NCT05141045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 17, 2021

Last Update Submit

November 19, 2021

Conditions

Voice Range ProfileReflux Symptom IndexEvaluation of Ability to Sing EasilyBody Composition

Outcome Measures

Primary Outcomes (1)

  • Change in Evaluation of Ability to Sing Easily

    survey designed to aid in subject self-assessment

    baseline and up to 11 weeks

Secondary Outcomes (2)

  • change in Voice Range Profile

    baseline and up to 11 weeks

  • change in Body composition

    baseline and up to 11 weeks

Study Arms (2)

omega-3 PUFA supplement

EXPERIMENTAL

omega-3 PUFA supplement, 3.0 grams per day

Dietary Supplement: omega-3 PUFA supplement

placebo

PLACEBO COMPARATOR

safflower oil, 3.0 grams per day

Dietary Supplement: placebo

Interventions

omega-3 PUFA supplementDIETARY_SUPPLEMENT

participants were instructed to take 3.0 grams per day of omega-3 PUFA supplement

omega-3 PUFA supplement
placeboDIETARY_SUPPLEMENT

placebo

placebo

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

Study Officials

  • LesLee Funderburk, PhD

    Baylor University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 2, 2021

Study Start

February 8, 2021

Primary Completion

May 13, 2021

Study Completion

May 13, 2021

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)