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Not yet recruitingNCT07800702PVUUpdated Sep 2, 2026

Effect of Fish Oil Supplementation on the Voice of Female Professional Voice Users (PVU)

An interventional study of Omega-3 Polyunsaturated Fatty Acids in Mitigation of Acute Voice Changes Follwing Rigorous Voice Use, sponsored by Baylor University. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Baylor University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The design of the study allows us to test if there are differences in a battery of voice assessments (Aim 1) and biomarkers from vocal fold secretions (Aim 2) over time (within-subjects factor with 6 levels: 3 pre-intervention and 3 post-intervention) secondary to intervention with an omega-3 polyunsaturated fatty acid or a placebo (between-subjects factor with 2 levels).

Cis-gender females (N = 68) over the age of 18 and pre-menopausal from the McLennan County, TX area will serve as participants in this study. This sample size is the minimum needed to show effect for one voice outcome measures, phonation threshold pressure, accounting for a 20% attrition rate. All human subject research will be performed on Baylor University's campus.

Read the detailed description

Estimates of the prevalence of voice problems range from 1.7-7.6% of the U.S. population based on insurance claims and self-reports, respectively. Many of these voice problems originate from phonotraumatic behaviors such as talking too much, too loudly, or in a way that is inefficient. These phonotraumatic behaviors may result in mechanical disruption to the epithelial tissue, the extracellular matrix of the vocal folds, and the basement membrane zone. In some cases there is capillary damage which can lead to the development of a hemorrhage and polyp formation. What follows is 1) an inflammatory response; 2) the extracellular matrix receiving signals to begin tissue repair; and 3) restoration of the epithelial barrier and tissue remodeling. Even without visible tissue damage the vocal folds may still be participating in the repair process to maintain homeostasis, which is the end goal of an acute inflammatory response. While the acute inflammatory response is generally self-limited, there can be a negative impact on vocal production during this time leading people to seek out anti-inflammatory solutions. This project will test the ability of a natural, accessible, and novel approach using supplementation with omega-3 polyunsaturated fatty acids, to mitigate acute vocal fold inflammation and the resulting voice production changes following extreme voice use.

This research will be carried out by the PI, the project team, and a group of undergraduate and graduate students in multiple disciplines across campus (e.g., speech-language pathology, vocal performance, and physiology), allowing the students to have exposure to each step of the research process. The study is a 10-week randomized, double-blind placebo-controlled trial to determine if supplementation using omega-3 PUFA will improve vocal production measures (Aim 1) and reduce inflammatory biomarkers while increasing anti-inflammatory biomarkers (Aim 2) after a vocal loading task. The overall study design (Figure 4) will provide data to be analyzed for both specific aims.

There will be 68 cis-gender females recruited in total. Only females will be used in this stage of the study because of the increased risk of voice disorders in females compared to males.9 Potential participants will be screened and must meet the following inclusionary criteria: 1) willingness to be assigned to either the Figure 4. Study Design of a 10-week randomized, double-blind supplement group or placebo group; 2) over the age of 18; 3) pre-menopausal; 4) consider themselves a professional voice user (PVU) (see below for PVU definition); 5) self-report that their voice gets tired frequently, confirmed by abnormal scores on the first two parts of the Vocal Fatigue Index (Part 1: tiredness of voice and avoidance of voice use; Part 2: physical discomfort); and 6) have a patent nasal cavity. Exclusionary criteria will include: 1) a history of or present self-reported diagnosed voice disorder; 2) diagnosed reflux; 3) a history of or present inflammatory disease; 4) being a vegan; 5) being a smoker; 6) allergies to fish or shellfish; 7) a history of taking a daily omega-3 PUFA supplement in the past 3 months; 8) currently taking a regular anti-inflammatory drug or supplement; 9) a heightened gag reflex; 10) unable to pass a hearing screening; and 11) being concurrently enrolled in voice therapy or receiving treatment from an ear, nose, and throat doctor for a laryngeal problem. If, upon the initial laryngeal examination, the participant presents an abnormal laryngeal exam, as judged by the ENT, they will be removed from the study. Study activities will be scheduled outside of the 7 days prior to the start of their menses.

Professional Voice User. A professional voice user (PVU) is someone who needs their voice to be consistent and appealing to do their job. This could include people such as a salesperson, clerical worker, teacher, receptionist, lawyer or judge, clergy, psychologist, counselor, telephone operator, interviewer or recruiter, public relations specialist, speech-language pathologist, actor or director, broadcaster, or singer. For the purposes of this study, a PVU will be defined as someone who falls into Koufman and Isaccson levels I (elite vocal performers), II (professional voice users), or III (nonvocal professionals). Participants will be asked the following questions to determine if they are a professional voice user: 1) Would your voice not working or sounding like it normally does prevent you from performing your job adequately?; and 2) What percentage of the workday do you need your voice to sound like it normally does to adequately perform your job?. Individuals who answer "yes" to the first question and who indicate they need their voice to sound like it normally does more than 75% of the day will be classified as a professional voice user.

02

Conditions studied

  • Mitigation of Acute Voice Changes Follwing Rigorous Voice Use

Keywords

  • Omega-3 fatty acid, supplementation, professional voice users, intervention
03

In context

Lead sponsor

Baylor University is the lead sponsor of 42 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1) cis-gender female; 2) willingness to be assigned to either the supplement group or placebo group; 3) over the age of the 18 and pre-menopausal; 4) consider themselves a professional voice user, someone who uses their voice to do their job; 5) self-report that their voice gets tired frequently; and 6) have a patent nasal cavity -

Exclusion criteria

Exclusion Criteria:

  • 1) have a history of or present diagnosed voice disorder; 2) diagnosed reflux; 3) have a history of or present inflammatory disease; 4) are pregnant; 5) are a vegan; 6) are a smoker or tobacco user; 7) are allergic to fish or shellfish; 8) have been taking a daily omega-3 PUFA supplement in the past 3 months; 9) take a regular anti-inflammatory drug or supplement; 10) have a heightened gag reflex; 11) are unable to pass a hearing screening; 12) are concurrently enrolled in voice therapy or are receiving treatment from an ear, nose, and throat doctor for a laryngeal problem.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Omega-3 polyunsaturated fatty acid

    3.0 grams of omega-3 PUFAs/day (Nordic Naturals®) for 10 weeks

    Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids

  • Placebo comparator
    Placebo

    3.0 grams of placebo/day (safflower oil, NOW®) for 10 weeks

    Dietary Supplement: Omega-3 Polyunsaturated Fatty Acids

Interventions

  • RCT, double blind study using 3.0 grams of omega-3 PUFAs/day (Nordic Naturals®) or 3.0 grams of placebo/day (safflower oil, NOW®) for 10 weeks

06

What researchers measure

Primary outcomes

  1. Vocal aerodynamic assessment

    A vocal aerodynamic assessment to measure phonation threshold pressure (PTP). Recordings will be made in a double-walled sound attenuating both while the participant is standing. The participant will place a mask system over their face covering the mouth and nose with a small tube that goes between the lips. Participants are able to comfortably breath and speak while wearing the mask and can remove it as they need. Participants will repeat the syllables /pa/ seven times on one breath as softly, smoothly, and evenly as they are able.

    Time frame: 10 weeks, to include baseline and end of study

  2. phonation threshold pressure

    A vocal aerodynamic assessment to measure phonation threshold pressure (PTP). Recordings will be made in a double-walled sound attenuating both while the participant is standing. The participant will place a mask system over their face covering the mouth and nose with a small tube that goes between the lips. Participants are able to comfortably breath and speak while wearing the mask and can remove it as they need. Participants will repeat the syllables /pa/ seven times on one breath as softly, smoothly, and evenly as they are able.

    Time frame: Initial outcome measure will be assessed at baseline, after that baseline assessment, the measure will be collected every 2 weeks until final end of study assessment

Secondary outcomes

  1. Self-administered vocal ratings

    Three self-ratings of voice production using the Self-Administered Vocal Ratings

    Time frame: Initial measure taken at baseline, then 5 weeks after baseline assessment then the last one taken 10 weeks after baseline assessment (end of study)

07

Study locations

1 site
08

References and documents

Publications

  • Perrine BL, Monzon K, Weber LM, Sturdivant RX, Funderburk LK. The Impact of Omega-3 Polyunsaturated Fatty Acid Supplementation on Singing Training in Vocal Performers: A Non-Randomized Double-Blind Placebo-Controlled Study. Folia Phoniatr Logop. 2024;76(4):352-365. doi: 10.1159/000534769. Epub 2023 Oct 30. PubMed 37903469 ↗
  • Perrine BL, Monzon K, Weber LM, Funderburk LK. The Impact of Fish Oil Supplementation on Self-Perception of the Voice in Vocal Performers: A Randomized, Single-Blind, Placebo-Controlled Study. J Speech Lang Hear Res. 2021 Dec 13;64(12):4784-4790. doi: 10.1044/2021_JSLHR-21-00295. Epub 2021 Oct 27. PubMed 34705542 ↗
  • Roy N, Merrill RM, Thibeault S, Gray SD, Smith EM. Voice disorders in teachers and the general population: effects on work performance, attendance, and future career choices. J Speech Lang Hear Res. 2004 Jun;47(3):542-51. doi: 10.1044/1092-4388(2004/042). PubMed 15212567 ↗
  • Roy N, Merrill RM, Gray SD, Smith EM. Voice disorders in the general population: prevalence, risk factors, and occupational impact. Laryngoscope. 2005 Nov;115(11):1988-95. doi: 10.1097/01.mlg.0000179174.32345.41. PubMed 16319611 ↗
  • Cohen SM, Kim J, Roy N, Asche C, Courey M. Direct health care costs of laryngeal diseases and disorders. Laryngoscope. 2012 Jul;122(7):1582-8. doi: 10.1002/lary.23189. Epub 2012 Apr 27. PubMed 22544473 ↗
  • Titze IR, Lemke J, Montequin D. Populations in the U.S. workforce who rely on voice as a primary tool of trade: a preliminary report. J Voice. 1997 Sep;11(3):254-9. doi: 10.1016/s0892-1997(97)80002-1. PubMed 9297668 ↗
  • Perrine BL, Knepler K, Hooper M. Vocal Hygiene Habits in College Students With and Without Self-Reported Symptoms of a Voice Problem. J Voice. 2026 Jul;40(4):1241.e9-1241.e21. doi: 10.1016/j.jvoice.2024.03.004. Epub 2024 Mar 28. PubMed 38553318 ↗
  • Wingate JM, Brown WS, Shrivastav R, Davenport P, Sapienza CM. Treatment outcomes for professional voice users. J Voice. 2007 Jul;21(4):433-49. doi: 10.1016/j.jvoice.2006.01.001. Epub 2006 Apr 3. PubMed 16581229 ↗
  • Vilkman E. Voice problems at work: A challenge for occupational safety and health arrangement. Folia Phoniatr Logop. 2000 Jan-Jun;52(1-3):120-5. doi: 10.1159/000021519. PubMed 10474011 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Mar 2029, 29 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2026
First posted
Sep 2, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Mar 2029
CompletionEst.
Jun 2029
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07800702
Lead sponsor
Baylor University
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Jun 2029 (estimated)
Last update
Sep 2, 2026

Study contacts

LesLee Funderburk, PhD
Contact
leslee_funderburk@baylor.edu
254-710-7318
Brittany Perrine, PhD
Contact
254-710-2587

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Omega-3 fatty acid

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