Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression
2026年7月9日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
104
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Jiangsu
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Nanjing、Jiangsu、中国、210096
- School of Public Health, Southeast University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in axial length
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Superficial retinal vessel density
大体时间：Baseline and 6 months
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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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Baseline and 6 months
|
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
大体时间：Baseline and 6 months
|
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
大体时间：Baseline and 6 months
|
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
大体时间：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
大体时间：Baseline and 6 months
|
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
大体时间：Baseline and 6 months
|
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
大体时间：Baseline and 6 months
|
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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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.
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Baseline and 6 months
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Total Bilirubin (TBil)
大体时间：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.
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Baseline and 6 months
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Serum Creatinine (Scr)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：Baseline and 6 months
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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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：Baseline
|
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
大体时间：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
大体时间：Baseline
|
Annual household income recorded at baseline using structured questionnaire.Type : categorical
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Baseline
|
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Study Pressure Level
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
|
Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月5日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2027年1月30日
研究注册日期
首次提交
2026年4月23日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.