Bite Sized Biomarkers

NCT07845383 | Not Yet Recruiting DMC

• 2 other identifiers: 885451K99DK147690-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dietary Assessment; Diet, Food, and Nutrition; Carotenoid Status

Keywords

Skin carotenoids; Food is Medicine; Nutritional monitoring

Outcome Measures

Primary Outcomes (1)

• Skin carotenoid scores

  Change in skin carotenoid scores measured using pressure-mediated reflection spectroscopy (Veggie Meter)

  Baseline, 12-weeks, and 6-months.

Secondary Outcomes (5)

• Dietary Intake

  Baseline, 6-months

• Depression

  Baseline, 6-months

• Anxiety

  Baseline, 6-month

• Food security status

  Baseline, 6-months

• Nutrition security status

  Baseline, 6-months

Study Arms (2)

Bite-sized Biomarkers: Knowledge of skin carotenoid scores

EXPERIMENTAL

Participants will be randomized to receive their skin carotenoid scores at baseline.

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.

Behavioral: Bite-sized Biomarkers: Skin carotenoid scores

Interventions

Bite-sized Biomarkers: Skin carotenoid scores BEHAVIORAL

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.

Bite-sized Biomarkers: Knowledge of skin carotenoid scores; Bite-sized Biomarkers: Masked to Skin Carotenoid Scores

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• planned relocation within the study window
• currently pregnant or plans to become pregnant within the study window
• unable to provide informed consent

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94114, United States

Location

Central Study Contacts

Marcela Radtke, PhD

CONTACT

650-260-4767; mdradtke@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 28, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)