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Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression

6 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

108

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
    • Jiangsu
      • Nanjing, Jiangsu, Chiny, 210009
        • Zhongda Hospital, Southeast University No. 87 Dingjiaqiao Road, Gulou District, Nanjing, Jiangsu Province, China

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Suplement diety: Branched-Chain Amino Acids (BCAA) Supplementation
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.
Inne nazwy:
  • BCAA
  • Branched-chain amino acids
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in axial length
Ramy czasowe: Baseline to 6 months
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.
Baseline to 6 months
Change in spherical equivalent refractive error
Ramy czasowe: Baseline to 6 months
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.
Baseline to 6 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Superficial retinal vessel density
Ramy czasowe: Baseline and 6 months
Superficial retinal vessel density will be measured in both eyes using OCTA in foveal, parafoveal, and perifoveal regions. Sectoral measurements (temporal, superior, nasal, and inferior) will be obtained, and the final value will be calculated as the mean of all regions, reported as a percentage (%).
Baseline and 6 months
Deep retinal vessel density
Ramy czasowe: Baseline and 6 months
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 (%).
Baseline and 6 months
Choriocapillaris perfusion density
Ramy czasowe: Baseline and 6 months
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 (%).
Baseline and 6 months
Retinal perfusion density
Ramy czasowe: Baseline and 6 months
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 (%).
Baseline and 6 months
Family Ocular History
Ramy czasowe: Baseline

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
Nutritional Supplement Use
Ramy czasowe: Baseline

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
Protein Allergy History
Ramy czasowe: Baseline

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
Parental Education Level
Ramy czasowe: Baseline
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
Baseline
Daily Screen Time
Ramy czasowe: Baseline
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.
Baseline
Eye Rest and Break Behavior
Ramy czasowe: Baseline
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).
Baseline
Sleep Duration
Ramy czasowe: Baseline
Definition: Average daily sleep duration over the past week. Variable type: Continuous Measurement: Self-reported average sleep time (hours and minutes per day).
Baseline
Staple food intake frequency
Ramy czasowe: Baseline
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.
Baseline
Protein-rich food intake frequency
Ramy czasowe: Baseline
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.
Baseline
Vegetable intake frequency
Ramy czasowe: Baseline
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.
Baseline
Fruit intake frequency
Ramy czasowe: Baseline
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.
Baseline
Dairy product intake frequency
Ramy czasowe: Baseline
Frequency and quantity of dairy product consumption, including liquid milk, milk powder, and yogurt, assessed using a semi-quantitative food frequency questionnaire.
Baseline
Snack and sugary food intake frequency
Ramy czasowe: Baseline
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.
Baseline
Temporal Superior RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary retinal nerve fiber layer (RNFL) thickness in the temporal superior (TU) sector measured by optical coherence tomography angiography (OCTA), reported in micrometers (µm).
Baseline and 6 months
Superior Temporal RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the superior temporal (ST) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Superior Nasal RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the superior nasal (SN) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Nasal Superior RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the nasal superior (NU) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Nasal Inferior RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the nasal inferior (NL) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Inferior Nasal RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the inferior nasal (IN) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Inferior Temporal RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the inferior temporal (IT) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Temporal Inferior RNFL Thickness
Ramy czasowe: Baseline and 6 months
Peripapillary RNFL thickness in the temporal inferior (TL) sector measured by OCTA, reported in micrometers (µm).
Baseline and 6 months
Global Average Peripapillary RNFL Thickness
Ramy czasowe: Baseline and 6 months
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).
Baseline and 6 months
Optic Disc Area
Ramy czasowe: Baseline and 6 months
Optic disc area measured in both eyes using optical coherence tomography angiography (OCTA), reported in square millimeters (mm²).
Baseline and 6 months
Neuroretinal Rim Area
Ramy czasowe: Baseline and 6 months
Neuroretinal rim area measured in both eyes using OCTA, reported in square millimeters (mm²).
Baseline and 6 months
Optic Cup Volume
Ramy czasowe: Baseline and 6 months
Optic cup volume measured in both eyes using OCTA, reported in cubic millimeters (mm³).
Baseline and 6 months
Cup-to-Disc Ratio
Ramy czasowe: Baseline and 6 months
Cup-to-disc ratio measured in both eyes using OCTA, defined as the ratio of optic cup diameter to optic disc diameter (unitless).
Baseline and 6 months
Vertical Cup-to-Disc Ratio
Ramy czasowe: Baseline and 6 months
Vertical cup-to-disc ratio measured in both eyes using OCTA (unitless).
Baseline and 6 months
Horizontal Cup-to-Disc Ratio
Ramy czasowe: Baseline and 6 months
Horizontal cup-to-disc ratio measured in both eyes using OCTA (unitless).
Baseline and 6 months
Peripapillary Temporal Superior Sector Vessel Density
Ramy czasowe: Baseline and 6 months
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 (%).
Baseline and 6 months
Peripapillary Superior Temporal Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the superior temporal (ST) peripapillary sector in both eyes,reported as vessel density percentage (%).
Baseline and 6 months
Peripapillary Superior Nasal Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the superior nasal (SN) peripapillary sector in both eyes,reported as vessel density percentage (%).
Baseline and 6 months
Peripapillary Nasal Superior Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the nasal superior (NU) peripapillary sector in both eyes,reported as vessel density percentage (%).
Baseline and 6 months
Peripapillary Nasal Inferior Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the nasal inferior (NL) peripapillary sector in both eyes,
Baseline and 6 months
Peripapillary Inferior Nasal Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the inferior nasal (IN) peripapillary sector in both eyes,reported as vessel density percentage (%).
Baseline and 6 months
Peripapillary Inferior Temporal Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the inferior temporal (IT) peripapillary sector in both eyes,reported as vessel density percentage (%).
Baseline and 6 months
Peripapillary Temporal Inferior Sector Vessel Density
Ramy czasowe: Baseline and 6 months
OCTA-derived vessel density in the temporal inferior (TL) peripapillary sector in both eyes,reported as vessel density percentage (%).
Baseline and 6 months
Global Peripapillary Vessel Density
Ramy czasowe: Baseline and 6 months
Mean peripapillary microvascular vessel density calculated across all peripapillary sectors in both eyes using OCTA,reported as vessel density percentage (%).
Baseline and 6 months
Full Macular Retinal Thickness
Ramy czasowe: Baseline and 6 months
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.
Baseline and 6 months
Macular Inner Retinal Layer Thickness
Ramy czasowe: Baseline and 6 months
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).
Baseline and 6 months
Macular Outer Retinal Layer Thickness
Ramy czasowe: Baseline and 6 months
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.
Baseline and 6 months
Foveal Avascular Zone Area
Ramy czasowe: Baseline and 6 months
Foveal avascular zone (FAZ) area measured in both eyes using optical coherence tomography angiography (OCTA).
Baseline and 6 months
FAZ-300 Superficial Capillary Plexus Perfusion Density
Ramy czasowe: Baseline and 6 months
Perfusion density in a 300 μm annular region surrounding the FAZ in the superficial capillary plexus measured using OCTA.
Baseline and 6 months
FAZ-300 Deep Capillary Plexus Perfusion Density
Ramy czasowe: Baseline and 6 months
Perfusion density in a 300 μm annular region surrounding the FAZ in the deep capillary plexus measured using OCTA.
Baseline and 6 months
FAZ-300 Full Retinal Perfusion Density
Ramy czasowe: Baseline and 6 months
Perfusion density in a 300 μm annular region surrounding the FAZ across full retinal layers measured using OCTA.
Baseline and 6 months
Alanine Aminotransferase (ALT)
Ramy czasowe: Baseline and 6 months
Serum alanine aminotransferase (ALT) measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Aspartate Aminotransferase (AST)
Ramy czasowe: Baseline and 6 months
Serum AST measured using standard laboratory methods in fasting venous blood. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Total Bilirubin (TBil)
Ramy czasowe: Baseline and 6 months
Serum total bilirubin measured in fasting venous blood. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Serum Creatinine (Scr)
Ramy czasowe: Baseline and 6 months
Serum creatinine measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Blood Urea Nitrogen (BUN)
Ramy czasowe: Baseline and 6 months
BUN measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Uric Acid (UA)
Ramy czasowe: Baseline and 6 months
Serum uric acid measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Fasting Plasma Glucose (FPG)
Ramy czasowe: Baseline and 6 months
Fasting plasma glucose measured in fasting venous blood using standard laboratory methods. Values will be analyzed as continuous variables and categorized as normal or abnormal based on clinical reference ranges.
Baseline and 6 months
Total Cholesterol (TC)
Ramy czasowe: Baseline and 6 months
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.
Baseline and 6 months
Triglycerides (TG)
Ramy czasowe: Baseline and 6 months
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.
Baseline and 6 months
High-Density Lipoprotein Cholesterol (HDL-C)
Ramy czasowe: Baseline and 6 months
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.
Baseline and 6 months
Low-Density Lipoprotein Cholesterol (LDL-C)
Ramy czasowe: Baseline and 6 months
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.
Baseline and 6 months
Sex of Participants
Ramy czasowe: Baseline
Participant sex recorded at baseline using structured questionnaire.
Baseline
Age of Participants
Ramy czasowe: Baseline
Age calculated from date of birth at baseline using structured questionnaire.
Baseline
Ethnicity of Participants
Ramy czasowe: Baseline
Ethnicity recorded at baseline using structured questionnaire.
Baseline
Body Mass Index (BMI)
Ramy czasowe: Baseline
BMI calculated from weight and height measured at baseline.Units：kg/m², Type：Continuous
Baseline
Household Residence
Ramy czasowe: Baseline
Household residence (urban/rural) recorded at baseline using structured questionnaire.Type：Categorical
Baseline
Annual Household Income
Ramy czasowe: Baseline
Annual household income recorded at baseline using structured questionnaire.Type : categorical
Baseline
Study Pressure Level
Ramy czasowe: Baseline
Self-reported level of study pressure and workload, assessed by questionnaire with four levels ranging from low to high. Variable type: Categorical.
Baseline
Unhealthy Visual Habits
Ramy czasowe: Baseline
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).
Baseline
Lighting Conditions During Nighttime Near Work
Ramy czasowe: Baseline
Lighting conditions used during near-work activities after dark (e.g., desk lamp, ceiling light), assessed by questionnaire. Variable type: Categorical.
Baseline
Moderate-to-Vigorous Physical Activity Duration
Ramy czasowe: Baseline
Average daily duration of moderate-to-vigorous physical activity (e.g., brisk walking, running, jumping rope, cycling) over the past week, assessed by questionnaire. Variable type: Categorical.
Baseline

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Zhongda Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 stycznia 2026

Zakończenie podstawowe (Szacowany)

30 grudnia 2026

Ukończenie studiów (Szacowany)

30 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

23 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 maja 2026

Pierwszy wysłany (Rzeczywisty)

14 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025ZDSYLL321-PO1

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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