Clinical trial NCT03260231: Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
Official title: Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-hodgkin Lymphoma
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Change in disease status
timeFrame: Baseline, 5 months, 1 year
measure: Change in quality of life questionnaire scores
timeFrame: Baseline, 5 months, 1 year
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline, 5 months, 1 year
measure: Changes in leukocyte count
timeFrame: Baseline, 5 months, 1 year
measure: Changes in lipid profiles
timeFrame: Baseline, 5 months, 1 year
measure: Changes in plasma fatty acids
timeFrame: Baseline, 5 months, 1 year
measure: Changes in CRP
timeFrame: Baseline, 5 months, 1 year
measure: Changes in interleukin (IL)-6
timeFrame: Baseline, 5 months, 1 year
measure: Changes in parameters of oxidative stress
timeFrame: Baseline, 5 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Study officials:
affiliation: Institute for medical research
name: Vesna Vucic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.