Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma (Lymphoseed)

University of Belgrade

Status: Unknown

Conditions: Non-hodgkin Lymphoma

Treatments: Dietary Supplement: Milled seed mix

Study type: Interventional

Funder types: Other

Identifiers

NCT03260231

145/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Milled seed mix

Control group

No Intervention group

Description:

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.