Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression

NCT07585877 | Active Not Recruiting

• 1 other identifier: 2025ZDSYLL321-PO1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia Progressing; Myopia

Keywords

Myopia Progression; Branched-chain amino acids; Nutritional supplementation; Randomized controlled trial; Axial length; OCTA

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

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) Supplementation DIETARY_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

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 25 years
• Currently enrolled university students
• Cycloplegic spherical equivalent refractive error: -6.00 D \< SE ≤ -0.50 D
• Best corrected visual acuity ≥ 0.8
• Corneal curvature between 40.0 and 46.0 D
• Willing and able to comply with study procedures and follow-up visits
• Signed written informed consent

You may not qualify if:

• Strabismus, amblyopia, or other structural ocular abnormalities
• Systemic diseases affecting refractive development (e.g., diabetes, metabolic syndrome, obesity)
• Active ocular disease or history of ocular surgery
• Use of orthokeratology lenses or other myopia control interventions within the past 6 months (washout ≥1 month for low-dose atropine users)
• Use of BCAA supplementation within the past 6 months or abnormal serum BCAA levels
• Known allergy or intolerance to protein/amino acid supplements
• Significant liver or kidney dysfunction
• Any condition deemed unsuitable for participation by the investigator

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital, Southeast University No. 87 Dingjiaqiao Road, Gulou District, Nanjing, Jiangsu Province, China

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Amino Acids, Branched-Chain; Dietary Supplements

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned in a parallel design to one of two groups: a BCAA supplementation group or a control group receiving a matched placebo in addition to standard spectacle correction. Both groups will be followed for approximately six months to evaluate differences in myopia progression and ocular parameters.

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: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)