Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05230602 |
| Other study ID # |
0207-21-SOR |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
December 2022 |
| Source |
Soroka University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
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.
Aims
1. To examine whether the consumption of tzabar fruit has a positive influence on the
reduction of fatigue, pain and depressive symptoms among patients with FM.
2. To examine whether the consumption of tzabar fruit has a positive influence on quality
of life of patients with FM.
Hypotheses
1. The consumption of tzabar fruit twice a day for one month will reduce symptoms of a)
fatigue, b) pain and c) depression among patients with FM.
2. The consumption tzabar fruit twice a day for one month will have a beneficial influence
on the quality of life of FM patients.
Method Longitudinal study design. Inclusion criteria are women diagnosed with FM, age over
18, fluent in Hebrew. Non-inclusion criteria are FM patients with known sensitivity to
tzabar/exotic fruits, FM patients known to suffer from digestive issues, such as irritable
bowel syndrome, FM patients participating in another interventional study. Removal criteria
are participants who do not complete the study follow-up period. The patients will be
recruited from the rheumatological clinic at the Soroka Medical Center. Each patient arriving
at the clinic and answering the inclusion criteria will be invited to participate and will
sign an informed consent. The clinic operated once a week. Patients arriving on even dates
during the first month of the study will be entered to the study group whereas patients on
odd dates will comprise the control group.
The investigators performed calculations to estimate sample size. The investigators expected
a modest (2.9 points on a 10-point scale) reduction in pain, relative to control. Given
previously reported SDs of 3.5 on this scale in fibromyalgia, following Rasmussen et al.
(2012) the sample size needed to detect an effect of this size, with a two-tailed alpha of
0.05 and power of 0.80, was 15 per group.
Measurement Dependent variables (quality of life, anxiety, pain, fatigue, depression) will be
measured using the Widespread Pain Index (WPI), and the Symptom Severity Scale (SSS), along
with Hebrew version of the quality-of-life questionnaire SF-36. Depression will be assessed
by Beck Depression Inventory. Those that will be detected with depression will be refer back
to Dr. Zeler for advice and treatment. If needed the psychiatric ward will be informed to
build treatment program.
Process At the start of the study (T1), the participants will fill the above scales. The
participants will then be divided randomly into two equal groups. Group A will be instructed
to eat the tzabar fruit twice a day for two weeks, while Group B, the control group, will be
instructed not to change their diet. At the end of 14 days (T2) all participants will be
re-assessed again. Then Group B will be instructed to eat the tzabar fruit twice a day for 14
days, while Group A, will be instructed to eat their regular diet. During the research
period, the participants will be instructed to continue their regular treatment routine,
whether this includes taking medication, performing sporting activity, and so on in order to
avoid undesirable influences that could bias the research results. The tzabar fruits will be
supplied by the research team, in a neutral location. After a month all participants will
fill the above scales.
Statistical analysis of data The statistical analysis of the data will be conducted using
SPSS software. Descriptive statistics will be employed to characterize the sample. The data
will be presented as categorical, ordinal, or continuous variables. For categorical
variables, the number of participants and the percentage in each category will be presented.
Ordinal variables will be presented using the median and the frequent. Quantitative variables
will be presented using the average and standard deviation values. The changes in QOL and
fatigue measures in each study group during the follow-up period will be analyzed with
two-way repeated measures ANOVA, and comparison between the group will be performed using
MANOVA. Multivariate analysis will include General Linear Model (GLM) for each outcome. The
independent variables will include the study group, study period, interaction variable (study
group * period) and the baseline characteristics of the patients. The effect of mediation
(SABRES - fatigue - QOL) will be analyzed with SOBEL test.
