The Effect of Fish Oil Supplementation on Vocal Performance

• Sponsor: Baylor University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05141045
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 13.9

Study Details

Study Description

Brief Summary

The purpose of this study was to determine if use of omega-3 PUFA supplement in combination with a singer's training regimen enhances training adaptations and body composition.

Condition or Disease	Intervention/Treatment	Phase
Voice Range Profile; Reflux Symptom Index; Evaluation of Ability to Sing Easily; Body Composition	Dietary Supplement: omega-3 PUFA supplement; Dietary Supplement: placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Effect of Fish Oil Supplementation on Vocal Performance
• Actual Study Start Date: Feb 8, 2021
• Actual Primary Completion Date: May 13, 2021
• Actual Study Completion Date: May 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: omega-3 PUFA supplement omega-3 PUFA supplement, 3.0 grams per day	Dietary Supplement: omega-3 PUFA supplement; participants were instructed to take 3.0 grams per day of omega-3 PUFA supplement
Placebo Comparator: placebo safflower oil, 3.0 grams per day	Dietary Supplement: placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Change in Evaluation of Ability to Sing Easily [baseline and up to 11 weeks]

   survey designed to aid in subject self-assessment

Secondary Outcome Measures

1. change in Voice Range Profile [baseline and up to 11 weeks]

   known as a phonetogram, is a representation of a participants minimum and maximum intensity levels across vocal range

2. change in Body composition [baseline and up to 11 weeks]

   height in cm, weight measured in kg. Bio-electrical impedance scale use to assess lean and body fat mass, measured in kg. Weight and height were combined to report BMI in kg/m^2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 28 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Apparently healthy college vocal performers (male and female of all ethnicities) *Between the ages of 18-28 years

• Majoring in classical voice in the Baylor University School of Music or musical theatre in the Baylor University Department of Theatre Arts.

Exclusion Criteria:

• Previously diagnosed with a voice disorder

• Vegans

• Smokers

• Allergic to fish, shellfish or safflower oil

• Have been taking daily FO n-3 supplement within the past three months, or any supplement known to effect muscle biology (e.g. creatine).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baylor University	Waco	Texas	United States	76798

Sponsors and Collaborators

• Baylor University

Investigators

• Principal Investigator: LesLee Funderburk, PhD, Baylor University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baylor University
• ClinicalTrials.gov Identifier: NCT05141045
• Other Study ID Numbers: 1708288-3
• First Posted: Dec 2, 2021
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 2, 2021