Metabolic HealthNCT06628401
Comparing Approaches to Increasing Fruit and Vegetable Intake and Their Influence on Metabolic Health
A study testing Educational information (Increasing F&V intake) and Educational information (Increasing F&V intake + Juice) in people with Metabolic Health and Fruit and Vegetable Intake, run by Courtney Neal at 1 site in United Kingdom.
Trial summary
This experimental study aims to evaluate the effects of different strategies for increasing fruit and vegetable intake and to see how these interventions influence markers of health in people aged 18-65 who currently consume fewer than 2 portions of fruit and vegetables a day. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health, Fruit and Vegetable Intake
- What is being tested?
- Educational information (Increasing F&V intake) and Educational information (Increasing F&V intake + Juice)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2024to 5 Sep 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 - 65 years
- Currently consuming ≤2 portions of fruit and vegetables per day
Who cannot join
- Using high-dose vitamins, minerals or dietary supplements that could interfere with biomarker assessment of fruit and vegetable consumption
- Have a food sensitivity, allergy or other dietary restriction (e.g., following a weight loss diet) that would limit the ability to take part in the study
- Have a medical condition (e.g., diabetes or gastrointestinal disorders) that would limit the ability to take part in the study
- Currently pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE2 4HH
About this study
Official title: A Comparison Between Different Approaches to Increase Fruit and Vegetable Intake and Influence Markers of Metabolic Health in Humans
This experimental study aims to evaluate the effects of different strategies for increasing fruit and vegetable intake and to see how these interventions influence markers of health in people aged 18-65 who currently consume fewer than 2 portions of fruit and vegetables a day.
The main questions it aims to answer are:
Read more
- How does 5-a-day advice, with and without the inclusion of fruit juice, impact fruit and vegetable intake over a four-week period?
- What are the acceptability and perceived ease of increasing fruit and vegetable intake with and without the inclusion of fruit juice in 5-a-day recommendations?
- What are the effects of increasing fruit and vegetable intake with and without fruit juice on markers of metabolic health?
Researchers will answer these questions by comparing results from three groups of participants. All participants will provide a pre- and post-intervention blood sample, complete various questionnaires, and follow a four-week intervention that comprises educational material and a weekly £10 voucher. Over the course of the four weeks, they will report what they ate in a day on four different days.
The groups differ in the educational materials provided and where they can spend their voucher:
- Group 1 (Control) - information on the importance of including an experimental control in research and a weekly voucher to spend at a retailer of their choice,
- Group 2 (F\&V) - information on 5-a-day advice (excluding fruit juice) and a weekly voucher to spend in a supermarket on F\&V, and
- Group 3 (F\&V + Juice) - information on 5-a-day advice (including fruit juice) and a weekly voucher to spend in a supermarket on F\&V.
- Conditions
- Metabolic Health, Fruit and Vegetable Intake
- Being tested
- Educational information (Control), Educational information (Increasing F&V intake), Educational information (Increasing F&V intake + Juice)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational information (Control)Behavioural
Information packs will be developed for participants outlining the importance of a control group in research studies to maximise compliance. Participants will receive a £10 gift voucher weekly that they can spend at selected retailers of their choosing.
Educational information (Increasing F&V intake)Behavioural
Information packs will be developed to support participants in increasing their intake of whole fruits and vegetables, excluding fruit juice. The information packs will be developed using published guidance from the UK government, expert panels, and regulatory bodies. The packs will be co-developed with the public to ensure the guidance is appropriate for its target audience. Participants will also receive a £10 supermarket voucher weekly to purchase fruit and vegetables.
Educational information (Increasing F&V intake + Juice)Behavioural
Information packs will be developed to support participants in increasing their intake of whole fruits and vegetables, including fruit juice. The information packs will be developed using published guidance from the UK government, expert panels, and regulatory bodies. The packs will be co-developed with the public to ensure the guidance is appropriate for its target audience. Participants will also receive a £10 supermarket voucher weekly to purchase fruit and vegetables.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control) | Placebo comparator | Participants will be asked to maintain their habitual diet throughout the intervention. They will be provided with a brief document outlining the importance of a control group in research studies to maximise compliance. They will also receive £10/week vouchers during the intervention period and a further £60 on completion of the study to replicate voucher provision in the two intervention groups. Mimicking the voucher provision structure of the intervention groups will help to minimise participant drop out and will avoid any bias associated with differential financial remuneration between groups. Receives: Behavioral: Educational information (Control) |
| Group 2 (Whole F&V) | Active comparator | Participants will be provided with educational material to increase their fruit and vegetable intake to meet 5-a-day guidelines via exclusive intake of whole fruits/vegetables . They will receive £10/week supermarket vouchers during the intervention period to support fruit/vegetable purchase. They will receive a further £60 on completion of the study. Receives: Behavioral: Educational information (Increasing F&V intake) |
| Group 3 (Whole F&V + Juice) | Experimental | Participants will be provided with educational material to increase fruit and vegetable intake to meet 5-a-day guidelines, with recommendations to consume one portion per day via fruit juice/smoothies. Participants will receive the same financial support as group 2. Receives: Behavioral: Educational information (Increasing F&V intake + Juice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of daily fruit and vegetable portions (from dietary recalls)
The number of daily portions of fruit and vegetables consumed (including fruit juice in group 3) will be determined by 4 x 24-hour dietary recalls using the validated dietary recall software Intake24 (Foster et al., 2019).
Measured: 4 weeks
Secondary outcomes (17)
Number of daily fruit and vegetable portions (from brief screening tool)
The 6-item fruit and vegetable screener module from the BRFSS (Behavioral Risk Factor Surveillance System; CDC, 2020) will be used as a secondary measure to capture self-reported fruit and vegetable intake pre- and post-intervention. Data will be compared against the more granular dietary data from Intake24, to evaluate agreement and suitability of this tools for use as an outcome measure in future fruit and vegetable-based interventions.
Measured: 4 weeks
Concentration of plasma ascorbic acid
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of plasma ascorbic acid (μmol/L), or vitamin C, will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of serum carotenoids (lutein)
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of the serum carotenoid lutein (μmol/L) will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of serum carotenoids (zeaxanthin)
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of the serum carotenoid zeaxanthin (μmol/L) will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of serum carotenoids (beta-cryptoxanthin)
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of the serum carotenoid beta-cryptoxanthin (μmol/L) will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of serum carotenoids (lycopene)
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of the serum carotenoid lycopene (μmol/L) will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of serum carotenoids (alpha-carotene)
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of the serum carotenoid alpha-carotene (μmol/L) will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of serum carotenoids (beta-carotene)
Prior to and following the intervention, participants will provide a fasted blood sample for determining objective biomarkers of fruit and vegetable intake. Concentration of the serum carotenoid beta-carotene (μmol/L) will be measured via high-performance liquid chromatography (HPLC) using methods well-validated in our laboratory. These markers will help verify any participant-reported changes in fruit (including juice) and vegetable intake.
Measured: 4 weeks
Concentration of metabolic health markers
Prior to and following the intervention, participants will provide a fasted blood sample to determine markers of metabolic health. The Nightingale metabolomic biomarker panel, assessed pre- and post-intervention using Nuclear Magnetic Resonance (NMR) spectroscopy, will be used to evaluate the impact of the intervention on markers of metabolic health.
Measured: 4 weeks
Measure of depression symptom severity (PHQ-9)
The impact of the study interventions on symptoms of depression will be evaluated by administering the PHQ-9 questionnaire (a validated tool to measure levels of depression) pre- and post-intervention. Participants will provide information on the frequency with which they have been affected by depression-related symptoms (from not at all to nearly every day). There are four options for participants to select and each is associated with a score (not at all (0), several days (+1), more than half the days (+2), nearly every day (+3)). The sum of these scores indicates the level of depression severity (0-4 none/minimal; 5-9 mild anxiety; 10-14 moderate; 15 -19 moderately severe; 20-27 severe).
Measured: 4 weeks
Measure of anxiety symptom severity (GAD-7)
The impact of the study interventions on anxiety symptoms will be evaluated by administering the GAD-7 questionnaire (a validated tool to measure levels of anxiety) pre- and post-intervention. Participants will provide information on the frequency with which they have been affected by anxiety-related symptoms. There are four options for participants to select, and each option is associated with a score (not at all (0), several days (+1), more than half the days (+2), and nearly every day (+3)). The sum of these scores indicates the level of anxiety (0-4 minimal; 5-9 mild anxiety; 10-14 moderate anxiety; greater than 15 severe anxiety).
Measured: 4 weeks
Total number of gut symptoms (score)
Participants will complete the gut symptoms questionnaire (Winham and Hutchins, 2011) pre- and post-intervention. This involves responding to 4 close-ended questions (yes/no) enquiring about changes in the frequency of flatulence, stool frequency, stool consistency, or bloating frequency in the past week. The total number of symptoms the participant reported as having increased in the last week is their gut symptom score.
Measured: 4 weeks
Change in flatulence symptoms
Participants will complete the gut symptoms questionnaire (Winham and Hutchins, 2011) pre- and post-intervention. One of these items is a close-ended question (yes/no) enquiring about changes in the frequency of flatulence in the past week. If participants report a change, they will be asked to indicate the direction (increase/decrease) and magnitude of change (from 1 = least change to 5 = greatest change on a 5-point likert scale).
