Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-hodgkin Lymphoma

Intervention / Treatment
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* Dietary Supplement: Milled seed mix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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<br>* Dietary intervention with or without seed mix<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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