Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression
6 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
108
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Jiangsu
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Nanjing, Jiangsu, Cina, 210009
- Zhongda Hospital, Southeast University No. 87 Dingjiaqiao Road, Gulou District, Nanjing, Jiangsu Province, China
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in axial length
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Superficial retinal vessel density
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
5 gennaio 2026
Completamento primario (Stimato)
30 dicembre 2026
Completamento dello studio (Stimato)
30 gennaio 2027
Date di iscrizione allo studio
Primo inviato
23 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
6 maggio 2026
Primo Inserito (Effettivo)
14 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025ZDSYLL321-PO1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .