Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression
2026. július 9. frissítette: 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.
A tanulmány áttekintése
Állapot
Aktív, nem toborzó
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
104
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Jiangsu
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Nanjing, Jiangsu, Kína, 210096
- School of Public Health, Southeast University
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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.
Más nevek:
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Nincs beavatkozás: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in axial length
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Superficial retinal vessel density
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2026. január 5.
Elsődleges befejezés (Becsült)
2026. december 30.
A tanulmány befejezése (Becsült)
2027. január 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. április 23.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. május 6.
Első közzététel (Tényleges)
2026. május 14.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. július 13.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 9.
Utolsó ellenőrzés
2026. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2025ZDSYLL321-PO1
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .