RCT on the Neurobehavioral Effects of Fruits and Vegetables in Shanghai Children

NCT06560359 | Completed DMC

• 1 other identifier: HN25462
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

This project proposal outlines a randomized-controlled trial (RCT) aimed at evaluating the effects of increased fruit and vegetable (F\&V) intake on cognitive performance, attention, and mood in Chinese children aged 7-11 years. The increased F\&V intake will be achieved by providing a daily healthy breakfast including at least one piece of fruits and one piece of vegetables. The RCT includes a 2-week Lead-In term, 12 week Intervention term and 4-6 week Washout/Follow-Up term, targeting 250 children from the selected schools in Shanghai. The primary objective is to measure cognitive improvement using the Wechsler Intelligence Scale for Children (WISC-IV), while secondary outcomes will assess mood, attention, biomarkers, behavioral changes in dietary choices and the mechanism. The results of this trial may provide critical evidence on the benefits of F\&V consumption in children.

Conditions

Cognitive Function; Mood Disorders; Attention-deficit

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Performance

  The primary outcome measure will assess the change in cognitive performance of children participating in the study. This will be evaluated using the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), which is validated for use with Chinese children. The WISC-IV scale includes a range of cognitive tests that produce a Full Scale IQ score, with subtests for Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed. The scores range from 40 to 160, where higher scores indicate better cognitive performance. The measure will focus on the change in cognitive scores from baseline to post-intervention, as well as the retention of any cognitive changes after the washout period.

  the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).

Secondary Outcomes (8)

• Change in Mood States

  the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).

• Change in Attention

  the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).

• Identification of Biomarkers in Saliva, Urine, and Feces Related to Cognition, Mood, and Attention

  the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).

• Behavioral Changes in Dietary Choices Influenced by Fruit and Vegetable Intake

  the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).

• Investigation of Current Status and Barriers to Fruit and Vegetable Intake

  the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).

Study Arms (2)

Trial Group

EXPERIMENTAL

Participants in the Trial Group will receive a daily intervention consisting of a breakfast that includes one piece of fruits (e.g., an apple or a banana), vegetables (e.g., a carrot or a cucumber), and other regular diet. The fruit and vegetable will be provided as part of a standardized breakfast menu designed by nutrition experts. This intervention will be administered every morning, seven days a week, for a duration of 12 weeks. The goal is to increase the daily intake of fruits and vegetables among participants to assess the effects on cognitive performance, mood and attention.

Dietary Supplement: F&V

Control group

PLACEBO COMPARATOR

Participants in the Control Group will maintain their regular breakfast without any additional interventions related to fruit and vegetable intake. No changes will be made to their daily breakfast routine.

Dietary Supplement: No F&V

Interventions

F&V DIETARY_SUPPLEMENT

The intervention includes the healthy breakfast plan (daily delivery of balanced breakfast containing at least one piece of fruits, vegetables and other regular diet). Meals were centrally prepared by a professional catering service and delivered every morning, seven days a week, to participants' homes, ensuring consistency in portion size and quality. The selection of fruits and vegetables will consider seasonal availability to ensure freshness and variety. Nutrient density and adequacy will be monitored throughout the intervention period, with adjustments made as needed to maintain the nutritional integrity of the meals. Compliance will be tracked through daily logs and periodic assessments, ensuring that participants are consistently consuming the provided meals. This intervention is specifically designed to investigate the neurobehavioral impact of increased fruit and vegetable intake in a controlled and measurable manner.

Trial Group

No F&V DIETARY_SUPPLEMENT

The intervention only includes breakfast plan (daily delivery of balanced breakfast containing regular diet without fruits and vegetables) for 12 weeks. Meals were centrally prepared by a professional catering service and delivered every morning, seven days a week, to participants' homes, ensuring consistency in portion size and quality. Nutrient density and adequacy will be monitored throughout the intervention period, with adjustments made as needed to maintain the nutritional integrity of the meals. Compliance will be tracked through daily logs and periodic assessments, ensuring that participants are consistently consuming the provided meals. This intervention is specifically designed to investigate the neurobehavioral impact of increased fruit and vegetable intake in a controlled and measurable manner.

Control group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7-11 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

School of public health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Mood Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups (Trial group and Control group) start with 2 weeks of no F\&V, following 12 weeks of intervention, and then 4-6 weeks of washout (both groups with no intervention), this full study takes 18 weeks.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 11, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 30, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)