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临床试验/NCT05032573
NCT05032573已完成不适用

Reducing Facial Pain With an Olive Oil Enriched Diet: A Feasibility Study

University of Florida2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Compliance to olive oil intervention

研究概览

简要总结

This is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by trigeminal neuralgia type 1 (TGN).

详细描述

Trigeminal neuralgia (TGN) pain is debilitating and unpredictable. Alleviation of intensity or frequency to any degree will improve the quality of life of the individuals affected. Current medical treatments for TGN are often not effective. In some cases, the pain is a result of myelin degeneration. If diet can provide the basic building blocks for myelin regrowth, then the investigators may be able to reduce facial pain by supporting the myelin nerve sheath.

Animal studies have shown that a dietary intervention with olive oil favorably impacts myelin but no human study has been conducted to date. The investigators propose undertaking a feasibility study to determine if a comparable intervention may work in a similar way in humans. If olive oil impacts myelin repair, then pain will be decreased by this dietary intervention and quality of life will be improved. However, it is not known if individuals with TNG will be able to consume a diet relatively high in olive oil. Feasibility will include testing the logistics of distributing the olive oil intervention to the study subjects, incorporation of olive oil into the participants' daily diets, and online/distance monitoring of compliance and reporting of pain intensity, pain frequency, and quality of life. This feasibility study will lay the groundwork for potential future studies examining the efficacy of olive oil on alleviating facial pain caused by TNG and may provide data for a power analysis for a future interventional trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with Trigeminal Neuralgia
  • Able to provide written informed consent in English
  • Self-identifying females 18-99 years of age
  • Willing to consume 60 mL (4 tablespoons) of olive oil and accommodating dietary changes, and thereby achieve weight maintenance.
  • Willing to provide information about dietary intake at baseline, at the study midpoint, and at the end of the study to assess dietary changes.
  • Willing to complete online questionnaires associated with the study.
  • Willing and able to provide a valid social security for study payment purposes.
  • Have access to the internet to complete online questionnaires
  • Willing to maintain confidentiality of the Penn Facial Pain Scale

排除标准

  • Do not meet the above criteria.
  • Currently participating in another interventional clinical trial.

结局指标

主要结局

Compliance to olive oil intervention

时间窗: 12 weeks

Daily olive oil intake in tablespoons per day.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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