Creatine Supplementation for Improved Voice Performance in the Elderly

The primary objective of this study is to determine if creatine supplementation improves acoustic, auditory perceptual, physiologic, and patient-reported outcome measures in patients over 65 years of age. In the study, 20 participants will be enrolled and randomly assigned to receive either creatine or placebo.

Study Overview

• Status: Suspended
• Conditions: Presbyphonia
• Intervention / Treatment: Dietary supplement: Creatine monohydrate; Dietary supplement: Placebo

Detailed Description

This will be a double-blinded, placebo-controlled interventional trial. Participants will be 65 years or older who present to the NYU voice center for voice complaints and desired voice therapy for improved vocal performance. Upon enrollment, participants will undergo evaluation for measures of vocal function (acoustic and aerodynamic measures of voice production), laryngeal physiology (electroglottography, videostroboscopy), and voice-associated quality of life (voice handicap index 10 , OMNI vocal effort scale, aging voice index). Participants will be randomized to receive either daily oral creatine supplementation or placebo. After 4 weeks, repeat measures will be taken. At this time, participants will initiate a standard-of-care course of voice therapy directed at improved vocal strength and endurance. The duration of therapy will be approximately 6 weeks. Participants will continue creatine supplementation or placebo through the course of therapy and repeat measures will be assessed at the conclusion of voice therapy. This will mark the end of the study period for each subject.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 65 years or older
2. Desiring to participate in voice therapy

Exclusion Criteria:

1. Lesions or abnormalities of the larynx not attributable to normal aging
2. Pre-existing renal disease
3. Pre-existing liver disease
4. Congestive heart failure
5. Blood urea nitrogen (BUN), creatine, alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT) over reference range in the last 6 months
6. Concurrent medication associated with reduced renal clearance (e.g. Nonsteroidal Anti-inflammatory Drugs (NSAIDs), metformin)
7. History of prior vocal fold augmentation procedures
8. Cognitive disability
9. Unwillingness to participate in voice therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creatine Supplementation; Participants randomized to receive creatine. Study participants will be asked to track their daily administration on a log provided by the study team.	Dietary supplement: Creatine monohydrate; Creatine monohydrate will be self-administered by an oral route at a dose of 5g/day in powdered form. Administration will begin on Study Day 1 and continue for 10 weeks.; Other Names: Creapure
Placebo Comparator: Placebo; Participants randomized to receive placebo. Study participants will be asked to track their daily administration on a log provided by the study team.	Dietary supplement: Placebo; Placebo (in the form of lactose) will be self-administered by an oral route at a dose of 5g/day in powdered form. Administration will begin on Study Day 1 and continue for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Voice Handicap Index (VHI)-10 Scores	10-item questionnaire assessing a patient's perception of impairment or handicap due to a voice problem. Items are ranked on a scale ranging from 0 to 4, where 0 = Never and 4 = Always. The total score ranges from 0-40; higher scores indicate greater impairment or handicap due to a voice problem.	Baseline, Week 10
Average Expert Rating of Change in Mucosal Wave	Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in mucosal wave on a relative 3-point scale (1 = worse, 2 = same, 3 = better).	Week 10
Average Expert Rating of Change in Vocal Fold Atrophy	Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in vocal fold atrophy on a relative 3-point scale (1 = worse, 2 = same, 3 = better).	Week 10
Average Expert Rating of Change in Glottal Closure	Videostroboscopic clips will be collected during clinical visits (baseline and Week 10). The clips will be sent to 6 expert reviewers, who will rate change in glottal closure on a relative 3-point scale (1 = worse, 2 = same, 3 = better).	Week 10
Average Phonatory Pressure during Aerodynamic Analysis of Voice	Patients are instructed to produce five productions of /pa/ at their most comfortable pitch and loudness at a rate of approximately 1.5 syllables per second. The middle three productions will be analyzed to determine the average phonatory pressure.	Up to Week 10
Average Decibel (dB) Output during Aerodynamic Analysis of Voice	Patients are instructed to produce five productions of /pa/ at their most comfortable pitch and loudness at a rate of approximately 1.5 syllables per second. The middle three productions will be analyzed to determine the average dB output.	Up to Week 10

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Aaron Johnson, Aaron.Johnson@nyulangone.org

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: creatine; presbyphonia; presbylarynx; vocal atrophy
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Organic Chemicals; Amino Acids; Guanidines; Amidines; Creatine
• Other Study ID Numbers: 22-01536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a single institution study and all patient data will be limited to the primary research team

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No