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

Part of paid clinical trials in Waco, Texas.

Sponsor
Baylor University
Study ID
NCT07800702
Status
Not Yet Recruiting

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Conditions

  • Mitigation of Acute Voice Changes Follwing Rigorous Voice Use

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Omega-3 polyunsaturated fatty acid
    3.0 grams of omega-3 PUFAs/day (Nordic Naturals®) for 10 weeks
  • Placebo Comparator: Placebo
    3.0 grams of placebo/day (safflower oil, NOW®) for 10 weeks

Primary Outcome Measure

Vocal aerodynamic assessment [ Time Frame: 10 weeks, to include baseline and end of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor UniversityWacoTexas76798
April Swindell
[email protected]
254-710-6812

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By research site
Baylor University· Waco, TX