Dietary AssessmentNCT07845383
Bite Sized Biomarkers
A study testing Bite-sized Biomarkers: Skin carotenoid scores in people with Dietary Assessment and Diet, Food, and Nutrition, run by Stanford University at 1 site in United States.
Trial summary
The primary objective of this study is to rigorously evaluate the effectiveness of a Food is Medicine (FIM) intervention using objective biomarkers and to determine the role of nutritional monitoring on the impact and sustainability of integrating nutrition supports into primary care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Assessment, Diet, Food, and Nutrition, Carotenoid Status
- What is being tested?
- Bite-sized Biomarkers: Skin carotenoid scores
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 28 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults (18 years or older)
- at risk for food insecurity (affirmative response to one or more questions on the Huger Vital Signs
- at risk or experiencing a nutrition-sensitive chronic conditions (e.g., obesity, type 2 diabetes, MASLD, hypertension, etc.)
- able to read and write in English or Spanish
Who cannot join
- planned relocation within the study window
- currently pregnant or plans to become pregnant within the study window
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94114
Marcela Radtke, PhD, 650-260-4767, mdradtke@stanford.edu
About this study
Official title: Bite Sized Biomarkers: Promoting Health Behavior Change Through Objective Dietary Monitoring
The primary objective of this study is to rigorously evaluate the effectiveness of a Food is Medicine (FIM) intervention using objective biomarkers and to determine the role of nutritional monitoring on the impact and sustainability of integrating nutrition supports into primary care.
Read the detailed description
A critical research gap of FIM is objective, non-invasive measures of dietary intake for rigorously evaluating interventions, such as produce prescription programs. The Veggie Meter® is a research-grade tool strongly correlated with plasma carotenoid levels that utilizes pressure-mediated reflection spectroscopy to rapidly detect carotenoids in the skin, correcting for melanin concentration across skin tones, to estimate V/F intake over 30 days. Carotenoids are fat-soluble compounds found ubiquitously in V/F, detectable in the diet, plasma, and body tissues and may contain bioactive properties that have been demonstrated to slow the progression of chronic disease development. Carotenoid status may serve as a comprehensive, objective, and non-invasive measures of dietary intake that has yet to be implemented in the evaluation of FIM. In addition to being ideally suited for evaluating the effectiveness of FIM, the Veggie Meter® may serve as a promising tool to incorporate into primary care for better assessing dietary intake for prevention and treatment of diet-related chronic diseases. With dietary intake and behavioral lifestyle modifications at the core of chronic disease management, understanding the role of nutritional monitoring in primary care on initiating and sustaining patient health-related behavior change is essential to reduce disease prevalence and severity.
The specific aims of the project are:
Aim 1: Evaluate whether participants in a FIM intervention have higher skin carotenoid scores compared to those not in a FIM intervention over 6 months.
Aim 2: Determine whether informing participants of their skin carotenoid scores at baseline is effective for increasing diet quality at 6 months compared to not receiving skin carotenoid scores. Participants and controls (n=150) will be randomized to receive skin carotenoid scores and their clinical lab values (HbA1c, lipids, BP, anthropometrics) or to only receive their clinical lab values.
Aim 3: Examine barriers and facilitators of integrating objective, non-invasive nutritional monitoring into primary care using a convergent mixed methods design.
- Being tested
- Bite-sized Biomarkers: Skin carotenoid scores
- Keywords
- Skin carotenoids, Food is Medicine, Nutritional monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bite-sized Biomarkers: Skin carotenoid scoresBehavioural
In this intervention, participants will be randomized to either receive or be masked to additional information on their nutritional status by measuring skin carotenoid scores as a proxy of fruit and vegetable intake to see if knowledge of status at baseline leads to more dietary behavior change.
| Study group | Role | What they receive |
|---|---|---|
| Bite-sized Biomarkers: Knowledge of skin carotenoid scores | Experimental | Participants will be randomized to receive their skin carotenoid scores at baseline. Receives: Behavioral: Bite-sized Biomarkers: Skin carotenoid scores |
| Bite-sized Biomarkers: Masked to Skin Carotenoid Scores | Active comparator | Participants will be randomized to be masked to their skin carotenoid values until the follow-up visit. Receives: Behavioral: Bite-sized Biomarkers: Skin carotenoid scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin carotenoid scores
Change in skin carotenoid scores measured using pressure-mediated reflection spectroscopy (Veggie Meter)
Measured: Baseline, 12-weeks, and 6-months.
Secondary outcomes (5)
Dietary Intake
Dietary intake will be calculated using the Healthy Eating Index (HEI)-2020
Measured: Baseline, 6-months
Depression
Symptoms of depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9)
Measured: Baseline, 6-months
Anxiety
Symptoms of anxiety will be measured using the 7-item Generalized Anxiety Disorder (GAD-7).
Measured: Baseline, 6-month
Food security status
Food security status will be measured using the USDA Adult Food Security Survey Module
Measured: Baseline, 6-months
Nutrition security status
The Center for Nutrition and Health Impact 4-item nutrition security screener will be used.
Measured: Baseline, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion28 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Radtke, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845383
- Sponsor's protocol ID
- 88545
- Other IDs
- 1K99DK147690-01
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant anonymity, individual participant data is not expected to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bite Sized Biomarkers: Promoting Health Behavior Change Through Objective Dietary Monitoring
- ClinicalTrials.gov ID
- NCT07845383
- Acronym / sponsor ID
- 88545
- Keywords
- Skin carotenoids, Food is Medicine, Nutritional monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 28 Sep 2026 (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.
The primary objective of this study is to rigorously evaluate the effectiveness of a Food is Medicine (FIM) intervention using objective biomarkers and to determine the role of nutritional monitoring on the impact and sustainability of integrating nutrition supports into primary care.
Detailed description
A critical research gap of FIM is objective, non-invasive measures of dietary intake for rigorously evaluating interventions, such as produce prescription programs. The Veggie Meter® is a research-grade tool strongly correlated with plasma carotenoid levels that utilizes pressure-mediated reflection spectroscopy to rapidly detect carotenoids in the skin, correcting for melanin concentration across skin tones, to estimate V/F intake over 30 days. Carotenoids are fat-soluble compounds found ubiquitously in V/F, detectable in the diet, plasma, and body tissues and may contain bioactive properties that have been demonstrated to slow the progression of chronic disease development. Carotenoid status may serve as a comprehensive, objective, and non-invasive measures of dietary intake that has yet to be implemented in the evaluation of FIM. In addition to being ideally suited for evaluating the effectiveness of FIM, the Veggie Meter® may serve as a promising tool to incorporate into primary care for better assessing dietary intake for prevention and treatment of diet-related chronic diseases. With dietary intake and behavioral lifestyle modifications at the core of chronic disease management, understanding the role of nutritional monitoring in primary care on initiating and sustaining patient health-related behavior change is essential to reduce disease prevalence and severity.
The specific aims of the project are:
Aim 1: Evaluate whether participants in a FIM intervention have higher skin carotenoid scores compared to those not in a FIM intervention over 6 months.
Aim 2: Determine whether informing participants of their skin carotenoid scores at baseline is effective for increasing diet quality at 6 months compared to not receiving skin carotenoid scores. Participants and controls (n=150) will be randomized to receive skin carotenoid scores and their clinical lab values (HbA1c, lipids, BP, anthropometrics) or to only receive their clinical lab values.
Aim 3: Examine barriers and facilitators of integrating objective, non-invasive nutritional monitoring into primary care using a convergent mixed methods design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bite-sized Biomarkers: Knowledge of skin carotenoid scores | Experimental | Behavioral: Bite-sized Biomarkers: Skin carotenoid scoresParticipants will be randomized to receive their skin carotenoid scores at baseline. |
| Bite-sized Biomarkers: Masked to Skin Carotenoid Scores | Active comparator | Behavioral: Bite-sized Biomarkers: Skin carotenoid scoresParticipants will be randomized to be masked to their skin carotenoid values until the follow-up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults (18 years or older)
- at risk for food insecurity (affirmative response to one or more questions on the Huger Vital Signs
- at risk or experiencing a nutrition-sensitive chronic conditions (e.g., obesity, type 2 diabetes, MASLD, hypertension, etc.)
- able to read and write in English or Spanish
Key exclusion criteria (3 listed)
- planned relocation within the study window
- currently pregnant or plans to become pregnant within the study window
- unable to provide informed consent
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 |
|---|---|---|
| Bite-sized Biomarkers: Skin carotenoid scoresIn this intervention, participants will be randomized to either receive or be masked to additional information on their nutritional status by measuring skin carotenoid scores as a proxy of fruit and vegetable intake to see if knowledge of status at baseline leads to more dietary behavior change. | Behavioural | Bite-sized Biomarkers: Knowledge of skin carotenoid scores, Bite-sized Biomarkers: Masked to Skin Carotenoid Scores |
Primary outcome
Skin carotenoid scores
Time frame: Baseline, 12-weeks, and 6-months.
Change in skin carotenoid scores measured using pressure-mediated reflection spectroscopy (Veggie Meter)
5 secondary outcomes
Dietary Intake
Time frame: Baseline, 6-months
Depression
Time frame: Baseline, 6-months
Anxiety
Time frame: Baseline, 6-month
Food security status
Time frame: Baseline, 6-months
Nutrition security status
Time frame: Baseline, 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. To protect participant anonymity, individual participant data is not expected to be shared with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bite-sized Biomarkers: Skin carotenoid scores in people with Dietary Assessment and Diet, Food, and Nutrition, run by Stanford University at 1 site in United States.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Sep 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcela Radtke, PhD (650-260-4767, mdradtke@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin carotenoid scores (time frame: Baseline, 12-weeks, and 6-months.). 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 28 Sep 2026.