Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

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

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).

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Dietary supplement: Olive oil and Dietary Guideline recommendations; Other: Dietary Guideline recommendations

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Food Science and Human Nutrition Department, University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olive Oil; Incorporating 60 mL of olive oil into usual diet and Dietary Guidelines recommendations	Dietary supplement: Olive oil and Dietary Guideline recommendations; 60 mL of olive oil and healthy diet recommendations
Active Comparator: Control; Dietary Guidelines recommendations	Other: Dietary Guideline recommendations; healthy diet recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to olive oil intervention	Daily olive oil intake in tablespoons per day.	12 weeks

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Facial Pain; Trigeminal Neuralgia
• Other Study ID Numbers: IRB202100950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No