Voice Range ProfileNCT05141045
The Effect of Fish Oil Supplementation on Vocal Performance
A study testing omega-3 PUFA supplement in people with Voice Range Profile and Reflux Symptom Index, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Range Profile, Reflux Symptom Index, Evaluation of Ability to Sing Easily
- What is being tested?
- omega-3 PUFA supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 13 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Voice Range Profile, Reflux Symptom Index, Evaluation of Ability to Sing Easily, Body Composition
- Being tested
- omega-3 PUFA supplement, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 PUFA supplementDietary supplement
participants were instructed to take 3.0 grams per day of omega-3 PUFA supplement
placeboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| omega-3 PUFA supplement | Experimental | omega-3 PUFA supplement, 3.0 grams per day Receives: Dietary Supplement: omega-3 PUFA supplement |
| placebo | Placebo comparator | safflower oil, 3.0 grams per day Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Evaluation of Ability to Sing Easily
survey designed to aid in subject self-assessment
Measured: baseline and up to 11 weeks
Secondary outcomes (2)
change in Voice Range Profile
known as a phonetogram, is a representation of a participants minimum and maximum intensity levels across vocal range
Measured: baseline and up to 11 weeks
change in Body composition
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
Measured: baseline and up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start8 Feb 2021
- Primary completion13 May 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice Range ProfileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LesLee Funderburk, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141045
- Sponsor's protocol ID
- 1708288-3
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fish Oil Supplementation on Vocal Performance
- ClinicalTrials.gov ID
- NCT05141045
- Acronym / sponsor ID
- 1708288-3
- Conditions
- Voice Range Profile, Reflux Symptom Index, Evaluation of Ability to Sing Easily, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 PUFA supplement | Experimental | Dietary Supplement: omega-3 PUFA supplementomega-3 PUFA supplement, 3.0 grams per day |
| placebo | Placebo comparator | Dietary Supplement: placebosafflower oil, 3.0 grams per day |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 PUFA supplementparticipants were instructed to take 3.0 grams per day of omega-3 PUFA supplement | Dietary supplement | omega-3 PUFA supplement |
| placeboplacebo | Dietary supplement | placebo |
Primary outcome
Change in Evaluation of Ability to Sing Easily
Time frame: baseline and up to 11 weeks
survey designed to aid in subject self-assessment
2 secondary outcomes
change in Voice Range Profile
Time frame: baseline and up to 11 weeks
change in Body composition
Time frame: baseline and up to 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LesLee Funderburk, PhD principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 PUFA supplement in people with Voice Range Profile and Reflux Symptom Index, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Evaluation of Ability to Sing Easily (time frame: baseline and up to 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.