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

NCT07800702 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-09-02

No results posted yet for this 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.

Conditions

  • Mitigation of Acute Voice Changes Follwing Rigorous Voice Use

Interventions

DIETARY_SUPPLEMENT

Omega-3 Polyunsaturated Fatty Acids

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

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Baylor University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-03-31
Completion
2029-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800702 on ClinicalTrials.gov