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Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma (Lymphoseed)

Primary Purpose

Non-hodgkin Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Milled seed mix
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-hodgkin Lymphoma

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed Non-Hodgkin lymphoma
  • Patients able to understand requirements of the study and provide written informed consent

Exclusion Criteria:

  • Previous radio- or chemotherapy
  • Other serious chronic diseases
  • Statin therapy
  • Presence of allergy on any seeds
  • Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study

Sites / Locations

  • Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of BelgradeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in disease status
Remission, stable disease or progression
Change in quality of life questionnaire scores
Assessed by standardized questionnaires

Secondary Outcome Measures

Changes in body weight
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Changes in leukocyte count
Measures of leukocyte count
Changes in lipid profiles
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Changes in plasma fatty acids
Changes in plasma fatty acids profiles from baseline to endpoint
Changes in CRP
Changes in CRP from baseline to endpoint
Changes in interleukin (IL)-6
Changes in interleukin (IL)-6 from baseline to endpoint
Changes in parameters of oxidative stress
Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase

Full Information

First Posted
August 11, 2017
Last Updated
March 19, 2020
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT03260231
Brief Title
Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
Acronym
Lymphoseed
Official Title
Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderInvestigator
Masking Description
Single blind
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm 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 Title
Control group
Arm Type
No Intervention
Arm 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(s)
Milled seed mix
Intervention Description
Dietary intervention with or without seed mix
Primary Outcome Measure Information:
Title
Change in disease status
Description
Remission, stable disease or progression
Time Frame
Baseline, 5 months, 1 year
Title
Change in quality of life questionnaire scores
Description
Assessed by standardized questionnaires
Time Frame
Baseline, 5 months, 1 year
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Time Frame
Baseline, 5 months, 1 year
Title
Changes in leukocyte count
Description
Measures of leukocyte count
Time Frame
Baseline, 5 months, 1 year
Title
Changes in lipid profiles
Description
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Time Frame
Baseline, 5 months, 1 year
Title
Changes in plasma fatty acids
Description
Changes in plasma fatty acids profiles from baseline to endpoint
Time Frame
Baseline, 5 months, 1 year
Title
Changes in CRP
Description
Changes in CRP from baseline to endpoint
Time Frame
Baseline, 5 months, 1 year
Title
Changes in interleukin (IL)-6
Description
Changes in interleukin (IL)-6 from baseline to endpoint
Time Frame
Baseline, 5 months, 1 year
Title
Changes in parameters of oxidative stress
Description
Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase
Time Frame
Baseline, 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed Non-Hodgkin lymphoma Patients able to understand requirements of the study and provide written informed consent Exclusion Criteria: Previous radio- or chemotherapy Other serious chronic diseases Statin therapy Presence of allergy on any seeds Use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zorica Cvetkovic, MD PhD
Phone
+381641302624
Email
zokabora@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Snjezana Petrovic, PhD
Phone
+381113031997
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vesna Vucic, PhD
Organizational Affiliation
Institute for medical research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
City
Belgrade
ZIP/Postal Code
11129
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vesna Vucic, PhD
Phone
+381113031997
Email
vesna.vucic.imr@gmail.com
First Name & Middle Initial & Last Name & Degree
Danijela Ristic Medic, MD PhD
First Name & Middle Initial & Last Name & Degree
Vesna Vucic, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28107691
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.
Results Reference
background
PubMed Identifier
20127484
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.
Results Reference
background
PubMed Identifier
24578648
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.
Results Reference
background

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Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

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