Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

NCT05032573 | Completed

• 1 other identifier: IRB202100950
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• Compliance to olive oil intervention

  Daily olive oil intake in tablespoons per day.

  12 weeks

Study Arms (2)

Olive Oil

EXPERIMENTAL

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

Dietary Supplement: Olive oil and Dietary Guideline recommendations

Control

ACTIVE COMPARATOR

Dietary Guidelines recommendations

Other: Dietary Guideline recommendations

Interventions

Olive oil and Dietary Guideline recommendations DIETARY_SUPPLEMENT

60 mL of olive oil and healthy diet recommendations

Olive Oil

Dietary Guideline recommendations OTHER

healthy diet recommendations

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• Moreno ML, Percival SS, Kelly DL, Dahl WJ. Daily olive oil intake is feasible to reduce trigeminal neuralgia facial pain: A pilot study. Nutr Res. 2024 Mar;123:101-110. doi: 10.1016/j.nutres.2024.01.005. Epub 2024 Jan 10.

  PMID: 38306883 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wendy J Dahl, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: October 5, 2021
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2023
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)