NCT05032573

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Olive oil and Dietary Guideline recommendations	60 mL of olive oil and healthy diet recommendations
OTHER	Dietary Guideline recommendations	healthy diet recommendations

Timeline

• Start date: 2021-10-05
• Primary completion: 2022-10-31
• Completion: 2023-03-31
• First posted: 2021-09-02
• Last updated: 2024-06-10

Locations

1 site across 1 country: United States