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OpenTrials
Active, Not Recruiting

NCT Number: NCT07585877

Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health, Southeast University

Nanjing, Jiangsu, 210096, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: BCAA, Branched-chain amino acids

Primary outcomes

  1. Change in axial length

    Time frame: Baseline to 6 months

    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.

  2. Change in spherical equivalent refractive error

    Time frame: Baseline to 6 months

    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.

Secondary outcomes

  1. Superficial retinal vessel density

    Time frame: Baseline and 6 months

    Superficial retinal vessel density will be measured in both eyes using OCTA in foveal, parafoveal, and perifoveal regions. Sectoral measurements (temporal, superior, nasal, and inferior) will be obtained, and the final value will be calculated as the mean of all regions, reported as a percentage (%).

  2. Deep retinal vessel density

    Time frame: Baseline and 6 months

    Deep retinal vessel density will be measured in both eyes using OCTA across ETDRS regions. Sectoral measurements will be obtained, and the final value will be calculated as the mean of all regions, reported as a percentage (%).

  3. Choriocapillaris perfusion density

    Time frame: Baseline and 6 months

    Choriocapillaris perfusion will be measured in both eyes using OCTA across foveal, parafoveal, and perifoveal regions. Sectoral measurements will be obtained, and the final value will be calculated as the mean of all regions, reported as a percentage (%).

  4. Retinal perfusion density

    Time frame: Baseline and 6 months

    Retinal perfusion density will be measured in both eyes using OCTA across ETDRS regions, including full retinal perfusion and large-vessel-excluded perfusion. Sectoral measurements will be obtained, and the final value will be calculated as the mean of all regions, reported as a percentage (%).

  5. Family Ocular History

    Time frame: Baseline

    Definition: Baseline refractive status of parents based on self-reported highest degree of myopia in either eye.

    Variable type: Categorical Measurement: Self-reported parental myopia status categorized as none, low (≤300°), moderate (300-600°), and high (≥600°).

  6. Nutritional Supplement Use

    Time frame: Baseline

    Definition: Baseline information on participants' use of any nutritional or dietary supplements.

    Variable type: Binary (Yes/No) Measurement: Self-reported use of dietary or nutritional supplements (Yes/No).

  7. Protein Allergy History

    Time frame: Baseline

    Definition: Baseline assessment of whether participants have a documented or self-reported history of protein allergy.

    Variable type: Binary (Yes/No) Measurement: Self-reported history of protein allergy (Yes/No).

  8. Parental Education Level

    Time frame: Baseline

    Parental education level at baseline, self-reported via structured questionnaire. Education levels are categorized as: primary school or below, junior/high school, university, and master's degree or above.Variable Type:Categorical

  9. Daily Screen Time

    Time frame: Baseline

    Average daily time spent using electronic devices (including television, mobile phone, computer, and projection screen) over the past week, assessed by questionnaire. Variable type: Categorical.

  10. Eye Rest and Break Behavior

    Time frame: Baseline

    Definition: Frequency of eye breaks during near work activities. Variable type: Categorical Measurement: Self-reported duration of continuous near work before rest (≤30 min, 30-60 min, 1-2 h, 2-3 h, ≥3 h).

  11. Sleep Duration

    Time frame: Baseline

    Definition: Average daily sleep duration over the past week. Variable type: Continuous Measurement: Self-reported average sleep time (hours and minutes per day).

  12. Staple food intake frequency

    Time frame: Baseline

    Frequency and quantity of staple food intake, including rice, wheat-based products, corn products, mixed beans, tubers, and fried flour-based foods, assessed using a semi-quantitative food frequency questionnaire.

  13. Protein-rich food intake frequency

    Time frame: Baseline

    Frequency and quantity of protein-rich food consumption, including soybeans and soy products, meat (pork, beef, lamb, poultry), aquatic products (fish, shrimp, shellfish), eggs, and dairy products, assessed using a semi-quantitative food frequency questionnaire.

  14. Vegetable intake frequency

    Time frame: Baseline

    Frequency and quantity of vegetable intake, including dark green vegetables, red/orange vegetables, purple vegetables, and light-colored vegetables, assessed using a semi-quantitative food frequency questionnaire.

  15. Fruit intake frequency

    Time frame: Baseline

    Frequency and quantity of fruit intake, including pome fruits, citrus fruits, stone fruits, berries, melons, and tropical fruits, assessed using a semi-quantitative food frequency questionnaire.

  16. Dairy product intake frequency

    Time frame: Baseline

    Frequency and quantity of dairy product consumption, including liquid milk, milk powder, and yogurt, assessed using a semi-quantitative food frequency questionnaire.

  17. Snack and sugary food intake frequency

    Time frame: Baseline

    Frequency and quantity of intake of snacks and sugary foods, including baked goods, nuts, processed snacks, sweets, and sugar-sweetened beverages, assessed using a semi-quantitative food frequency questionnaire.

  18. Temporal Superior RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary retinal nerve fiber layer (RNFL) thickness in the temporal superior (TU) sector measured by optical coherence tomography angiography (OCTA), reported in micrometers (µm).

  19. Superior Temporal RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the superior temporal (ST) sector measured by OCTA, reported in micrometers (µm).

  20. Superior Nasal RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the superior nasal (SN) sector measured by OCTA, reported in micrometers (µm).

  21. Nasal Superior RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the nasal superior (NU) sector measured by OCTA, reported in micrometers (µm).

  22. Nasal Inferior RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the nasal inferior (NL) sector measured by OCTA, reported in micrometers (µm).

  23. Inferior Nasal RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the inferior nasal (IN) sector measured by OCTA, reported in micrometers (µm).

  24. Inferior Temporal RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the inferior temporal (IT) sector measured by OCTA, reported in micrometers (µm).

  25. Temporal Inferior RNFL Thickness

    Time frame: Baseline and 6 months

    Peripapillary RNFL thickness in the temporal inferior (TL) sector measured by OCTA, reported in micrometers (µm).

  26. Global Average Peripapillary RNFL Thickness

    Time frame: Baseline and 6 months

    Global average peripapillary retinal nerve fiber layer (RNFL) thickness measured by optical coherence tomography angiography (OCTA), calculated as the mean thickness across all peripapillary regions, and reported in micrometers (µm).

  27. Optic Disc Area

    Time frame: Baseline and 6 months

    Optic disc area measured in both eyes using optical coherence tomography angiography (OCTA), reported in square millimeters (mm²).

  28. Neuroretinal Rim Area

    Time frame: Baseline and 6 months

    Neuroretinal rim area measured in both eyes using OCTA, reported in square millimeters (mm²).

  29. Optic Cup Volume

    Time frame: Baseline and 6 months

    Optic cup volume measured in both eyes using OCTA, reported in cubic millimeters (mm³).

  30. Cup-to-Disc Ratio

    Time frame: Baseline and 6 months

    Cup-to-disc ratio measured in both eyes using OCTA, defined as the ratio of optic cup diameter to optic disc diameter (unitless).

  31. Vertical Cup-to-Disc Ratio

    Time frame: Baseline and 6 months

    Vertical cup-to-disc ratio measured in both eyes using OCTA (unitless).

  32. Horizontal Cup-to-Disc Ratio

    Time frame: Baseline and 6 months

    Horizontal cup-to-disc ratio measured in both eyes using OCTA (unitless).

  33. Peripapillary Temporal Superior Sector Vessel Density

    Time frame: Baseline and 6 months

    Peripapillary microvascular vessel density in the temporal superior (TU) sector measured in both eyes using optical coherence tomography angiography (OCTA), reported as vessel density percentage (%).

  34. Peripapillary Superior Temporal Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the superior temporal (ST) peripapillary sector in both eyes,reported as vessel density percentage (%).

  35. Peripapillary Superior Nasal Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the superior nasal (SN) peripapillary sector in both eyes,reported as vessel density percentage (%).

  36. Peripapillary Nasal Superior Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the nasal superior (NU) peripapillary sector in both eyes,reported as vessel density percentage (%).

  37. Peripapillary Nasal Inferior Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the nasal inferior (NL) peripapillary sector in both eyes,

  38. Peripapillary Inferior Nasal Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the inferior nasal (IN) peripapillary sector in both eyes,reported as vessel density percentage (%).

  39. Peripapillary Inferior Temporal Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the inferior temporal (IT) peripapillary sector in both eyes,reported as vessel density percentage (%).

  40. Peripapillary Temporal Inferior Sector Vessel Density

    Time frame: Baseline and 6 months

    OCTA-derived vessel density in the temporal inferior (TL) peripapillary sector in both eyes,reported as vessel density percentage (%).

  41. Global Peripapillary Vessel Density

    Time frame: Baseline and 6 months

    Mean peripapillary microvascular vessel density calculated across all peripapillary sectors in both eyes using OCTA,reported as vessel density percentage (%).

  42. Full Macular Retinal Thickness

    Time frame: Baseline and 6 months

    Full retinal thickness in the macular region measured in both eyes using optical coherence tomography angiography (OCTA), including foveal, parafoveal, and perifoveal regions across temporal, superior, nasal, and inferior sectors.

  43. Macular Inner Retinal Layer Thickness

    Time frame: Baseline and 6 months

    Inner retinal layer thickness in the macular region measured in both eyes using OCTA, assessed at foveal, parafoveal, and perifoveal regions across four quadrants (temporal, superior, nasal, inferior).

  44. Macular Outer Retinal Layer Thickness

    Time frame: Baseline and 6 months

    Outer retinal layer thickness in the macular region measured in both eyes using OCTA, including foveal, parafoveal, and perifoveal regions across temporal, superior, nasal, and inferior sectors.

  45. Foveal Avascular Zone Area

    Time frame: Baseline and 6 months

    Foveal avascular zone (FAZ) area measured in both eyes using optical coherence tomography angiography (OCTA).

  46. FAZ-300 Superficial Capillary Plexus Perfusion Density

    Time frame: Baseline and 6 months

    Perfusion density in a 300 μm annular region surrounding the FAZ in the superficial capillary plexus measured using OCTA.

  47. FAZ-300 Deep Capillary Plexus Perfusion Density

    Time frame: Baseline and 6 months

    Perfusion density in a 300 μm annular region surrounding the FAZ in the deep capillary plexus measured using OCTA.

  48. FAZ-300 Full Retinal Perfusion Density

    Time frame: Baseline and 6 months

    Perfusion density in a 300 μm annular region surrounding the FAZ across full retinal layers measured using OCTA.

  49. Alanine Aminotransferase (ALT)

    Time frame: Baseline and 6 months

    Serum alanine aminotransferase (ALT) measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  50. Aspartate Aminotransferase (AST)

    Time frame: Baseline and 6 months

    Serum AST measured using standard laboratory methods in fasting venous blood. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  51. Total Bilirubin (TBil)

    Time frame: Baseline and 6 months

    Serum total bilirubin measured in fasting venous blood. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  52. Serum Creatinine (Scr)

    Time frame: Baseline and 6 months

    Serum creatinine measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  53. Blood Urea Nitrogen (BUN)

    Time frame: Baseline and 6 months

    BUN measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  54. Uric Acid (UA)

    Time frame: Baseline and 6 months

    Serum uric acid measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  55. Fasting Plasma Glucose (FPG)

    Time frame: Baseline and 6 months

    Fasting plasma glucose measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  56. Total Cholesterol (TC)

    Time frame: Baseline and 6 months

    Serum total cholesterol measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  57. Triglycerides (TG)

    Time frame: Baseline and 6 months

    Serum triglycerides measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  58. High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline and 6 months

    HDL cholesterol measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  59. Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline and 6 months

    LDL cholesterol measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.

  60. Sex of Participants

    Time frame: Baseline

    Participant sex recorded at baseline using structured questionnaire.

  61. Age of Participants

    Time frame: Baseline

    Age calculated from date of birth at baseline using structured questionnaire.

  62. Ethnicity of Participants

    Time frame: Baseline

    Ethnicity recorded at baseline using structured questionnaire.

  63. Body Mass Index (BMI)

    Time frame: Baseline

    BMI calculated from weight and height measured at baseline.Units:kg/m², Type:Continuous

  64. Household Residence

    Time frame: Baseline

    Household residence (urban/rural) recorded at baseline using structured questionnaire.Type:Categorical

  65. Annual Household Income

    Time frame: Baseline

    Annual household income recorded at baseline using structured questionnaire.Type : categorical

  66. Study Pressure Level

    Time frame: Baseline

    Self-reported level of study pressure and workload, assessed by questionnaire with four levels ranging from low to high. Variable type: Categorical.

  67. Unhealthy Visual Habits

    Time frame: Baseline

    Presence of unhealthy visual habits (e.g., reading under strong sunlight, using screens in dark environments, improper posture during near work), assessed by multiple-choice questionnaire. Variable type: Categorical (multiple response).

  68. Lighting Conditions During Nighttime Near Work

    Time frame: Baseline

    Lighting conditions used during near-work activities after dark (e.g., desk lamp, ceiling light), assessed by questionnaire. Variable type: Categorical.

  69. Moderate-to-Vigorous Physical Activity Duration

    Time frame: Baseline

    Average daily duration of moderate-to-vigorous physical activity (e.g., brisk walking, running, jumping rope, cycling) over the past week, assessed by questionnaire. Variable type: Categorical.

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial of Branched-Chain Amino Acid Supplementation for Preventing Myopia Progression

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 14, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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