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

The Effect of Fish Oil Supplementation on the Voice of Female Professional Voice Users

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.

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.

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:

• 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.