Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

Not Applicable

• Conditions: Non-hodgkin Lymphoma
• Interventions: Dietary Supplement: Milled seed mix

• Registration Number: NCT03260231
• Lead Sponsor: University of Belgrade

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.

Study Timeline

• Study Start: 2017-05-12
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Milled seed mix	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.

Primary Outcome Measures

Name	Time	Method
Change in disease status	Baseline, 5 months, 1 year	Remission, stable disease or progression
Change in quality of life questionnaire scores	Baseline, 5 months, 1 year	Assessed by standardized questionnaires

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade; 🇷🇸 Belgrade, Serbia