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

March 19, 2020 updated by: Vesna Vucic, University of Belgrade

Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11129
        • Recruiting
        • Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
        • Contact:
        • Contact:
          • Danijela Ristic Medic, MD PhD
        • Principal Investigator:
          • Vesna Vucic, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group
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.
Dietary supplement: Milled seed mix
Dietary intervention with or without seed mix
NO_INTERVENTION: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disease status
Time Frame: Baseline, 5 months, 1 year
Remission, stable disease or progression
Baseline, 5 months, 1 year
Change in quality of life questionnaire scores
Time Frame: Baseline, 5 months, 1 year
Assessed by standardized questionnaires
Baseline, 5 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body weight
Time Frame: Baseline, 5 months, 1 year
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint
Baseline, 5 months, 1 year
Changes in leukocyte count
Time Frame: Baseline, 5 months, 1 year
Measures of leukocyte count
Baseline, 5 months, 1 year
Changes in lipid profiles
Time Frame: Baseline, 5 months, 1 year
Changes in lipid profiles (cholesterol, HDL, LDL and triglycerides) from baseline to endpoint
Baseline, 5 months, 1 year
Changes in plasma fatty acids
Time Frame: Baseline, 5 months, 1 year
Changes in plasma fatty acids profiles from baseline to endpoint
Baseline, 5 months, 1 year
Changes in CRP
Time Frame: Baseline, 5 months, 1 year
Changes in CRP from baseline to endpoint
Baseline, 5 months, 1 year
Changes in interleukin (IL)-6
Time Frame: Baseline, 5 months, 1 year
Changes in interleukin (IL)-6 from baseline to endpoint
Baseline, 5 months, 1 year
Changes in parameters of oxidative stress
Time Frame: Baseline, 5 months
Measures of activities of the following enzymes: SOD, catalase, glutathion peroxidase and glutation reductase
Baseline, 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Vesna Vucic, PhD, Institute for Medical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 12, 2017

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (ACTUAL)

August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 145/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-hodgkin Lymphoma

Clinical Trials on Milled seed mix

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe