Can a Daily Consuming of Opuntia (Tzabar Fruit) Reduce Symptoms of Fatigue, Pain and Depression Among Women With Fibromyalgia
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
- 否
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
Orli Grinstein-Cohen PhD
Head of the Nursing Department Ben Gurion University
Soroka University Medical Center
