An interventional study of Bite-sized Biomarkers: Skin carotenoid scores in Dietary Assessment, Diet, Food, and Nutrition and Carotenoid Status, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Participants will be randomized to receive their skin carotenoid scores at baseline.
Behavioral: Bite-sized Biomarkers: Skin carotenoid scores
Participants will be randomized to be masked to their skin carotenoid values until the follow-up visit.
Behavioral: Bite-sized Biomarkers: Skin carotenoid scores
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.
Skin carotenoid scores
Change in skin carotenoid scores measured using pressure-mediated reflection spectroscopy (Veggie Meter)
Time frame: Baseline, 12-weeks, and 6-months.
Dietary Intake
Dietary intake will be calculated using the Healthy Eating Index (HEI)-2020
Time frame: Baseline, 6-months
Depression
Symptoms of depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 6-months
Anxiety
Symptoms of anxiety will be measured using the 7-item Generalized Anxiety Disorder (GAD-7).
Time frame: Baseline, 6-month
Food security status
Food security status will be measured using the USDA Adult Food Security Survey Module
Time frame: Baseline, 6-months
Nutrition security status
The Center for Nutrition and Health Impact 4-item nutrition security screener will be used.
Time frame: Baseline, 6-months
Plan to share: No — To protect participant anonymity, individual participant data is not expected to be shared with other researchers.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Stanford University