Effects of Dietary Milled Seed Mix in Patients With Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in disease status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Single blind
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Non-Hodgkin lymphoma
- •Patients able to understand requirements of the study and provide written informed consent
排除标准
- •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
研究组 & 干预措施
Intervention group
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.
干预措施: Milled seed mix (Dietary Supplement)
Control group
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.
结局指标
主要结局
Change in disease status
时间窗: Baseline, 5 months, 1 year
Remission, stable disease or progression
Change in quality of life questionnaire scores
时间窗: Baseline, 5 months, 1 year
Assessed by standardized questionnaires
次要结局
- Changes in plasma fatty acids(Baseline, 5 months, 1 year)
- Changes in interleukin (IL)-6(Baseline, 5 months, 1 year)
- Changes in leukocyte count(Baseline, 5 months, 1 year)
- Changes in lipid profiles(Baseline, 5 months, 1 year)
- Changes in body weight(Baseline, 5 months, 1 year)
- Changes in CRP(Baseline, 5 months, 1 year)
- Changes in parameters of oxidative stress(Baseline, 5 months)
研究者
Vesna Vucic
Professor of Research
University of Belgrade