NCT07466407

Brief Summary

This randomized, double-blind, placebo-controlled clinical trial evaluates the effects of oral beta-hydroxy-beta-methylbutyrate (HMB) supplementation combined with an eccentric exercise and extracorporeal shockwave rehabilitation program on pain, tendon morphology, and neuromuscular performance in athletes with patellar tendinopathy. Thirty athletes with a confirmed diagnosis of patellar tendinopathy are randomized to receive either HMB supplementation (3 g/day) or placebo during an 8-week rehabilitation program. Participants are evaluated at baseline, week 4, and week 8. The primary outcome is pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Secondary outcomes include patellar tendon thickness measured by ultrasound imaging, countermovement jump (CMJ) performance, and neuromuscular performance variables derived from an incremental squat test using a linear position transducer. The aim of the study is to determine whether HMB supplementation enhances clinical recovery and neuromuscular performance when combined with a standardized rehabilitation program compared with placebo.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 26, 2026

Last Update Submit

March 9, 2026

Conditions

Patellar Tendinopathy

Keywords

TendinopathyHMBRehabilitationKnee painSports injuryNutritional supplementBeta-hydroxy-beta-methylbutyrate

Outcome Measures

Primary Outcomes (1)

  • VISA-P Score

    Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.

    Baseline (PRE), Week 4 (INT), and Week 8 (POST)

Secondary Outcomes (5)

  • Patellar tendon thickness

    Baseline (PRE), Week 4 (INT), and Week 8 (POST)

  • Countermovement Jump (CMJ)

    Baseline (PRE), Week 4 (INT), and Week 8 (POST)

  • Peak Power (PP) during squat test

    Baseline (PRE), Week 4 (INT), and Week 8 (POST)

  • Peak Power Relative to Body Mass (PPkg)

    Baseline (PRE), Week 4 (INT), and Week 8 (POST)

  • Mean Velocity at Peak Power (PPmv)

    Baseline (PRE), Week 4 (INT), and Week 8 (POST)

Study Arms (2)

HMB Supplement + Rehabilitation Program

EXPERIMENTAL

Participants receive beta-hydroxy-beta-methylbutyrate (HMB) supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.

Other: Eccentric exercise and extracorporeal shock wave therapyDietary Supplement: Beta-hydroxy-beta-methylbutyrate (HMB)

Placebo + Rehabilitation Program

PLACEBO COMPARATOR

Participants receive placebo supplementation in combination with a rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.

Other: Eccentric exercise and extracorporeal shock wave therapy

Interventions

Eccentric exercise and extracorporeal shock wave therapyOTHER

Participants undergo a standardized rehabilitation program consisting of eccentric exercise and extracorporeal shock wave therapy.

HMB Supplement + Rehabilitation ProgramPlacebo + Rehabilitation Program
Beta-hydroxy-beta-methylbutyrate (HMB)DIETARY_SUPPLEMENT

Participants ingest 3 g/day of beta-hydroxy-beta-methylbutyrate (HMB) in capsule form, administered 60 minutes before each eccentric training session during the 8-week intervention period.

HMB Supplement + Rehabilitation Program

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 49 years
  • Clinical diagnosis of patellar tendinopathy confirmed by a physician and physiotherapist
  • Competitive athlete in sports involving repetitive knee loading (e.g., basketball, volleyball, handball, athletics)
  • Minimum training frequency of three sessions per week
  • No knee surgery within the previous 12 months
  • No nutritional supplementation within the previous 3 months
  • No injection therapy (analgesics or platelet-rich plasma) within the previous 12 months
  • Non-smoker
  • Signed informed consent

You may not qualify if:

  • Any musculoskeletal injury other than patellar tendinopathy affecting performance
  • Systemic disease affecting musculoskeletal function
  • Inability to comply with the rehabilitation or supplementation protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Fisio-Agil

Córdoba, Córdoba, 14007, Spain

Location

Related Publications (1)

  • Sanchez-Gomez A, Jurado-Castro JM, Mata F, Sanchez-Oliver AJ, Dominguez R. Effects of beta-Hydroxy beta-Methylbutyric Supplementation in Combination with Conservative Non-Invasive Treatments in Athletes with Patellar Tendinopathy: A Pilot Study. Int J Environ Res Public Health. 2022 Jan 1;19(1):471. doi: 10.3390/ijerph19010471.

    PMID: 35010730BACKGROUND

MeSH Terms

Conditions

TendinopathyAthletic Injuries

Interventions

Extracorporeal Shockwave Therapybeta-hydroxyisovaleric acid

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Juan J Ramos-Álvarez, MD

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan J Ramos-Álvarez, MD

CONTACT

+34 913941367jjramosa@ucm.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind study. Both participants and investigators were unaware of group assignment (HMB or placebo). Capsules were identical in color and appearance, and the allocation code was not disclosed until all data were collected.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study followed a randomized, double-blind, parallel-group design. Thirty athletes with diagnosed patellar tendinopathy were randomly assigned to one of two groups: (1) HMB supplementation plus rehabilitation program, or (2) placebo supplementation plus the same rehabilitation program. The intervention period lasted 8 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 12, 2026

Study Start

March 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)