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Recruiting NCT07478068

NCT07478068 Can Personalised Digital Feedback Help Increase Plant Food Intake?

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Clinical Trial Summary
NCT ID NCT07478068
Status Recruiting
Phase
Sponsor University of Bath
Condition Plant Food Intake
Study Type INTERVENTIONAL
Enrollment 315 participants
Start Date 2025-05-14
Primary Completion 2026-03-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 45 Years
Study Type INTERVENTIONAL
Interventions
Personalised FeedbackControl

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 315 participants in total. It began in 2025-05-14 with a primary completion date of 2026-03-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Inadequate plant food intake is a leading modifiable risk factor for non-communicable disease. However, on average, 88% of individuals do not consume adequate amounts of vegetables. Using digital technology may help improve health behaviours , with this potentially providing an accessible route to increasing plant food intake. However, uptake and engagement with applications designed to influence health behaviours is generally poor , and few studies have examined the main factors supporting user engagement and retention. Personalised dietary feedback, such as the provision of personalised advice or recipes, has the potential to enhance this process. However, whether nutritional interventions utilising personalised dietary feedback support user interaction, engagement, and retention remains to be studied. Hence, the proposed project is a proof-of-concept study aiming to assess the effectiveness of using an application with personalised dietary feedback to support increased healthy plant food intake. 315 healthy males and females, between the ages of 18- and 45-years who self-report less than 50% of the recommended intake of vegetable consumption will participate in the study. Before the intervention, participants will receive web-based instruction on the use of the smartphone application. Subsequently, participants will log all meals for two-weeks using the application to generate a baseline plant food consumption profile. In the baseline period, participants will wear a continuous glucose monitor. This will inform their individualised goals and possible feedback for the intervention period. The intervention will be 4-weeks in duration, consisting of the use of a personalised dietary program application, which will provide both recipes and feedback. Those randomised to the control will only have access to the meal logging feature. Throughout this period, participants will wear a smartwatch to track sleep metrics such as sleep onset and duration. Following the four-week intervention period, participants will be able to continue using the app for a six-week period, during which engagement with the application over time will be ascertained via telemetry. At the end of the follow-up, participants will receive an exit questionnaire to provide insight on their experience with the application, attitudes, habits and knowledge regarding consumption of plant foods, and self-perceived impact on health and dietary habits. To provide mechanistic insight, a subset of participants (n = 50) will visit the laboratory at the University of Bath on two occasions (approximately 45 minutes each) - baseline and post-intervention. During laboratory visits, participants will provide blood pressure and body weight measurements, as well as saliva and venous blood samples. Saliva samples will be assessed for salivary cortisol, and blood samples will be assessed for the following: plasma glucose \& insulin; plasma uric acid; plasma ascorbic acid; plasma tocopherols; serum carotenoids; plasma cytokines; plasma CRP and ferritin; F2-Isoprostanes; immune cell inflammatory capacity; HbA1c.

Eligibility Criteria

Inclusion Criteria: * Healthy males and females, age at start of the study ≥ 18 and ≤ 45 years; * Non-rejectors of Knorr (due to the recipes in the PDP application); * Currently cooking or intending to cook (\*themselves or partner) at least one main meal at home for at least five days a week; * Indicated desire to eat more vegetables; * In possession of an Android or iOS-based smartphone; * Willing to use an app to receive information and log all meals daily; * Currently using or willing to use a smartwatch; * Able to provide informed consent. Exclusion Criteria: * High reported baseline veg intake (participants need to self-report less than 50% of the UK rec / self-reported intake above the UK adult average (206 g/2.6 servings)); * Reported participation in another nutritional or biomedical trial within 1 month before the screening or during the study; * Planned frequent travel (\>2/month) and travel to countries with time zone \>GMT +04:00 during the study period; * Habitual consumption of \>14 units (female participants) and \>21 units (male participants) alcoholic drinks in a typical week; * Reported start or change in use of any nicotine containing products directly preceding the study or during the study itself; * If female, is pregnant (or has been pregnant during the last \<3 months) or will be planning pregnancy during the study period; * If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period; * Reported dietary habits: medically prescribed diet, slimming diet, any condition or self-prescribed diet that restricts consumption of vegetables, not used to eating at least 3 meals a day; * Reported body mass loss/gain (\>5%) in the last 3 months before the study. Self-reported history of major depressive disorders and/or current use antidepressive/antianxiety medication; * Clinically diagnosed sleep disorders and/or use prescribed sleep medication. Taking medication (including traditional medicines and or dietary supplements) which may pose undue personal risk or introduce bias into study measurements, as judged by the PI; * An allergy to adhesives, which would prevent proper attachment of the CGM; * Being an employee of any company developing personalised diet applications, including Salus Optima or Unilever.

Frequently Asked Questions

Who can join the NCT07478068 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Plant Food Intake. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07478068 currently recruiting?

Yes, NCT07478068 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Bath to inquire about joining.

Where is the NCT07478068 trial being conducted?

This trial is being conducted at Bath, United Kingdom.

Who is sponsoring the NCT07478068 clinical trial?

NCT07478068 is sponsored by University of Bath. The trial plans to enroll 315 participants.

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