<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/NCT03260231</url>
  </required_header>
  <id_info>
    <org_study_id>145/1</org_study_id>
    <nct_id>NCT03260231</nct_id>
  </id_info>
  <brief_title>Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma</brief_title>
  <acronym>Lymphoseed</acronym>
  <official_title>Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Belgrade</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Belgrade</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent literature data suggest beneficial effects of dietary fats in patients with cancers,&#xD;
      in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin&#xD;
      seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancers are characterized by inflammation and alternations in lipid and fatty acid&#xD;
      metabolism. Patients with non-Hodgkin lymphoma have impaired fatty acid profiles, low level&#xD;
      of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical&#xD;
      outcome.&#xD;
&#xD;
      Flax seeds, sesame and pumpkin seeds are rich sources of PUFAs. Dietary intake of milled mix&#xD;
      of these seeds has been shown to decrease inflammation and improve PUFAs status in patients&#xD;
      on hemodialysis and to decrease breast cancer risk.&#xD;
&#xD;
      The study design is single-blind, controlled, randomized nutritional intervention. The&#xD;
      participants are randomly assigned into intervention and control group before starting&#xD;
      chemotherapy. All patients receive nutritional counseling to achieve a daily energy and&#xD;
      protein intake according to recommended dietary allowances, with (intervention) or without&#xD;
      (control) of milled seed mix.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 12, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>
    <intervention_model_description>This study is a parallel, randomized, single blind, controlled, 5-months nutritional intervention, investigating health effects of dietary intake of milled mix of flax/sesame pumpkin seeds in sour milk, in patients with NHL undergoing chemotherapy.&#xD;
At the beginning of the study, all patients received nutritional counselling, where half of the study subjects are randomly assigned to a treatment arm with milled seed mix consumption, or control arm without seed mix. Treatment arm is provided with 450g of milled seed mix and instructed to consume 30g of the mix daily (18g flax seed, 6g pumpkin seeds, and 6 g sesame) in 180 mL of sour milk. Control arm is instructed to consume180 mL of sour milk.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>Single blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in disease status</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Remission, stable disease or progression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life questionnaire scores</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Assessed by standardized questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leukocyte count</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Measures of leukocyte count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lipid profiles</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in plasma fatty acids</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Changes in plasma fatty acids profiles from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CRP</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Changes in CRP from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in interleukin (IL)-6</measure>
    <time_frame>Baseline, 5 months, 1 year</time_frame>
    <description>Changes in interleukin (IL)-6 from baseline to endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in parameters of oxidative stress</measure>
    <time_frame>Baseline, 5 months</time_frame>
    <description>Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Non-hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dietary Supplement: Milled Seed Mix Intervention arm includes milled mix of flax, sesame and pumpkin seeds (18/6/6 g) in sour milk taken as dietary replacement meal during the day, and between lunch and dinner. Seeds are provided with the same producer at the Belgrade market.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No supplement Control arm includes nutritional counseling with a similar dietary regime as for the intervention arm, but without milled seed mix. patients were instructed to avoid plant seeds during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Milled seed mix</intervention_name>
    <description>Dietary intervention with or without seed mix</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed Non-Hodgkin lymphoma&#xD;
&#xD;
          -  Patients able to understand requirements of the study and provide written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous radio- or chemotherapy&#xD;
&#xD;
          -  Other serious chronic diseases&#xD;
&#xD;
          -  Statin therapy&#xD;
&#xD;
          -  Presence of allergy on any seeds&#xD;
&#xD;
          -  Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3&#xD;
             months prior to study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vesna Vucic, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for medical research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zorica Cvetkovic, MD PhD</last_name>
    <phone>+381641302624</phone>
    <email>zokabora@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Snjezana Petrovic, PhD</last_name>
    <phone>+381113031997</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade</name>
      <address>
        <city>Belgrade</city>
        <zip>11129</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vesna Vucic, PhD</last_name>
      <phone>+381113031997</phone>
      <email>vesna.vucic.imr@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Danijela Ristic Medic, MD PhD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Vesna Vucic, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <reference>
    <citation>Cvetkovic Z, Milosevic M, Cvetkovic B, Masnikosa R, Arsic A, Petrovic S, Vucic V. Plasma phospholipid changes are associated with response to chemotherapy in non-Hodgkin lymphoma patients. Leuk Res. 2017 Mar;54:39-46. doi: 10.1016/j.leukres.2017.01.004. Epub 2017 Jan 5.</citation>
    <PMID>28107691</PMID>
  </reference>
  <reference>
    <citation>Cvetkovic Z, Vucic V, Cvetkovic B, Petrovic M, Ristic-Medic D, Tepsic J, Glibetic M. Abnormal fatty acid distribution of the serum phospholipids of patients with non-Hodgkin lymphoma. Ann Hematol. 2010 Aug;89(8):775-82. doi: 10.1007/s00277-010-0904-6. Epub 2010 Feb 3.</citation>
    <PMID>20127484</PMID>
  </reference>
  <reference>
    <citation>Ristic-Medic D, Perunicic-Pekovic G, Rasic-Milutinovic Z, Takic M, Popovic T, Arsic A, Glibetic M. Effects of dietary milled seed mixture on fatty acid status and inflammatory markers in patients on hemodialysis. ScientificWorldJournal. 2014 Jan 22;2014:563576. doi: 10.1155/2014/563576. eCollection 2014.</citation>
    <PMID>24578648</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Belgrade</investigator_affiliation>
    <investigator_full_name>Vesna Vucic</investigator_full_name>
    <investigator_title>Professor of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03260231
org study id: 145/1
nct id: NCT03260231
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Recent literature data suggest beneficial effects of dietary fats in patients with cancers,
      in particular polyunsaturated fatty acids (PUFAs). Milled mix of flax, sesame and pumpkin
      seeds provides a high amount of PUFAs and a desirable n-6/n-3 PUFAs ratio.
Cancers are characterized by inflammation and alternations in lipid and fatty acid
      metabolism. Patients with non-Hodgkin lymphoma have impaired fatty acid profiles, low level
      of PUFAs, and high n-6/n-3 PUFAs ratio. Moreover, these changes are related to clinical
      outcome.

      Flax seeds, sesame and pumpkin seeds are rich sources of PUFAs. Dietary intake of milled mix
      of these seeds has been shown to decrease inflammation and improve PUFAs status in patients
      on hemodialysis and to decrease breast cancer risk.

      The study design is single-blind, controlled, randomized nutritional intervention. The
      participants are randomly assigned into intervention and control group before starting
      chemotherapy. All patients receive nutritional counseling to achieve a daily energy and
      protein intake according to recommended dietary allowances, with (intervention) or without
      (control) of milled seed mix.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a parallel, randomized, single blind, controlled, 5-months nutritional intervention, investigating health effects of dietary intake of milled mix of flax/sesame pumpkin seeds in sour milk, in patients with NHL undergoing chemotherapy.
At the beginning of the study, all patients received nutritional counselling, where half of the study subjects are randomly assigned to a treatment arm with milled seed mix consumption, or control arm without seed mix. Treatment arm is provided with 450g of milled seed mix and instructed to consume 30g of the mix daily (18g flax seed, 6g pumpkin seeds, and 6 g sesame) in 180 mL of sour milk. Control arm is instructed to consume180 mL of sour milk.
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
masking description: Single blind
measure: Change in disease status
time frame: Baseline, 5 months, 1 year
description: Remission, stable disease or progression
measure: Change in quality of life questionnaire scores
time frame: Baseline, 5 months, 1 year
description: Assessed by standardized questionnaires
measure: Changes in body weight
time frame: Baseline, 5 months, 1 year
description: Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
measure: Changes in leukocyte count
time frame: Baseline, 5 months, 1 year
description: Measures of leukocyte count
measure: Changes in lipid profiles
time frame: Baseline, 5 months, 1 year
description: Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
measure: Changes in plasma fatty acids
time frame: Baseline, 5 months, 1 year
description: Changes in plasma fatty acids profiles from baseline to endpoint
measure: Changes in CRP
time frame: Baseline, 5 months, 1 year
description: Changes in CRP from baseline to endpoint
measure: Changes in interleukin (IL)-6
time frame: Baseline, 5 months, 1 year
description: Changes in interleukin (IL)-6 from baseline to endpoint
measure: Changes in parameters of oxidative stress
time frame: Baseline, 5 months
description: Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase
arm group label: Intervention group
arm group type: Active Comparator
description: Dietary Supplement: Milled Seed Mix Intervention arm includes milled mix of flax, sesame and pumpkin seeds (18/6/6 g) in sour milk taken as dietary replacement meal during the day, and between lunch and dinner. Seeds are provided with the same producer at the Belgrade market.
arm group label: Control group
arm group type: No Intervention
description: No supplement Control arm includes nutritional counseling with a similar dietary regime as for the intervention arm, but without milled seed mix. patients were instructed to avoid plant seeds during the study.
intervention type: Dietary Supplement
intervention name: Milled seed mix
description: Dietary intervention with or without seed mix
arm group label: Intervention group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Vesna Vucic, PhD
role: Principal Investigator
affiliation: Institute for medical research
last name: Zorica Cvetkovic, MD PhD
phone: +381641302624
email: zokabora@yahoo.com
last name: Snjezana Petrovic, PhD
phone: +381113031997
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Serbia
citation: Cvetkovic Z, Milosevic M, Cvetkovic B, Masnikosa R, Arsic A, Petrovic S, Vucic V. Plasma phospholipid changes are associated with response to chemotherapy in non-Hodgkin lymphoma patients. Leuk Res. 2017 Mar;54:39-46. doi: 10.1016/j.leukres.2017.01.004. Epub 2017 Jan 5.
PMID: 28107691
citation: Cvetkovic Z, Vucic V, Cvetkovic B, Petrovic M, Ristic-Medic D, Tepsic J, Glibetic M. Abnormal fatty acid distribution of the serum phospholipids of patients with non-Hodgkin lymphoma. Ann Hematol. 2010 Aug;89(8):775-82. doi: 10.1007/s00277-010-0904-6. Epub 2010 Feb 3.
PMID: 20127484
citation: Ristic-Medic D, Perunicic-Pekovic G, Rasic-Milutinovic Z, Takic M, Popovic T, Arsic A, Glibetic M. Effects of dietary milled seed mixture on fatty acid status and inflammatory markers in patients on hemodialysis. ScientificWorldJournal. 2014 Jan 22;2014:563576. doi: 10.1155/2014/563576. eCollection 2014.
PMID: 24578648
responsible party type: Principal Investigator
investigator affiliation: University of Belgrade
investigator full name: Vesna Vucic
investigator title: Professor of Research
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
sharing ipd: No