Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression
6 de maio de 2026 atualizado por: Weina Liu, Zhongda Hospital
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.
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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
108
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Southeast University No. 87 Dingjiaqiao Road, Gulou District, Nanjing, Jiangsu Province, China
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: BCAA Supplementation Group
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.
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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.
Outros nomes:
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Sem intervenção: Control Group
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in axial length
Prazo: Baseline to 6 months
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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.
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Baseline to 6 months
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Change in spherical equivalent refractive error
Prazo: Baseline to 6 months
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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.
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Baseline to 6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Superficial retinal vessel density
Prazo: 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 (%).
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Baseline and 6 months
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Deep retinal vessel density
Prazo: Baseline and 6 months
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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 (%).
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Baseline and 6 months
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Choriocapillaris perfusion density
Prazo: Baseline and 6 months
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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 (%).
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Baseline and 6 months
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Retinal perfusion density
Prazo: Baseline and 6 months
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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 (%).
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Baseline and 6 months
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Family Ocular History
Prazo: Baseline
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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°). |
Baseline
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Nutritional Supplement Use
Prazo: Baseline
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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). |
Baseline
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Protein Allergy History
Prazo: Baseline
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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). |
Baseline
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Parental Education Level
Prazo: Baseline
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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
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Baseline
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Daily Screen Time
Prazo: Baseline
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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.
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Baseline
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Eye Rest and Break Behavior
Prazo: Baseline
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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).
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Baseline
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Sleep Duration
Prazo: Baseline
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Definition: Average daily sleep duration over the past week.
Variable type: Continuous Measurement: Self-reported average sleep time (hours and minutes per day).
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Baseline
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Staple food intake frequency
Prazo: Baseline
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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.
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Baseline
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Protein-rich food intake frequency
Prazo: Baseline
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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.
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Baseline
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Vegetable intake frequency
Prazo: Baseline
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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.
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Baseline
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Fruit intake frequency
Prazo: Baseline
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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.
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Baseline
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Dairy product intake frequency
Prazo: Baseline
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Frequency and quantity of dairy product consumption, including liquid milk, milk powder, and yogurt, assessed using a semi-quantitative food frequency questionnaire.
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Baseline
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Snack and sugary food intake frequency
Prazo: Baseline
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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.
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Baseline
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Temporal Superior RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary retinal nerve fiber layer (RNFL) thickness in the temporal superior (TU) sector measured by optical coherence tomography angiography (OCTA), reported in micrometers (µm).
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Baseline and 6 months
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Superior Temporal RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the superior temporal (ST) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Superior Nasal RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the superior nasal (SN) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Nasal Superior RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the nasal superior (NU) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Nasal Inferior RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the nasal inferior (NL) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Inferior Nasal RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the inferior nasal (IN) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Inferior Temporal RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the inferior temporal (IT) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Temporal Inferior RNFL Thickness
Prazo: Baseline and 6 months
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Peripapillary RNFL thickness in the temporal inferior (TL) sector measured by OCTA, reported in micrometers (µm).
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Baseline and 6 months
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Global Average Peripapillary RNFL Thickness
Prazo: Baseline and 6 months
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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).
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Baseline and 6 months
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Optic Disc Area
Prazo: Baseline and 6 months
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Optic disc area measured in both eyes using optical coherence tomography angiography (OCTA), reported in square millimeters (mm²).
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Baseline and 6 months
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Neuroretinal Rim Area
Prazo: Baseline and 6 months
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Neuroretinal rim area measured in both eyes using OCTA, reported in square millimeters (mm²).
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Baseline and 6 months
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Optic Cup Volume
Prazo: Baseline and 6 months
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Optic cup volume measured in both eyes using OCTA, reported in cubic millimeters (mm³).
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Baseline and 6 months
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Cup-to-Disc Ratio
Prazo: Baseline and 6 months
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Cup-to-disc ratio measured in both eyes using OCTA, defined as the ratio of optic cup diameter to optic disc diameter (unitless).
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Baseline and 6 months
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Vertical Cup-to-Disc Ratio
Prazo: Baseline and 6 months
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Vertical cup-to-disc ratio measured in both eyes using OCTA (unitless).
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Baseline and 6 months
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Horizontal Cup-to-Disc Ratio
Prazo: Baseline and 6 months
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Horizontal cup-to-disc ratio measured in both eyes using OCTA (unitless).
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Baseline and 6 months
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Peripapillary Temporal Superior Sector Vessel Density
Prazo: Baseline and 6 months
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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 (%).
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Baseline and 6 months
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Peripapillary Superior Temporal Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the superior temporal (ST) peripapillary sector in both eyes,reported as vessel density percentage (%).
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Baseline and 6 months
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Peripapillary Superior Nasal Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the superior nasal (SN) peripapillary sector in both eyes,reported as vessel density percentage (%).
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Baseline and 6 months
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Peripapillary Nasal Superior Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the nasal superior (NU) peripapillary sector in both eyes,reported as vessel density percentage (%).
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Baseline and 6 months
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Peripapillary Nasal Inferior Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the nasal inferior (NL) peripapillary sector in both eyes,
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Baseline and 6 months
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Peripapillary Inferior Nasal Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the inferior nasal (IN) peripapillary sector in both eyes,reported as vessel density percentage (%).
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Baseline and 6 months
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Peripapillary Inferior Temporal Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the inferior temporal (IT) peripapillary sector in both eyes,reported as vessel density percentage (%).
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Baseline and 6 months
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Peripapillary Temporal Inferior Sector Vessel Density
Prazo: Baseline and 6 months
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OCTA-derived vessel density in the temporal inferior (TL) peripapillary sector in both eyes,reported as vessel density percentage (%).
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Baseline and 6 months
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Global Peripapillary Vessel Density
Prazo: Baseline and 6 months
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Mean peripapillary microvascular vessel density calculated across all peripapillary sectors in both eyes using OCTA,reported as vessel density percentage (%).
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Baseline and 6 months
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Full Macular Retinal Thickness
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Macular Inner Retinal Layer Thickness
Prazo: Baseline and 6 months
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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).
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Baseline and 6 months
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Macular Outer Retinal Layer Thickness
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Foveal Avascular Zone Area
Prazo: Baseline and 6 months
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Foveal avascular zone (FAZ) area measured in both eyes using optical coherence tomography angiography (OCTA).
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Baseline and 6 months
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FAZ-300 Superficial Capillary Plexus Perfusion Density
Prazo: Baseline and 6 months
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Perfusion density in a 300 μm annular region surrounding the FAZ in the superficial capillary plexus measured using OCTA.
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Baseline and 6 months
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FAZ-300 Deep Capillary Plexus Perfusion Density
Prazo: Baseline and 6 months
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Perfusion density in a 300 μm annular region surrounding the FAZ in the deep capillary plexus measured using OCTA.
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Baseline and 6 months
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FAZ-300 Full Retinal Perfusion Density
Prazo: Baseline and 6 months
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Perfusion density in a 300 μm annular region surrounding the FAZ across full retinal layers measured using OCTA.
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Baseline and 6 months
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Alanine Aminotransferase (ALT)
Prazo: 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.
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Baseline and 6 months
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Aspartate Aminotransferase (AST)
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Total Bilirubin (TBil)
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Serum Creatinine (Scr)
Prazo: 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.
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Baseline and 6 months
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Blood Urea Nitrogen (BUN)
Prazo: 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.
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Baseline and 6 months
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Uric Acid (UA)
Prazo: 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.
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Baseline and 6 months
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Fasting Plasma Glucose (FPG)
Prazo: 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.
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Baseline and 6 months
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Total Cholesterol (TC)
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Triglycerides (TG)
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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High-Density Lipoprotein Cholesterol (HDL-C)
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Low-Density Lipoprotein Cholesterol (LDL-C)
Prazo: Baseline and 6 months
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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.
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Baseline and 6 months
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Sex of Participants
Prazo: Baseline
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Participant sex recorded at baseline using structured questionnaire.
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Baseline
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Age of Participants
Prazo: Baseline
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Age calculated from date of birth at baseline using structured questionnaire.
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Baseline
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Ethnicity of Participants
Prazo: Baseline
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Ethnicity recorded at baseline using structured questionnaire.
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Baseline
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Body Mass Index (BMI)
Prazo: Baseline
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BMI calculated from weight and height measured at baseline.Units：kg/m², Type：Continuous
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Baseline
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Household Residence
Prazo: Baseline
|
Household residence (urban/rural) recorded at baseline using structured questionnaire.Type：Categorical
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Baseline
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Annual Household Income
Prazo: Baseline
|
Annual household income recorded at baseline using structured questionnaire.Type : categorical
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Baseline
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Study Pressure Level
Prazo: Baseline
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Self-reported level of study pressure and workload, assessed by questionnaire with four levels ranging from low to high.
Variable type: Categorical.
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Baseline
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Unhealthy Visual Habits
Prazo: Baseline
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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).
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Baseline
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Lighting Conditions During Nighttime Near Work
Prazo: Baseline
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Lighting conditions used during near-work activities after dark (e.g., desk lamp, ceiling light), assessed by questionnaire.
Variable type: Categorical.
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Baseline
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Moderate-to-Vigorous Physical Activity Duration
Prazo: Baseline
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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.
|
Baseline
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
5 de janeiro de 2026
Conclusão Primária (Estimado)
30 de dezembro de 2026
Conclusão do estudo (Estimado)
30 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
23 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de maio de 2026
Primeira postagem (Real)
14 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de maio de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025ZDSYLL321-PO1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .