Clinical trial NCT05032573: Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia
Official title: Reducing Facial Pain With an Olive Oil Enriched Diet: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance to olive oil intervention
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and Human Nutrition Department, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: