Myopia ProgressingNCT07585877
Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression
A study testing Branched-Chain Amino Acids (BCAA) Supplementation in people with Myopia Progressing and Myopia, run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia Progressing, Myopia
- What is being tested?
- Branched-Chain Amino Acids (BCAA) Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 30 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Public Health, Southeast University
Nanjing, Jiangsu, 210096
About this study
Official title: A Randomized Controlled Trial of Branched-Chain Amino Acid Supplementation for Preventing 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.
Read more
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
- Being tested
- Branched-Chain Amino Acids (BCAA) Supplementation
- Keywords
- Myopia Progression, Branched-chain amino acids, Nutritional supplementation, Randomized controlled trial, Axial length, OCTA
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched-Chain Amino Acids (BCAA) SupplementationDietary supplement
Also called BCAA, Branched-chain amino acids
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 months
Secondary outcomes (69)
Superficial retinal vessel density
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 (%).
Measured: Baseline and 6 months
Deep retinal vessel density
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 (%).
Measured: Baseline and 6 months
Choriocapillaris perfusion density
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 (%).
Measured: Baseline and 6 months
Retinal perfusion density
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 (%).
Measured: Baseline and 6 months
Family Ocular History
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°).
Measured: Baseline
Nutritional Supplement Use
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).
Measured: Baseline
Protein Allergy History
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).
Measured: Baseline
Parental Education Level
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
Measured: Baseline
Daily Screen Time
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.
Measured: Baseline
Eye Rest and Break Behavior
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).
Measured: Baseline
Sleep Duration
Definition: Average daily sleep duration over the past week. Variable type: Continuous Measurement: Self-reported average sleep time (hours and minutes per day).
Measured: Baseline
Staple food intake frequency
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.
Measured: Baseline
Protein-rich food intake frequency
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.
Measured: Baseline
Vegetable intake frequency
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.
Measured: Baseline
Fruit intake frequency
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.
Measured: Baseline
Dairy product intake frequency
Frequency and quantity of dairy product consumption, including liquid milk, milk powder, and yogurt, assessed using a semi-quantitative food frequency questionnaire.
Measured: Baseline
Snack and sugary food intake frequency
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.
Measured: Baseline
Temporal Superior RNFL Thickness
Peripapillary retinal nerve fiber layer (RNFL) thickness in the temporal superior (TU) sector measured by optical coherence tomography angiography (OCTA), reported in micrometers (µm).
Measured: Baseline and 6 months
Superior Temporal RNFL Thickness
Peripapillary RNFL thickness in the superior temporal (ST) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Superior Nasal RNFL Thickness
Peripapillary RNFL thickness in the superior nasal (SN) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Nasal Superior RNFL Thickness
Peripapillary RNFL thickness in the nasal superior (NU) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Nasal Inferior RNFL Thickness
Peripapillary RNFL thickness in the nasal inferior (NL) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Inferior Nasal RNFL Thickness
Peripapillary RNFL thickness in the inferior nasal (IN) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Inferior Temporal RNFL Thickness
Peripapillary RNFL thickness in the inferior temporal (IT) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Temporal Inferior RNFL Thickness
Peripapillary RNFL thickness in the temporal inferior (TL) sector measured by OCTA, reported in micrometers (µm).
Measured: Baseline and 6 months
Global Average Peripapillary RNFL Thickness
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).
Measured: Baseline and 6 months
Optic Disc Area
Optic disc area measured in both eyes using optical coherence tomography angiography (OCTA), reported in square millimeters (mm²).
Measured: Baseline and 6 months
Neuroretinal Rim Area
Neuroretinal rim area measured in both eyes using OCTA, reported in square millimeters (mm²).
Measured: Baseline and 6 months
Optic Cup Volume
Optic cup volume measured in both eyes using OCTA, reported in cubic millimeters (mm³).
Measured: Baseline and 6 months
Cup-to-Disc Ratio
Cup-to-disc ratio measured in both eyes using OCTA, defined as the ratio of optic cup diameter to optic disc diameter (unitless).
Measured: Baseline and 6 months
Vertical Cup-to-Disc Ratio
Vertical cup-to-disc ratio measured in both eyes using OCTA (unitless).
Measured: Baseline and 6 months
Horizontal Cup-to-Disc Ratio
Horizontal cup-to-disc ratio measured in both eyes using OCTA (unitless).
Measured: Baseline and 6 months
Peripapillary Temporal Superior Sector Vessel Density
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 (%).
