xD;
      events with statins, added to recent questions about their benefits on hard outcomes, opens a&#xD;
      gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in&#xD;
      patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary&#xD;
      fibers with supposed action in reducing the absorption of exogenous cholesterol and the&#xD;
      endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with&#xD;
      alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of&#xD;
      atherosclerotic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To evaluate the effect of nutritional counseling associated with the consumption&#xD;
      of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric&#xD;
      parameters of subjects in secondary prevention, evaluate the quality of the diet and the&#xD;
      intake of processed foods and ingredients added.&#xD;
&#xD;
      Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days.&#xD;
      Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or&#xD;
      higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral&#xD;
      lipid-lowering, since the dose reported in the early nutritional intervention was maintained&#xD;
      during the study. Exclusion criteria: patients requiring reduction in daily fluid intake,&#xD;
      supplement use in dietary fiber and gestation / lactation. Data collected: gender; age;&#xD;
      education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC),&#xD;
      neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C,&#xD;
      HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS),&#xD;
      HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the&#xD;
      Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot&#xD;
      study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo&#xD;
      group (GPL). The level of statistical significance was 5% (p &lt;0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in LDL-cholesterol in three months</measure>
    <time_frame>mesures assessed in baseline, after 30, 60 and 90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in glucose profile in three months</measure>
    <time_frame>mesures assessed in baseline, after 30, 60 and 90 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in body mass</measure>
    <time_frame>mesures in kg, assessed in baseline, after 30, 60 and 90 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in waist circumference</measure>
    <time_frame>mesures in cm, assessed in baseline, after 30, 60 and 90 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in neck circumference</measure>
    <time_frame>mesures in cm, assessed in baseline, after 30, 60 and 90 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Dietary Modification</condition>
  <arm_group>
    <arm_group_label>Oat bran group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oat bran (40g per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>refined rice flour (40g per day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>oat bran - 40g</intervention_name>
    <description>oat bran - 40g per day</description>
    <arm_group_label>Oat bran group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>refined rice flour- 40g</intervention_name>
    <description>refined rice flour - 40g per day</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LDL-c equal or higher than 130mg/dL fasting lipemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients requiring reduction in daily fluid intake&#xD;
&#xD;
          -  patients in use of dietary fiber supplements&#xD;
&#xD;
          -  gestation&#xD;
&#xD;
          -  lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simone R. Souza</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Estadual de Cardiologia Aloysio de Castro - IECAC</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22261-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://apps.who.int/iris/bitstream/10665/43235/1/9241593253_eng.pdf?ua=1</url>
    <description>WORLD HEALTH ORGANIZATION. Cardiovascular disease prevention and control. Translating evidence into action, 2005</description>
  </link>
  <link>
    <url>http://whqlibdoc.who.int/publications/2007/9789241547178_eng.pdf?ua=1</url>
    <description>WORLD HEALTH ORGANIZATION. Prevention of cardiovascular disease: guidelines for assessment and management of total cardiovascular risk, 2007</description>
  </link>
  <reference>
    <citation>Adamsson V, Reumark A, Marklund M, Larsson A, Riserus 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.</citation>
    <PMID>24814382</PMID>
  </reference>
  <reference>
    <citation>Andersson KE, Hellstrand P. Dietary oats and modulation of atherogenic pathways. Mol Nutr Food Res. 2012 Jul;56(7):1003-13. doi: 10.1002/mnfr.201100706. Epub 2012 Jun 12.</citation>
    <PMID>22764134</PMID>
  </reference>
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    <citation>Bentzon JF, Otsuka F, Virmani R, Falk E. Mechanisms of plaque formation and rupture. Circ Res. 2014 Jun 6;114(12):1852-66. doi: 10.1161/CIRCRESAHA.114.302721.</citation>
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    <citation>Briel M, Vale N, Schwartz GG, de Lemos JA, Colivicchi F, den Hartog FR, Ostadal P, Macin SM, Liem A, Mills E, Bhatnagar N, Bucher HC, Nordmann AJ. Updated evidence on early statin therapy for acute coronary syndromes: meta-analysis of 18 randomized trials involving over 14,000 patients. Int J Cardiol. 2012 Jun 28;158(1):93-100. doi: 10.1016/j.ijcard.2011.01.033. Epub 2011 Feb 4.</citation>
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    <citation>Camargo A, Meneses ME, Perez-Martinez P, Delgado-Lista J, Jimenez-Gomez Y, Cruz-Teno C, Tinahones FJ, Paniagua JA, Perez-Jimenez F, Roche HM, Malagon MM, Lopez-Miranda J. Dietary fat differentially influences the lipids storage on the adipose tissue in metabolic syndrome patients. Eur J Nutr. 2014;53(2):617-26. doi: 10.1007/s00394-013-0570-2. Epub 2013 Aug 7.</citation>
    <PMID>23922010</PMID>
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    <citation>Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thorne R, Beck E, Tosh SM. Effect of 6 weeks' consumption of beta-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.</citation>
    <PMID>21810288</PMID>
  </reference>
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    <citation>Chen CY, Milbury PE, Kwak HK, Collins FW, Samuel P, Blumberg JB. Avenanthramides and phenolic acids from oats are bioavailable and act synergistically with vitamin C to enhance hamster and human LDL resistance to oxidation. J Nutr. 2004 Jun;134(6):1459-66. doi: 10.1093/jn/134.6.1459.</citation>
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    <PMID>24814322</PMID>
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    <citation>Kalantarian S, Rimm EB, Herrington DM, Mozaffarian D. Dietary macronutrients, genetic variation, and progression of coronary atherosclerosis among women. Am Heart J. 2014 Apr;167(4):627-635.e1. doi: 10.1016/j.ahj.2014.01.001. Epub 2014 Jan 15.</citation>
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    <citation>Keaney JF Jr. Immune modulation of atherosclerosis. Circulation. 2011 Nov 29;124(22):e559-60. doi: 10.1161/CIRCULATIONAHA.111.074096. No abstract available.</citation>
    <PMID>22125193</PMID>
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    <citation>Lee DS, Markwardt S, Goeres L, Lee CG, Eckstrom E, Williams C, Fu R, Orwoll E, Cawthon PM, Stefanick ML, Mackey D, Bauer DC, Nielson CM. Statins and physical activity in older men: the osteoporotic fractures in men study. JAMA Intern Med. 2014 Aug;174(8):1263-70. doi: 10.1001/jamainternmed.2014.2266.</citation>
    <PMID>24911216</PMID>
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    <citation>Maki KC, Beiseigel JM, Jonnalagadda SS, Gugger CK, Reeves MS, Farmer MV, Kaden VN, Rains TM. Whole-grain ready-to-eat oat cereal, as part of a dietary program for weight loss, reduces low-density lipoprotein cholesterol in adults with overweight and obesity more than a dietary program including low-fiber control foods. J Am Diet Assoc. 2010 Feb;110(2):205-14. doi: 10.1016/j.jada.2009.10.037.</citation>
    <PMID>20102847</PMID>
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    <citation>Nie L, Wise ML, Peterson DM, Meydani M. Avenanthramide, a polyphenol from oats, inhibits vascular smooth muscle cell proliferation and enhances nitric oxide production. Atherosclerosis. 2006 Jun;186(2):260-6. doi: 10.1016/j.atherosclerosis.2005.07.027. Epub 2005 Sep 1.</citation>
    <PMID>16139284</PMID>
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  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Simone Raimondi de Souza</investigator_full_name>
