Effects of fruits and vegetables on cognitive function in children
Neurobehavioral Effects of Increased Fruit and Vegetable Intake on Cognition, Mood, and Attention in 8-10-Year-Old Children from Shanghai: a Randomized Controlled Trial
NA · Fudan University · NCT06560359
This study is testing if giving kids aged 8-10 more fruits and vegetables in their diet can help them think better, feel happier, and pay more attention.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 8 Years to 10 Years |
| Sex | All |
| Sponsor | Fudan University (other) |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06560359 on ClinicalTrials.gov |
What this trial studies
This trial evaluates how increasing fruit and vegetable intake affects cognitive performance, mood, and attention in children aged 8-10 years in Shanghai. Participants will receive a daily healthy breakfast that includes fruits and vegetables, along with a weekly fruit box. The study will involve a 2-week lead-in, a 12-week intervention, and a 4-week follow-up period, targeting 280 children from selected schools. Cognitive improvements will be measured using the Wechsler Intelligence Scale for Children (WISC-IV), while secondary outcomes will assess mood, attention, and dietary behaviors.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-10 years who are enrolled in participating schools and can consume the provided meals.
Not a fit: Children with known allergies to the provided fruits and vegetables or diagnosed psychological or gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that increased fruit and vegetable consumption improves cognitive function and mood in children.
How similar studies have performed: While there is some evidence supporting the benefits of dietary interventions on cognitive function, this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 8-10 years. * Participants must be students enrolled in the selected schools participating in the study. * Willingness and ability to consume the provided daily breakfast, including one piece of fruit and one piece of vegetable. * Parents or legal guardians must provide informed consent for participation. * Balanced preliminary investigation outcomes, especially regarding behaviors related to fruit and vegetable intake, socioeconomic status (SES), and absence of diagnosed diseases that could impact the study. Exclusion Criteria: * Known allergies to any fruits, vegetables, or other foods provided in the intervention. * Diagnosed psychological disorders, diabetes, gastrointestinal diseases, or other conditions that might interfere with cognitive assessments or the ability to participate in the study. * Children currently participating in other dietary or cognitive intervention studies. * Inability or unwillingness to comply with study protocols, including dietary requirements and sample collection.
Where this trial is running
Shanghai, Shanghai
- School of public health, Fudan University — Shanghai, Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Bo Chen
- Email: chenb@fudan.edu.cn
- Phone: 86-21-54237146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cognitive Function, Mood Disorders, Attention-deficit