Measured: 4 weeks
Change in stool frequency
Participants will complete the gut symptoms questionnaire (Winham and Hutchins, 2011) pre- and post-intervention. One of these items is a close-ended question (yes/no) enquiring about changes in stool frequency in the past week. If participants report a change, they will be asked to indicate the direction (increase/decrease) and magnitude of change (from 1 = least change to 5 = greatest change on a 5-point likert scale).
Measured: 4 weeks
Change in stool consistency
Participants will complete the gut symptoms questionnaire (Winham and Hutchins, 2011) pre- and post-intervention. One of these items is a close-ended question (yes/no) enquiring about changes in stool consistency in the past week. If participants report a change, they will be asked to indicate the direction (increase/decrease) and magnitude of change (from 1 = least change to 5 = greatest change on a 5-point likert scale).
Measured: 4 weeks
Change in bloating frequency
Participants will complete the gut symptoms questionnaire (Winham and Hutchins, 2011) pre- and post-intervention. One of these items is a close-ended question (yes/no) enquiring about changes in bloating frequency in the past week. If participants report a change, they will be asked to indicate the direction (increase/decrease) and magnitude of change (from 1 = least change to 5 = greatest change on a 5-point likert scale).
Measured: 4 weeks
Assessment of intervention acceptability
Acceptability of the interventions will be assessed post-study via a custom questionnaire, using 5-point visual analogue scales and informed by the Theoretical Framework of Acceptability (Sekhon et al., 2017).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 Oct 2024
- Primary completion21 Mar 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Courtney Neal
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, European Fruit Juice Association (AIJN)
- Responsible party
- Sponsor-investigator, Courtney Neal, Newcastle University
- Investigators
- Oliver M Shannon, PhD, Principal investigator, Newcastle UniversityAnthony Watson, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628401
- Sponsor's protocol ID
- 2792/48171
- Other IDs
- NU-019324
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Neal C, Lietz G, Brandt K, Watson AW, Shannon OM. Including fruit juice and smoothies within 5-a-day fruit and vegetable intake recommendations: a randomised controlled trial investigating impact on levels of intake, mood and markers of health. Br J Nutr. 2026 May 22:1-15. doi: 10.1017/S0007114526107569. Online ahead of print.
PubMed 42169606
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Different Approaches to Increase Fruit and Vegetable Intake and Influence Markers of Metabolic Health in Humans
- ClinicalTrials.gov ID
- NCT06628401
- Acronym / sponsor ID
- 2792/48171
- Conditions
- Metabolic Health, Fruit and Vegetable Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Courtney NealUniversity, hospital or other
- Collaborators
- Newcastle University, European Fruit Juice Association (AIJN)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 8 Oct 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 experimental study aims to evaluate the effects of different strategies for increasing fruit and vegetable intake and to see how these interventions influence markers of health in people aged 18-65 who currently consume fewer than 2 portions of fruit and vegetables a day.
The main questions it aims to answer are:
- How does 5-a-day advice, with and without the inclusion of fruit juice, impact fruit and vegetable intake over a four-week period?
- What are the acceptability and perceived ease of increasing fruit and vegetable intake with and without the inclusion of fruit juice in 5-a-day recommendations?
- What are the effects of increasing fruit and vegetable intake with and without fruit juice on markers of metabolic health?
Researchers will answer these questions by comparing results from three groups of participants. All participants will provide a pre- and post-intervention blood sample, complete various questionnaires, and follow a four-week intervention that comprises educational material and a weekly £10 voucher. Over the course of the four weeks, they will report what they ate in a day on four different days.
