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A randomized, double-blind, carbon water controlled, single center evaluation of the improvement and tolerability of high protein beverages supplemented with walnut peptide and phosphatidylserine in Chinese children with attention deficit disorder aged 6-16 years: an exploratory real-world study

A randomized, double-blind, carbon water controlled, single center evaluation of the improvement and tolerability of high protein beverages supplemented with walnut peptide and phosphatidylserine in Chinese children with attention deficit disorder aged 6-16 years: an exploratory real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075133
Enrollment
Unknown
Registered
2023-08-25
Start date
2023-08-22
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit disorder in children

Interventions

control group:Add 2 spoons (about 20g) of the reference product (carbohydrates) to a cup, then pour in warm or cold water (about 250ml), and stir evenly. Suggest consuming it with breakfast or at a fi
Test group:Add 2 spoons (approximately 20g) of the test product (a high protein beverage with walnuts peptide and phosphatidylserine added) to a cup, then pour in warm or cold water (approximately 250

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. The subject and their guardians agree to participate in the experiment and have obtained signed and dated informed consent from one guardian and, as appropriate, from the subject; 2. Age range from 6 to 16 years old (including 6 and 16 years old), regardless of gender; 3.According to the Fifth Edition of the Diagnostic and Statistical Manual for Mental Disorders in the United States (DSM-5), researchers have diagnosed attention deficit and do not require medication.

Exclusion criteria

Exclusion criteria: 1. Allergy to the ingredients in the test food products and preparations, allergic constitution, or history of allergies to multiple drugs; 2. Have taken other protein powder products, as well as dietary supplements or drugs containing walnut peptide and phosphatidylserine within the past 6 months (based on the product manual); According to the "overweight and obesity screening for school-age children and adolescents", the Body Mass Index (BMI) belongs to obesity. 4. There have been uncontrolled active bacterial, viral, fungal, Rickettsia, or parasitic infections that require systematic treatment within the past month and screening period; 5. Participate in any other research involving products under study or already on the market at the same time or within 4 weeks before entering the study. 6. The researcher determined that it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
ADHD-IV Parental Rating Scale;

Secondary

MeasureTime frame
ADHD-IV Parental Rating Scale;ADHD-IV Parent Rating Scale Domain Score (Attention Deficit Scale Score and Hyperactivity Impulse Scale Score);Strengths and Difficulties Questionnaire (SDQ);Strengths and Difficulties Questionnaire (SDQ);DST;

Countries

China

Contacts

Public ContactFeng Yi

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

kcb009@163.com+86 138 1707 2680

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026