Consuming of Opuntia Among Women With Fibromyalgia

NCT05230602 | Unknown

• 1 other identifier: 0207-21-SOR
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fibromyalgia (FM)

Outcome Measures

Primary Outcomes (4)

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

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

  Two weeks

• consumption of tzabar fruit has a positive influence on fatigue

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

  Two weeks

• consumption of tzabar fruit has a positive influence on fatigue

  fatigue will be measured using the Hebrew version of the quality-of-life questionnaire SF-36 (Levin-Epstein et al., 1998) higher scores indicate beter QOL and less fatigue

  Two weeks

• consumption of tzabar fruit has a positive influence on depressive symptoms

  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

  Two weeks

Study Arms (2)

Study Group

EXPERIMENTAL

The participants will fill the study scales and will be instructed to eat the tzabar fruit twice a day for two weeks

Dietary Supplement: opuntia (tzabar fruit)

Control Group

NO INTERVENTION

The participants will fill the study scales and will be instructed not to change their diet for two weeks

Interventions

opuntia (tzabar fruit) DIETARY_SUPPLEMENT

consuming of the tzabar fruit twice a day

Study Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Gender Eligibility Details: Fibromyalgia (FM) is a chronic and idiopathic syndrome, characterized by a general distributed pain, more prevalent in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Soroka Medical Center

Beersheba, Southern District, 151, Israel

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Orli Grinstein-Cohen, PhD

  Ben-Gurion University of the Negev/Soroka Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Nursing Department Ben Gurion University

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: February 9, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)