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Completed

NCT Number: NCT05032573

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

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).

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Olive oil and Dietary Guideline recommendations

Dietary Supplement

60 mL of olive oil and healthy diet recommendations

Dietary Guideline recommendations

Other

healthy diet recommendations

Primary outcomes

  1. Compliance to olive oil intervention

    Time frame: 12 weeks

    Daily olive oil intake in tablespoons per day.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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