Health TrialsbyHealthPanel

Bite Sized Biomarkers

ConditionsDietary AssessmentDiet, Food, and NutritionCarotenoid Status
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

planned relocation within the study window

currently pregnant or plans to become pregnant within the study window

unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Bite-sized Biomarkers: Knowledge of skin carotenoid scoresExperimental treatment 1 intervention
Group B: Bite-sized Biomarkers: Masked to Skin Carotenoid ScoresActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Skin carotenoid scores

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

Time frame
Baseline, 12-weeks, and 6-months.

Secondary outcomes

1

Dietary Intake

Dietary intake will be calculated using the Healthy Eating Index (HEI)-2020

Time frame
Baseline, 6-months
2

Depression

Symptoms of depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9)

Time frame
Baseline, 6-months
3

Anxiety

Symptoms of anxiety will be measured using the 7-item Generalized Anxiety Disorder (GAD-7).

Time frame
Baseline, 6-month
4

Food security status

Food security status will be measured using the USDA Adult Food Security Survey Module

Time frame
Baseline, 6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: