- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141045
The Effect of Fish Oil Supplementation on Vocal Performance
November 19, 2021 updated by: Baylor University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Waco, Texas, United States, 76798
- Baylor University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: omega-3 PUFA supplement
omega-3 PUFA supplement, 3.0 grams per day
|
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
|
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Evaluation of Ability to Sing Easily
Time Frame: baseline and up to 11 weeks
|
survey designed to aid in subject self-assessment
|
baseline and up to 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Voice Range Profile
Time Frame: baseline and up to 11 weeks
|
known as a phonetogram, is a representation of a participants minimum and maximum intensity levels across vocal range
|
baseline and up to 11 weeks
|
change in Body composition
Time Frame: 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
|
baseline and up to 11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: LesLee Funderburk, PhD, Baylor University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2021
Primary Completion (Actual)
May 13, 2021
Study Completion (Actual)
May 13, 2021
Study Registration Dates
First Submitted
November 17, 2021
First Submitted That Met QC Criteria
November 19, 2021
First Posted (Actual)
December 2, 2021
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 19, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1708288-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Composition
-
Nova Southeastern UniversityCompleted
-
Centro Universitario de Ciencias de la Salud, MexicoCompleted
-
University of Southern CaliforniaCompleted
-
University of California, San FranciscoHologic, Inc.Completed
-
University of SurreyUnknownBody Composition
-
Texas Woman's UniversityCompleted
-
Auburn UniversityCompletedBody CompositionUnited States
-
Universidad de ZaragozaUnknown
-
University Hospital, Clermont-FerrandCenter of study in Human Nutrition, INRA, Department of Clinical NutritionCompleted
-
Muğla Sıtkı Koçman UniversityBahçeşehir UniversityCompleted
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States