About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Omega-3 Polyunsaturated Fatty Acids
Dietary supplement
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

Treatment groups

68 Participants

are divided into 2 treatment groups

Group A: Omega-3 polyunsaturated fatty acidExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts