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Fish Oil Supplementation for Vocal Rest

(PVU Trial)

LF
BP
Overseen ByBrittany Perrine, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Baylor University

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for cisgender women over 18, who are pre-menopausal, live in McLennan County, TX, and work in professions that use their voice a lot. Participants must be able to attend sessions at Baylor University.

Inclusion Criteria

I am willing to be placed in either the supplement or placebo group.
I am over 18 years old and still have regular menstrual periods.
consider themselves a professional voice user who uses their voice to do their job
See 3 more

Exclusion Criteria

are unable to pass a hearing screening
are a smoker or tobacco user
are allergic to fish or shellfish
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Omega-3 Polyunsaturated Fatty Acids

Trial Overview

The study tests whether taking omega-3 fish oil supplements affects the voices of female professional voice users compared to a placebo. Voice quality and vocal fold biomarkers will be measured before and after supplementation.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Omega-3 polyunsaturated fatty acidExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials
65
Recruited
67,600+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

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