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临床试验/NCT05230602
NCT05230602进行中(未招募)不适用

Can a Daily Consuming of Opuntia (Tzabar Fruit) Reduce Symptoms of Fatigue, Pain and Depression Among Women With Fibromyalgia

Soroka University Medical Center2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
19
试验地点
2
主要终点
consumption of tzabar fruit has a positive influence on the reduction of pain

研究概览

简要总结

To examine whether the addition of tzabar fruit twice a day to a routine daily nutrition regime will:

A- Reduce symptoms of fatigue, pain and depression in FM patients

B. Have positive influence on quality of life

详细描述

Project description Fibromyalgia (FM) is a chronic and idiopathic syndrome, characterized by a general distributed pain, more prevalent in women. Alongside with musculoskeletal pain, symptoms of fatigue, depression, anxiety and cognitive dysfunction are reported by the patients .The underlying pathophysiology of FM is still poorly understood, and treatment is often unsatisfactory. Current research provides evidence for altered pain processing in chronic pain patients, and specifically in FM patients.

Treatment for this syndrome is challenging and focuses on alleviation of symptoms. Patients use prescribed medication together with different complementary and alternative medicine treatments. Yet, the lack of adherence to the established treatment is quite common. Some patients do not conform to prescribed medication and reduce the recommended dose or interrupt the treatment whereas others use overdoses and self-medication. It is important to note that the patient's quality of life was higher in patients with higher adherence to treatment and persistence. Due to the lack of specific and standardized treatments for the management of FM, available evidence suggests a multidisciplinary approach, and nutrition represents an important therapeutic strategy.

The rationale for the current study is based on the platform of other chronic disease and the beneficial effect of consuming opuntia fruits (tzabar). The investigators propose a change in diet to reduce fatigue and chronic pain.

The mechanism explaining the benefits of opuntia fruit-tzabar, are not fully clear. Yet, several proposed pathways are suggested in the literature. The effect of tzabar was studied in in vitro model by Nunes et al. (2011) using intestinal cells taken from patients with Crohn and Colitis. Nunes et al. (2011) found that tzabar extract reduced pro-inflammatory mediators' secretion of IL-8. The reduction of IL-8 was explained via the reduction of NFkB pathway activation. This pathway inhibits the nuclear translocation of the redox sensitive transcription factor NFkB. Another possible mechanism for alleviation of pain symptoms is the high percentages of polysaccharides that tzabar fruits contain. High levels of polysaccharides were related to inhibition of alpha glucosidase inhibitor through a barrier function. Furthermore, tzabar has high level of fibers such as pectin which are beneficial to a healthy diet regime.

The investigators will examine whether an addition of tzabar twice a day to a daily nutrition regime will reduce the symptoms of fatigue and pain among patients with FM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women diagnosed with FM
  • Age over 18
  • Fluent in Hebrew

排除标准

  • sensitivity to tzabar/exotic fruits
  • Suffer from digestive issues, such as irritable bowel syndrome
  • Participating in another interventional study
  • Removal criteria
  • Participants who do not complete the study follow-up period.

结局指标

主要结局

consumption of tzabar fruit has a positive influence on the reduction of pain

时间窗: Two weeks

Pain will be measured using the Widespread Pain Index (WPI) higher scores indicate greater widespread pain

consumption of tzabar fruit has a positive influence on depressive symptoms

时间窗: Two weeks

Depression will be assessed by Beck Depression Inventory (Beck, 1996). higher scores indicate severe depressive symptoms.Those that will be detected with depression will be refer back to the outpatient clinic for advice and treatment

consumption of tzabar fruit has a positive influence on fatigue

时间窗: Two weeks

fatigue will be measured using the Symptom Severity Scale (SSS) (Wolfe et al.,2010). higher scores indicate severe Symptoms including fatigue

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Orli Grinstein-Cohen PhD

Head of the Nursing Department Ben Gurion University

Soroka University Medical Center

研究点 (2)

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