    <investigator_title>Dra.</investigator_title>
  </responsible_party>
  <keyword>nutritional counseling</keyword>
  <keyword>oat bran</keyword>
  <keyword>dyslipidemia</keyword>
  <keyword>cardiovascular disease</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02189200
org study id: 03131712.3.0000.5265
nct id: NCT02189200
lead sponsor: 
has dmc: Yes
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in LDL-cholesterol in three months
time frame: mesures assessed in baseline, after 30, 60 and 90 days
measure: Change from baseline in glucose profile in three months
time frame: mesures assessed in baseline, after 30, 60 and 90 days
measure: Change from baseline in body mass
time frame: mesures in kg, assessed in baseline, after 30, 60 and 90 days
measure: Change from baseline in waist circumference
time frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days
measure: Change from baseline in neck circumference
time frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days
arm group label: Oat bran group
arm group type: Active Comparator
description: oat bran (40g per day)
arm group label: Placebo group
arm group type: Placebo Comparator
description: refined rice flour (40g per day)
intervention type: Dietary Supplement
intervention name: oat bran - 40g
description: oat bran - 40g per day
arm group label: Oat bran group
intervention type: Dietary Supplement
intervention name: refined rice flour- 40g
description: refined rice flour - 40g per day
arm group label: Placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Simone R. Souza
role: Principal Investigator
affiliation: Universidade Federal do Rio de Janeiro
facility: 
country: Brazil
url: http://apps.who.int/iris/bitstream/10665/43235/1/9241593253_eng.pdf?ua=1
description: WORLD HEALTH ORGANIZATION. Cardiovascular disease prevention and control. Translating evidence into action, 2005
url: http://whqlibdoc.who.int/publications/2007/9789241547178_eng.pdf?ua=1
description: WORLD HEALTH ORGANIZATION. Prevention of cardiovascular disease: guidelines for assessment and management of total cardiovascular risk, 2007
citation: Adamsson V, Reumark A, Marklund M, Larsson A, Riserus 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.
PMID: 24814382
citation: Andersson KE, Hellstrand P. Dietary oats and modulation of atherogenic pathways. Mol Nutr Food Res. 2012 Jul;56(7):1003-13. doi: 10.1002/mnfr.201100706. Epub 2012 Jun 12.
PMID: 22764134
citation: Bentzon JF, Otsuka F, Virmani R, Falk E. Mechanisms of plaque formation and rupture. Circ Res. 2014 Jun 6;114(12):1852-66. doi: 10.1161/CIRCRESAHA.114.302721.
PMID: 24902970
citation: Briel M, Vale N, Schwartz GG, de Lemos JA, Colivicchi F, den Hartog FR, Ostadal P, Macin SM, Liem A, Mills E, Bhatnagar N, Bucher HC, Nordmann AJ. Updated evidence on early statin therapy for acute coronary syndromes: meta-analysis of 18 randomized trials involving over 14,000 patients. Int J Cardiol. 2012 Jun 28;158(1):93-100. doi: 10.1016/j.ijcard.2011.01.033. Epub 2011 Feb 4.
PMID: 21295870
citation: Sadiq Butt M, Tahir-Nadeem M, Khan MK, Shabir R, Butt MS. Oat: unique among the cereals. Eur J Nutr. 2008 Mar;47(2):68-79. doi: 10.1007/s00394-008-0698-7. Epub 2008 Feb 26.
PMID: 18301937
citation: Camargo A, Meneses ME, Perez-Martinez P, Delgado-Lista J, Jimenez-Gomez Y, Cruz-Teno C, Tinahones FJ, Paniagua JA, Perez-Jimenez F, Roche HM, Malagon MM, Lopez-Miranda J. Dietary fat differentially influences the lipids storage on the adipose tissue in metabolic syndrome patients. Eur J Nutr. 2014;53(2):617-26. doi: 10.1007/s00394-013-0570-2. Epub 2013 Aug 7.
PMID: 23922010
citation: Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thorne R, Beck E, Tosh SM. Effect of 6 weeks' consumption of beta-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.
PMID: 21810288
citation: Chen CY, Milbury PE, Kwak HK, Collins FW, Samuel P, Blumberg JB. Avenanthramides and phenolic acids from oats are bioavailable and act synergistically with vitamin C to enhance hamster and human LDL resistance to oxidation. J Nutr. 2004 Jun;134(6):1459-66. doi: 10.1093/jn/134.6.1459.
PMID: 15173412
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responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Simone Raimondi de Souza
investigator title: Dra.