The groups differ in the educational materials provided and where they can spend their voucher:
- Group 1 (Control) - information on the importance of including an experimental control in research and a weekly voucher to spend at a retailer of their choice,
- Group 2 (F\&V) - information on 5-a-day advice (excluding fruit juice) and a weekly voucher to spend in a supermarket on F\&V, and
- Group 3 (F\&V + Juice) - information on 5-a-day advice (including fruit juice) and a weekly voucher to spend in a supermarket on F\&V.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control) | Placebo comparator | Behavioral: Educational information (Control)Participants will be asked to maintain their habitual diet throughout the intervention. They will be provided with a brief document outlining the importance of a control group in research studies to maximise compliance. They will also receive £10/week vouchers during the intervention period and a further £60 on completion of the study to replicate voucher provision in the two intervention groups. Mimicking the voucher provision structure of the intervention groups will help to minimise participant drop out and will avoid any bias associated with differential financial remuneration between groups. |
| Group 2 (Whole F&V) | Active comparator | Behavioral: Educational information (Increasing F&V intake)Participants will be provided with educational material to increase their fruit and vegetable intake to meet 5-a-day guidelines via exclusive intake of whole fruits/vegetables . They will receive £10/week supermarket vouchers during the intervention period to support fruit/vegetable purchase. They will receive a further £60 on completion of the study. |
| Group 3 (Whole F&V + Juice) | Experimental | Behavioral: Educational information (Increasing F&V intake + Juice)Participants will be provided with educational material to increase fruit and vegetable intake to meet 5-a-day guidelines, with recommendations to consume one portion per day via fruit juice/smoothies. Participants will receive the same financial support as group 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 - 65 years
- Currently consuming ≤2 portions of fruit and vegetables per day
Key exclusion criteria (4 listed)
- Using high-dose vitamins, minerals or dietary supplements that could interfere with biomarker assessment of fruit and vegetable consumption
- Have a food sensitivity, allergy or other dietary restriction (e.g., following a weight loss diet) that would limit the ability to take part in the study
- Have a medical condition (e.g., diabetes or gastrointestinal disorders) that would limit the ability to take part in the study
- Currently pregnant or lactating
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 |
|---|---|---|
| Educational information (Control)Information packs will be developed for participants outlining the importance of a control group in research studies to maximise compliance. Participants will receive a £10 gift voucher weekly that they can spend at selected retailers of their choosing. | Behavioural | Group 1 (Control) |
| Educational information (Increasing F&V intake)Information packs will be developed to support participants in increasing their intake of whole fruits and vegetables, excluding fruit juice. The information packs will be developed using published guidance from the UK government, expert panels, and regulatory bodies. The packs will be co-developed with the public to ensure the guidance is appropriate for its target audience. Participants will also receive a £10 supermarket voucher weekly to purchase fruit and vegetables. | Behavioural | Group 2 (Whole F&V) |
| Educational information (Increasing F&V intake + Juice)Information packs will be developed to support participants in increasing their intake of whole fruits and vegetables, including fruit juice. The information packs will be developed using published guidance from the UK government, expert panels, and regulatory bodies. The packs will be co-developed with the public to ensure the guidance is appropriate for its target audience. Participants will also receive a £10 supermarket voucher weekly to purchase fruit and vegetables. | Behavioural | Group 3 (Whole F&V + Juice) |
Primary outcome
Number of daily fruit and vegetable portions (from dietary recalls)
Time frame: 4 weeks
The number of daily portions of fruit and vegetables consumed (including fruit juice in group 3) will be determined by 4 x 24-hour dietary recalls using the validated dietary recall software Intake24 (Foster et al., 2019).
17 secondary outcomes
Number of daily fruit and vegetable portions (from brief screening tool)
Time frame: 4 weeks
Concentration of plasma ascorbic acid
Time frame: 4 weeks
Concentration of serum carotenoids (lutein)
Time frame: 4 weeks
Concentration of serum carotenoids (zeaxanthin)
Time frame: 4 weeks
Concentration of serum carotenoids (beta-cryptoxanthin)
Time frame: 4 weeks
Concentration of serum carotenoids (lycopene)
Time frame: 4 weeks
Concentration of serum carotenoids (alpha-carotene)
Time frame: 4 weeks
Concentration of serum carotenoids (beta-carotene)
Time frame: 4 weeks
Concentration of metabolic health markers
Time frame: 4 weeks
Measure of depression symptom severity (PHQ-9)
Time frame: 4 weeks
Measure of anxiety symptom severity (GAD-7)
Time frame: 4 weeks
Total number of gut symptoms (score)
Time frame: 4 weeks
Change in flatulence symptoms
Time frame: 4 weeks
Change in stool frequency
Time frame: 4 weeks
Change in stool consistency
Time frame: 4 weeks
Change in bloating frequency
Time frame: 4 weeks
Assessment of intervention acceptability
Time frame: 4 weeks
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 6 Oct 2025.
- Derived from this study: PubMed 42169606Neal C, Lietz G, Brandt K, Watson AW, Shannon OM. Including fruit juice and smoothies within 5-a-day fruit and vegetable intake recommendations: a randomised controlled trial investigating impact on levels of intake, mood and markers of health. Br J Nutr. 2026 May 22:1-15. doi: 10.1017/S0007114526107569. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Oliver M Shannon, PhD principal investigator
Newcastle University
Anthony Watson, PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational information (Increasing F&V intake) and Educational information (Increasing F&V intake + Juice) in people with Metabolic Health and Fruit and Vegetable Intake, run by Courtney Neal at 1 site in United Kingdom.
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 2 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 6 Oct 2025. 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 United Kingdom. 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?
Number of daily fruit and vegetable portions (from dietary recalls) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628401, which also lists 1 linked publication.
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 6 Oct 2025.