search
Back to results

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

Primary Purpose

Trigeminal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olive oil and Dietary Guideline recommendations
Dietary Guideline recommendations
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Food Science and Human Nutrition Department, University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olive Oil

Control

Arm Description

Incorporating 60 mL of olive oil into usual diet and Dietary Guidelines recommendations

Dietary Guidelines recommendations

Outcomes

Primary Outcome Measures

Compliance to olive oil intervention
Daily olive oil intake in tablespoons per day.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
May 1, 2023
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT05032573
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olive Oil
Arm Type
Experimental
Arm Description
Incorporating 60 mL of olive oil into usual diet and Dietary Guidelines recommendations
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Dietary Guidelines recommendations
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil and Dietary Guideline recommendations
Intervention Description
60 mL of olive oil and healthy diet recommendations
Intervention Type
Other
Intervention Name(s)
Dietary Guideline recommendations
Intervention Description
healthy diet recommendations
Primary Outcome Measure Information:
Title
Compliance to olive oil intervention
Description
Daily olive oil intake in tablespoons per day.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy J Dahl, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Food Science and Human Nutrition Department, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

We'll reach out to this number within 24 hrs