Cognitive FunctionNCT06560359
RCT on the Neurobehavioral Effects of Fruits and Vegetables in Shanghai Children
A study testing F&V and No F&V in people with Cognitive Function and Mood Disorders, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Mood Disorders, Attention-deficit
- What is being tested?
- F&V and No F&V
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 251 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of public health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Neurobehavioral Effects of Increased Fruit and Vegetable Intake on Cognition, Mood, and Attention in 7-11-Year-Old Children From Shanghai: A Randomized Controlled Trial
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.
Read the detailed description
- Intervention Method: The intervention will be implemented through the Healthy Breakfast Plan.
- Healthy Breakfast Plan: During the 12-week intervention period, a pre-designed breakfast (including regular breakfast foods with fruits and vegetables) will be delivered daily to the homes of participating children.
- Important Considerations:
- The Breakfast Plan will include both the intervention group and the control group. The intervention group will receive the intervention meal (having fruits and vegetables), while the control group will receive a control meal (not having fruits and vegetables). ii) The nutritional composition of the Healthy Breakfast Plan will be pre-designed by experts from the Department of Nutrition and Food Hygiene at Fudan University to ensure scientific accuracy.
- Sample Size: The study will include a total of 250 children from the selected schools. Children will be randomly selected from 6 to 8 classes, resulting in approximately 125 children in the trial group and 125 in the control group. Cluster randomization will be applied at the classroom level, ensuring that all children within the same classroom are assigned to the same group. The sample size calculation is based on previous studies of literature using the Wechsler Intelligence Scale for Children (WISC-IV) to assess cognitive function. With assumptions based on existing literature, the study requires at least 150 participants to achieve statistical power. Accounting for a 20% attrition rate, a sample size of 188 is chosen to ensure robustness.
- Exposure: Biomarkers, specifically vitamin C (ascorbic acid), will be measured from urine samples to monitor the intake of fruits and vegetables. The analysis will be conducted using reverse-phase high-performance liquid chromatography (HPLC) with UV detection or ultra-performance liquid chromatography coupled with mass spectrometry (UPLC-MS/MS).
- Quality Control: To ensure accuracy in dietary intake reporting, the study will utilize food frequency questionnaires and 24-hour dietary records. These tools will help monitor and validate the children's fruit and vegetable consumption throughout the intervention period.
- Ensuring Compliance with Fruit and Vegetable Intake:
- Vitamin C Measurement: Urinary vitamin C levels will be measured to verify actual fruit and vegetable intake.
- Questionnaires: Supervision of intake will be supported by questionnaires designed to track compliance and dietary habits.
- Online Management Software: The study will use online management software to document each aspect of the project, allowing the research team and supervisors to monitor progress in real-time.
- Data Collection and Assessments: (a) Survey Questionnaires: i) Cognition: Evaluated by Wechsler Intelligence Scale for Children (WISC-IV). ii) Mood: Evaluated using the Profile of Mood States (POMS) questionnaire. iii) Attention: Evaluated by the Conners Parent Symptom Questionnaire (PSQ). iv) Physical Activity: Assessed using the International Physical Activity Questionnaire (IPAQ).
- Dietary Habits and Preferences: Assessed by Food Frequency Questionnaire (FFQ), 24-hour dietary records, and the food preference questionnaires. vi) A computerized food choice/preference task: Behavioral assessment battery. (b) Biological Specimen Collection: i) Urine sample: for measuring vitamin C. ii) Saliva sample: for measuring cortisol. Saliva sample will be collected from a subpopulation as a pilot study. iii) Feces: for exploring the gut mechanisms that may modify the neurobehavior effects by increased intake of fruits and vegetables. Feces sample will be collected from a subpopulation as a pilot study. (c) Physical Examinations: i) Measurements of height, weight, waist-to-hip ratio, and skinfold thickness will be taken to assess the overall physical health of participants. (d) Subgroup of participants i) An exploratory mechanistic neuroimaging substudy in which functional near-infrared spectroscopy (fNIRS) was used during the food choice/preference task to assess cortical activation associated with food-related decision-making.
- Conditions
- Cognitive Function, Mood Disorders, Attention-deficit
- Being tested
- F&V, No F&V
- Medical subject headings
- Mood Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F&VDietary 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.
No F&VDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: No F&V |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
Secondary outcomes (8)
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).
Measured: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
Mechanistic Study of Cognitive Effects through Gut Microbiota
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.
Measured: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
Behavioral responses on food choice/preference task
Behavioral responses on a computerized food choice/preference task, including task-based food selections and preference-related responses, assessed to examine whether the intervention was associated with changes in food-related decision-making.
Measured: End of Week 2 (Baseline), Week 14 (end of intervention)
Cortical activation assessed by fNIRS during food choice/preference task in a voluntary subgroup
In a voluntary subgroup of participants who agreed to undergo additional neuroimaging assessment, functional near-infrared spectroscopy (fNIRS) was used to measure cortical activation during the computerized food choice/preference task to explore neural responses related to food-related decision-making.
Measured: End of Week 2 (Baseline) and Week 14 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start11 Sep 2024
- Primary completion28 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560359
- Sponsor's protocol ID
- HN25462
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Effects of Increased Fruit and Vegetable Intake on Cognition, Mood, and Attention in 7-11-Year-Old Children From Shanghai: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06560359
- Acronym / sponsor ID
- HN25462
- Conditions
- Cognitive Function, Mood Disorders, Attention-deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Intervention Method: The intervention will be implemented through the Healthy Breakfast Plan.
- Healthy Breakfast Plan: During the 12-week intervention period, a pre-designed breakfast (including regular breakfast foods with fruits and vegetables) will be delivered daily to the homes of participating children.
- Important Considerations:
- The Breakfast Plan will include both the intervention group and the control group. The intervention group will receive the intervention meal (having fruits and vegetables), while the control group will receive a control meal (not having fruits and vegetables). ii) The nutritional composition of the Healthy Breakfast Plan will be pre-designed by experts from the Department of Nutrition and Food Hygiene at Fudan University to ensure scientific accuracy.
- Sample Size: The study will include a total of 250 children from the selected schools. Children will be randomly selected from 6 to 8 classes, resulting in approximately 125 children in the trial group and 125 in the control group. Cluster randomization will be applied at the classroom level, ensuring that all children within the same classroom are assigned to the same group. The sample size calculation is based on previous studies of literature using the Wechsler Intelligence Scale for Children (WISC-IV) to assess cognitive function. With assumptions based on existing literature, the study requires at least 150 participants to achieve statistical power. Accounting for a 20% attrition rate, a sample size of 188 is chosen to ensure robustness.
- Exposure: Biomarkers, specifically vitamin C (ascorbic acid), will be measured from urine samples to monitor the intake of fruits and vegetables. The analysis will be conducted using reverse-phase high-performance liquid chromatography (HPLC) with UV detection or ultra-performance liquid chromatography coupled with mass spectrometry (UPLC-MS/MS).
- Quality Control: To ensure accuracy in dietary intake reporting, the study will utilize food frequency questionnaires and 24-hour dietary records. These tools will help monitor and validate the children's fruit and vegetable consumption throughout the intervention period.
- Ensuring Compliance with Fruit and Vegetable Intake:
- Vitamin C Measurement: Urinary vitamin C levels will be measured to verify actual fruit and vegetable intake.
- Questionnaires: Supervision of intake will be supported by questionnaires designed to track compliance and dietary habits.
- Online Management Software: The study will use online management software to document each aspect of the project, allowing the research team and supervisors to monitor progress in real-time.
- Data Collection and Assessments: (a) Survey Questionnaires: i) Cognition: Evaluated by Wechsler Intelligence Scale for Children (WISC-IV). ii) Mood: Evaluated using the Profile of Mood States (POMS) questionnaire. iii) Attention: Evaluated by the Conners Parent Symptom Questionnaire (PSQ). iv) Physical Activity: Assessed using the International Physical Activity Questionnaire (IPAQ).
- Dietary Habits and Preferences: Assessed by Food Frequency Questionnaire (FFQ), 24-hour dietary records, and the food preference questionnaires. vi) A computerized food choice/preference task: Behavioral assessment battery. (b) Biological Specimen Collection: i) Urine sample: for measuring vitamin C. ii) Saliva sample: for measuring cortisol. Saliva sample will be collected from a subpopulation as a pilot study. iii) Feces: for exploring the gut mechanisms that may modify the neurobehavior effects by increased intake of fruits and vegetables. Feces sample will be collected from a subpopulation as a pilot study. (c) Physical Examinations: i) Measurements of height, weight, waist-to-hip ratio, and skinfold thickness will be taken to assess the overall physical health of participants. (d) Subgroup of participants i) An exploratory mechanistic neuroimaging substudy in which functional near-infrared spectroscopy (fNIRS) was used during the food choice/preference task to assess cortical activation associated with food-related decision-making.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Dietary Supplement: F&VParticipants 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. |
| Control group | Placebo comparator | Dietary Supplement: No F&VParticipants 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F&VThe 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 | Trial Group |
| No F&VThe 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. | Dietary supplement | Control group |
Primary outcome
Change in Cognitive Performance
Time frame: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
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.
8 secondary outcomes
Change in Mood States
Time frame: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
Change in Attention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
Mechanistic Study of Cognitive Effects through Gut Microbiota
Time frame: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).
Behavioral responses on food choice/preference task
Time frame: End of Week 2 (Baseline), Week 14 (end of intervention)
Cortical activation assessed by fNIRS during food choice/preference task in a voluntary subgroup
Time frame: End of Week 2 (Baseline) and Week 14 (end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F&V and No F&V in people with Cognitive Function and Mood Disorders, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Performance (time frame: the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18-20 (post-washout).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.