NCT07585877

Brief Summary

This study is a randomized controlled trial designed to evaluate whether branched-chain amino acid (BCAA) supplementation can help slow the progression of myopia in young adults. Eligible participants will be randomly assigned to receive either BCAA supplementation combined with standard spectacle correction or standard spectacle correction with a matching placebo. The intervention period will last approximately six months. Participants will undergo regular follow-up examinations, including measurements of visual acuity, refractive error, axial length, intraocular pressure, and other ocular parameters. Additional assessments such as ocular imaging (including OCTA), physical examinations, and blood tests will also be performed to evaluate eye health and metabolic indicators. The main purpose of this study is to investigate whether BCAA supplementation can provide a safe and effective nutritional strategy to slow myopia progression and improve understanding of the relationship between amino acid metabolism and ocular growth.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
active not 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 Progress53%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 5, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

April 23, 2026

Last Update Submit

July 9, 2026

Conditions

Myopia ProgressingMyopia

Keywords

Myopia ProgressionBranched-chain amino acidsNutritional supplementationRandomized controlled trialAxial lengthOCTA

Outcome Measures

Primary Outcomes (2)

  • Change in axial length

    Axial length (AL) will be measured in both eyes using optical biometry at baseline, 3 months, and 6 months. The primary outcome is the change in axial length from baseline to 6 months, comparing the BCAA supplementation plus spectacle correction group with the spectacle correction only group.

    Baseline to 6 months

  • Change in spherical equivalent refractive error

    Cycloplegic spherical equivalent (SE) will be measured using autorefractometry under cycloplegia at baseline, 3 months, and 6 months. The primary outcome is the change in spherical equivalent refractive error from baseline to 6 months, comparing the BCAA supplementation group with the control group.

    Baseline to 6 months

Secondary Outcomes (69)

  • Superficial retinal vessel density

    Baseline and 6 months

  • Deep retinal vessel density

    Baseline and 6 months

  • Choriocapillaris perfusion density

    Baseline and 6 months

  • Retinal perfusion density

    Baseline and 6 months

  • Family Ocular History

    Baseline

  • +64 more secondary outcomes

Study Arms (2)

BCAA Supplementation Group

EXPERIMENTAL

Participants receive daily oral branched-chain amino acid (BCAA) supplementation in addition to standard spectacle correction. The intervention is administered for approximately 6 months to evaluate its effect on myopia progression and ocular parameters.

Dietary Supplement: Branched-Chain Amino Acids (BCAA) Supplementation

Control Group

NO INTERVENTION

Participants in the control group will receive standard spectacle correction combined with a placebo identical in appearance to the BCAA supplement, without active BCAA ingredients. They will be followed for approximately 6 months to evaluate myopia progression and ocular outcomes.

Interventions

Branched-Chain Amino Acids (BCAA) SupplementationDIETARY_SUPPLEMENT

Participants will receive oral branched-chain amino acids (BCAA), including leucine, isoleucine, and valine, as a dietary supplement in addition to standard spectacle correction. The intervention is administered daily for approximately 6 months. The supplement is a commercially available nutritional product obtained via cross-border e-commerce channels and is not intended as a therapeutic drug. The aim is to evaluate the effect of BCAA supplementation on myopia progression and ocular biometric parameters.

Also known as: BCAA, Branched-chain amino acids
BCAA Supplementation Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy university students aged 18-25 years;
  • Spherical equivalent refraction (for eyes without prior corneal refractive surgery): SE ≤ -0.50 D;
  • Corrected visual acuity ≥ 0.8;
  • Corneal curvature 40 D-46 D;
  • Good compliance and ability to cooperate with follow-up and examinations;
  • Willingness and ability to participate in this study and sign the informed consent form.

You may not qualify if:

  • Strabismus, amblyopia, or other pathological ocular changes;
  • Systemic diseases affecting refractive development and allergic constitution, such as diabetes, metabolic syndrome, etc.;
  • Active eye disease or history of ophthalmic surgery;
  • Use of orthokeratology lenses or other myopia-control interventions within the past 6 months;
  • Use of BCAA-related supplements within the past 6 months, or serum BCAA levels outside the reference range;
  • Considered by the responsible physician to be unable to participate or unable to comply with the study requirements;
  • Abnormal liver or kidney function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, Southeast University

Nanjing, Jiangsu, 210096, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Amino Acids, Branched-ChainDietary Supplements

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Ophthalmic examiners and personnel performing blood sample collection are also blinded to group assignment, although they are not involved in outcome evaluation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a parallel design to one of two groups: (1) spectacle correction (regular single-vision or myopia-control lenses) plus BCAA supplementation, or (2) spectacle correction (regular single-vision or myopia-control lenses) plus matched placebo supplementation. Both groups will be followed for approximately six months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 14, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)