Measured: Baseline and 6 months
Peripapillary Superior Temporal Sector Vessel Density
OCTA-derived vessel density in the superior temporal (ST) peripapillary sector in both eyes,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Peripapillary Superior Nasal Sector Vessel Density
OCTA-derived vessel density in the superior nasal (SN) peripapillary sector in both eyes,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Peripapillary Nasal Superior Sector Vessel Density
OCTA-derived vessel density in the nasal superior (NU) peripapillary sector in both eyes,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Peripapillary Nasal Inferior Sector Vessel Density
OCTA-derived vessel density in the nasal inferior (NL) peripapillary sector in both eyes,
Measured: Baseline and 6 months
Peripapillary Inferior Nasal Sector Vessel Density
OCTA-derived vessel density in the inferior nasal (IN) peripapillary sector in both eyes,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Peripapillary Inferior Temporal Sector Vessel Density
OCTA-derived vessel density in the inferior temporal (IT) peripapillary sector in both eyes,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Peripapillary Temporal Inferior Sector Vessel Density
OCTA-derived vessel density in the temporal inferior (TL) peripapillary sector in both eyes,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Global Peripapillary Vessel Density
Mean peripapillary microvascular vessel density calculated across all peripapillary sectors in both eyes using OCTA,reported as vessel density percentage (%).
Measured: Baseline and 6 months
Full Macular Retinal Thickness
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.
Measured: Baseline and 6 months
Macular Inner Retinal Layer Thickness
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).
Measured: Baseline and 6 months
Macular Outer Retinal Layer Thickness
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.
Measured: Baseline and 6 months
Foveal Avascular Zone Area
Foveal avascular zone (FAZ) area measured in both eyes using optical coherence tomography angiography (OCTA).
Measured: Baseline and 6 months
FAZ-300 Superficial Capillary Plexus Perfusion Density
Perfusion density in a 300 μm annular region surrounding the FAZ in the superficial capillary plexus measured using OCTA.
Measured: Baseline and 6 months
FAZ-300 Deep Capillary Plexus Perfusion Density
Perfusion density in a 300 μm annular region surrounding the FAZ in the deep capillary plexus measured using OCTA.
Measured: Baseline and 6 months
FAZ-300 Full Retinal Perfusion Density
Perfusion density in a 300 μm annular region surrounding the FAZ across full retinal layers measured using OCTA.
Measured: Baseline and 6 months
Alanine Aminotransferase (ALT)
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.
Measured: Baseline and 6 months
Aspartate Aminotransferase (AST)
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.
Measured: Baseline and 6 months
Total Bilirubin (TBil)
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.
Measured: Baseline and 6 months
Serum Creatinine (Scr)
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.
Measured: Baseline and 6 months
Blood Urea Nitrogen (BUN)
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.
Measured: Baseline and 6 months
Uric Acid (UA)
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.
Measured: Baseline and 6 months
Fasting Plasma Glucose (FPG)
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.
Measured: Baseline and 6 months
Total Cholesterol (TC)
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.
Measured: Baseline and 6 months
Triglycerides (TG)
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.
Measured: Baseline and 6 months
High-Density Lipoprotein Cholesterol (HDL-C)
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.
Measured: Baseline and 6 months
Low-Density Lipoprotein Cholesterol (LDL-C)
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.
Measured: Baseline and 6 months
Sex of Participants
Participant sex recorded at baseline using structured questionnaire.
Measured: Baseline
Age of Participants
Age calculated from date of birth at baseline using structured questionnaire.
Measured: Baseline
Ethnicity of Participants
Ethnicity recorded at baseline using structured questionnaire.
Measured: Baseline
Body Mass Index (BMI)
BMI calculated from weight and height measured at baseline.Units：kg/m², Type：Continuous
Measured: Baseline
Household Residence
Household residence (urban/rural) recorded at baseline using structured questionnaire.Type：Categorical
Measured: Baseline
Annual Household Income
Annual household income recorded at baseline using structured questionnaire.Type : categorical
Measured: Baseline
Study Pressure Level
Self-reported level of study pressure and workload, assessed by questionnaire with four levels ranging from low to high. Variable type: Categorical.
Measured: Baseline
Unhealthy Visual Habits
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).
Measured: Baseline
Lighting Conditions During Nighttime Near Work
Lighting conditions used during near-work activities after dark (e.g., desk lamp, ceiling light), assessed by questionnaire. Variable type: Categorical.
Measured: Baseline
Moderate-to-Vigorous Physical Activity Duration
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start5 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weina Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585877
- Sponsor's protocol ID
- 2025ZDSYLL321-PO1
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No