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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milled seed mix | Dietary Supplement | Dietary intervention with or without seed mix |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zorica Cvetkovic, MD PhD | Contact | +381641302624 | zokabora@yahoo.com | |
| Snjezana Petrovic, PhD | Contact | +381113031997 |
| Name | Affiliation | Role |
|---|---|---|
| Vesna Vucic, PhD | Institute for medical research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade | Recruiting | Belgrade | 11129 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28107691 | Background | 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. | |
| 20127484 | 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. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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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.
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Single blind
| 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 |
| 24578648 | 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. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |