Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

NCT03260231 | Unknown

• 1 other identifier: 145/1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Change in disease status

  Remission, stable disease or progression

  Baseline, 5 months, 1 year

• Change in quality of life questionnaire scores

  Assessed by standardized questionnaires

  Baseline, 5 months, 1 year

Secondary Outcomes (7)

• Changes in body weight

  Baseline, 5 months, 1 year

• Changes in leukocyte count

  Baseline, 5 months, 1 year

• Changes in lipid profiles

  Baseline, 5 months, 1 year

• Changes in plasma fatty acids

  Baseline, 5 months, 1 year

• Changes in CRP

  Baseline, 5 months, 1 year

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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.

Interventions

Milled seed mix DIETARY_SUPPLEMENT

Dietary intervention with or without seed mix

Intervention group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

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

Belgrade, 11129, Serbia

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Vesna Vucic, PhD

  Institute for medical research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zorica Cvetkovic, MD PhD

CONTACT

+381641302624; zokabora@yahoo.com

Snjezana Petrovic, PhD

CONTACT

+381113031997

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Research

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 24, 2017
• Study Start: May 12, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)