Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression
2026年5月6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.
調査の概要
研究の種類
介入
入学 (推定)
108
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210009
- Zhongda Hospital, Southeast University No. 87 Dingjiaqiao Road, Gulou District, Nanjing, Jiangsu Province, China
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in axial length
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Superficial retinal vessel density
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Baseline and 6 months
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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)
時間枠：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)
時間枠：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)
時間枠：Baseline and 6 months
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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)
時間枠：Baseline and 6 months
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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)
時間枠：Baseline and 6 months
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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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：Baseline
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Household residence (urban/rural) recorded at baseline using structured questionnaire.Type：Categorical
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Baseline
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Annual Household Income
時間枠：Baseline
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Annual household income recorded at baseline using structured questionnaire.Type : categorical
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Baseline
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Study Pressure Level
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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Baseline
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月5日
一次修了 (推定)
2026年12月30日
研究の完了 (推定)
2027年1月30日
試験登録日
最初に提出
2026年4月23日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月6日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。