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

NCT06560359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2026-04-17

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

F&V

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.

DIETARY_SUPPLEMENT

No F&V

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2025-03-28
Completion
2025-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06560359 on ClinicalTrials.gov