RCT on the Neurobehavioral Effects of Fruits and Vegetables in Shanghai Children
NCT Number: NCT06560359
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Function|Mood Disorders|Attention-deficit
Interventions: DIETARY_SUPPLEMENT: F&V|DIETARY_SUPPLEMENT: No F&V
Sponsor: Fudan University
Sex: ALL
Age: CHILD
Enrollment: 280
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2025-04-20

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 8-10 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, as will as a weekly fruit box. The RCT includes a 2-week Lead-In term, 12 week Intervention term and 4 week Washout/Follow-Up term, targeting 280 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.

Primary Outcome Measures: 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 (post-washout).
Secondary Outcome Measures: Change in Mood States, This outcome will measure the change in mood states among participants, using the Profile of Mood States (POMS) questionnaire, which is validated for use in Chinese children. The POMS questionnaire assesses various aspects of mood, including tension, depression, anger, vigor, fatigue, and confusion. The scores for each mood state range from 0 to 4, with higher scores indicating a worse outcome in negative mood states (tension, depression, anger, fatigue, and confusion) and a better outcome in the positive mood state (vigor)., the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout).|Change in Attention, This outcome will assess changes in attention among participants, as perceived by their parents, using the Conners' Parent Rating Scale (CPRS), which is also referred to in some contexts as the Conners Parent Symptom Questionnaire (PSQ). The CPRS is a validated tool used in the Chinese population to evaluate behavioral concerns, including attention. The scale includes items rated on a 4-point Likert scale, with scores ranging from 0 (Not at all true) to 3 (Very much true). Higher scores indicating worse attention outcomes, i.e., more attention-related problems., the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout).|Mechanistic Study of Cognitive Effects through Gut Microbiota and Portable Near-Infrared Spectroscopy, This outcome will only be measured in a subpopulation as a pilot study, which will will investigate the mechanisms by which increased fruit and vegetable intake influences cognitive function. The study will assess changes in gut microbiota composition through stool samples and examine brain activity using portable near-infrared spectroscopy to identify neural correlates of cognitive improvements., the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout).|Identification of Biomarkers in Saliva, Urine, and Feces Related to Cognition, Mood, and Attention, Vitamin C in urine will be served as a biomarker of F\&V intake. The biomarkers in saliva and feces will be served as the indicators of cognitive function, mood states, or attention levels. Samples of saliva and feces will be collected in a subpopulation as a pilot study. These biomarkers will be analyzed to understand the physiological changes associated with increased fruit and vegetable intake., the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout).|Behavioral Changes in Dietary Choices Influenced by Fruit and Vegetable Intake, This outcome will evaluate how increased intake of fruits and vegetables impacts dietary behavior, specifically the choices participants make regarding their overall diet. The assessment will be conducted using validated questionnaires that capture changes in dietary habits and preferences., the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout).|Investigation of Current Status and Barriers to Fruit and Vegetable Intake, This objective aims to assess the current level of fruit and vegetable intake among children and identify the barriers that limit their consumption. Factors such as nutrition literacy, food accessibility, and socioeconomic status will be explored to understand the challenges and opportunities for improving F\&V intake in this population., the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout).