Dietary HabitsNCT04056624
Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy
A study testing High carotenoid juice in people with Dietary Habits and Diet, Healthy, run by East Carolina University at 3 sites in United States.
Trial summary
The central goal of this proposal is to examine validity and sensitivity of RS-assessed skin carotenoid status as a marker of F\&V intake in a racially and ethnically diverse sample of individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Diet, Healthy
- What is being tested?
- High carotenoid juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2021to 14 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified as one of the racial/ethnic groups of focus
- Read/speak English
- Between 18 and 65 years of age
- BMI 18.5-34.9 kg/m2
- Non-pregnant
- Non-lactating
Show all 9Show fewer
- Healthy (no chronic disease)
- Not taking lipid-altering medication (medicines that lower cholesterol or triglycerides)
- Weight stable (have not gained or lost more than 15 pounds in the last 3 months).
Who cannot join
- Not of one of the four racial/ethnic groups of focus
- Not able to read/speak English
- Under 18 years of age or over 65 years of age, do not
- BMI less than 18.5 or more than 34.9 kg/m2
- Pregnant (or have been pregnant in the last 6 weeks)
- Lactating
Show all 10Show fewer
- High blood sugar ( ≥126 mg/dl)
- Chronic disease such as cardiovascular disease, diabetes, chronic kidney disease, diabetes cancer other than non-melanoma skin cancer (within the last 5 years), or other weight-related chronic diseases.
- Taking medication that lowers cholesterol or triglycerides Diagnosed with/ treated for Crohn's disease.
- Not weight stable (gained or lost more than 15 pounds in the last three months)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
East Carolina University
Greenville, North Carolina, 27834
Baylor College of Medicine
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy as a Measure of Fruit and Vegetable Consumption in a Diverse Community
The central goal of this proposal is to examine validity and sensitivity of RS-assessed skin carotenoid status as a marker of F\&V intake in a racially and ethnically diverse sample of individuals. First, investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino (n=213). Then the investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. The investigators will conduct a 6-week randomized controlled trial of a carotenoid-containing juice intervention [placebo control, low and high dose juice (N=156). Finally, the genetic basis for racial/ethnic group differences in skin carotenoid responses to diet will be investigated through hypothesis-driven genomic analysis of participants from Aims 1 and 2.
Read the detailed description
A diet rich in fruits and vegetables (F\&Vs) is associated with lower risk of nutrition-related chronic diseases and all-cause mortality. Despite these benefits, the US population under-consumes F\&Vs, with particularly low intake in disadvantaged populations. Low F\&V intake results in higher rates of nutrition-related chronic disease among disadvantaged populations when compared with more advantaged populations. Detecting and addressing inadequate F\&V intake in these populations is needed to reduce such disparities. Yet, there is still no commonly used predictive, objective measure of F\&V intake for surveillance or determination of policy or intervention effectiveness. The current objective, "gold standard" marker of F\&V intake is blood carotenoid concentration-an expensive, time-intensive, and invasive measurement. Traditional methods of self-reported dietary assessment are imprecise and have diminished utility in rural and disadvantaged populations due to low literacy, numeracy, and internet connectivity. In the past decade, skin carotenoid status assessed by non-invasive resonance Raman spectroscopy (RRS) has emerged as a promising biomarker of F\&V intake. Reflection spectroscopy (RS) is an improvement over RRS, offering stronger signals, faster data acquisition, and greater portability in a commercially available device (Veggie Meter, Longevity Link Corporation). However, a hurdle impedes use of RS in scientific studies: to date, nearly all of the non-invasive skin carotenoid validation has been conducted in non-Hispanic whites, primarily by RRS. Therefore, it is critical to evaluate RS in racially and ethnically diverse populations. The central goal of this proposal is to examine validity and sensitivity of RS-assessed skin carotenoid status as a marker of F\&V intake in a racially and ethnically diverse sample of individuals. First, the investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino (target n = 320 but due to Covid-19, N=213). Then the investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. The investigators will conduct an 6-week randomized controlled trial of a carotenoid-containing juice intervention [placebo control, low and high dose juice across 4 genetically-stratified racial-ethnic groups (goal n = 156). Finally, the genetic basis for racial/ethnic group differences in skin carotenoid responses to diet will be investigated through hypothesis-driven genomic analysis of participants from Aims 1 and 2. The results of this study will prepare RS for mass deployment in population surveillance studies and community-based intervention trials, ultimately leading to more accurate determination of the most effective strategies to reduce health disparities related to low F\&V intake in the United States and beyond.
- Conditions
- Dietary Habits, Diet, Healthy
- Being tested
- High carotenoid juice, Placebo control - Apple juice
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High carotenoid juiceDietary supplement
Juice with high carotenoids
Placebo control - Apple juiceDietary supplement
Juice with negligible carotenoids
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 1 x 6 ounces of carotenoid-containing juice (6 mg carotenoids/6 oz) Receives: Dietary Supplement: High carotenoid juice |
| High dose | Experimental | 2 x 6 ounces of carotenoid-containing juice (12 mg carotenoids/12 oz) Receives: Dietary Supplement: High carotenoid juice |
| Placebo | Placebo comparator | 12 ounces of apple juice (negligible carotenoids 0.06 mg/12 oz) Receives: Dietary Supplement: Placebo control - Apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-week Change in Skin Carotenoid Status
Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the skin carotenoid value at 3 weeks minus the value at baseline.
Measured: Change in skin carotenoid status from baseline to 3 weeks
6-week Change in Skin Carotenoid Status
Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the value at 6 weeks minus the value at baseline.
Measured: Change in skin carotenoid status from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start28 Jun 2021
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- 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
- Model description
- First, investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino. Then investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. Investigators will conduct a 6-week randomized controlled trial of a carotenoid-containing juice intervention \[placebo control, low and high dose juice across 4 genetically-stratified racial-ethnic groups (n = 156).
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Baylor College of Medicine
- Responsible party
- Principal investigator, Stephanie Pitts, East Carolina University
- Investigators
- Stephanie B Jilcott Pitts, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056624
- Sponsor's protocol ID
- 1R01HL142544-01A1
- Status last verified
- May 2023
- First submitted
- 9 Aug 2019
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other researchers.
Publications
Jilcott Pitts SB, Wu Q, Laska MN, Moran NE. Two Spectroscopy Devices Can Approximate Fruit and Vegetable Intake in a Racially and Ethnically Diverse Sample. Curr Dev Nutr. 2025 Jun 4;9(7):107482. doi: 10.1016/j.cdnut.2025.107482. eCollection 2025 Jul.
PubMed 40654376Jilcott Pitts SB, Wu Q, Moran NE, Laska MN, Harnack L. Examining Potential Modifiers of Human Skin and Plasma Carotenoid Responses in a Randomized Trial of a Carotenoid-Containing Juice Intervention. J Nutr. 2023 Nov;153(11):3287-3294. doi: 10.1016/j.tjnut.2023.09.014. Epub 2023 Sep 23.
PubMed 37742797Jilcott Pitts S, Moran NE, Laska MN, Wu Q, Harnack L, Moe S, Carr-Manthe P, Gates E, Chang J, Zaidi Y, Gelineau A, Berg L, Craft NE. Reflection Spectroscopy-Assessed Skin Carotenoids Are Sensitive to Change in Carotenoid Intake in a 6-Week Randomized Controlled Feeding Trial in a Racially/Ethnically Diverse Sample. J Nutr. 2023 Apr;153(4):1133-1142. doi: 10.1016/j.tjnut.2023.02.017. Epub 2023 Feb 18.
PubMed 36804322
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy as a Measure of Fruit and Vegetable Consumption in a Diverse Community
- ClinicalTrials.gov ID
- NCT04056624
- Acronym / sponsor ID
- 1R01HL142544-01A1
- Conditions
- Dietary Habits, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- University of Minnesota, Baylor College of Medicine
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central goal of this proposal is to examine validity and sensitivity of RS-assessed skin carotenoid status as a marker of F\&V intake in a racially and ethnically diverse sample of individuals. First, investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino (n=213). Then the investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. The investigators will conduct a 6-week randomized controlled trial of a carotenoid-containing juice intervention [placebo control, low and high dose juice (N=156). Finally, the genetic basis for racial/ethnic group differences in skin carotenoid responses to diet will be investigated through hypothesis-driven genomic analysis of participants from Aims 1 and 2.
Detailed description
A diet rich in fruits and vegetables (F\&Vs) is associated with lower risk of nutrition-related chronic diseases and all-cause mortality. Despite these benefits, the US population under-consumes F\&Vs, with particularly low intake in disadvantaged populations. Low F\&V intake results in higher rates of nutrition-related chronic disease among disadvantaged populations when compared with more advantaged populations. Detecting and addressing inadequate F\&V intake in these populations is needed to reduce such disparities. Yet, there is still no commonly used predictive, objective measure of F\&V intake for surveillance or determination of policy or intervention effectiveness. The current objective, "gold standard" marker of F\&V intake is blood carotenoid concentration-an expensive, time-intensive, and invasive measurement. Traditional methods of self-reported dietary assessment are imprecise and have diminished utility in rural and disadvantaged populations due to low literacy, numeracy, and internet connectivity. In the past decade, skin carotenoid status assessed by non-invasive resonance Raman spectroscopy (RRS) has emerged as a promising biomarker of F\&V intake. Reflection spectroscopy (RS) is an improvement over RRS, offering stronger signals, faster data acquisition, and greater portability in a commercially available device (Veggie Meter, Longevity Link Corporation). However, a hurdle impedes use of RS in scientific studies: to date, nearly all of the non-invasive skin carotenoid validation has been conducted in non-Hispanic whites, primarily by RRS. Therefore, it is critical to evaluate RS in racially and ethnically diverse populations. The central goal of this proposal is to examine validity and sensitivity of RS-assessed skin carotenoid status as a marker of F\&V intake in a racially and ethnically diverse sample of individuals. First, the investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino (target n = 320 but due to Covid-19, N=213). Then the investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. The investigators will conduct an 6-week randomized controlled trial of a carotenoid-containing juice intervention [placebo control, low and high dose juice across 4 genetically-stratified racial-ethnic groups (goal n = 156). Finally, the genetic basis for racial/ethnic group differences in skin carotenoid responses to diet will be investigated through hypothesis-driven genomic analysis of participants from Aims 1 and 2. The results of this study will prepare RS for mass deployment in population surveillance studies and community-based intervention trials, ultimately leading to more accurate determination of the most effective strategies to reduce health disparities related to low F\&V intake in the United States and beyond.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- First, investigators will examine the association (RS Device Validity) between RS-assessed skin carotenoids and the primary outcomes of objectively-measured plasma carotenoids and self-reported F\&V consumption across four diverse groups: African-American/Black, Asian, White, and Hispanic/Latino. Then investigators will conduct a randomized controlled trial to define the relative skin carotenoid responses (RS Device Sensitivity) across racial-ethnic groups, in comparison with plasma carotenoid responses. Investigators will conduct a 6-week randomized controlled trial of a carotenoid-containing juice intervention [placebo control, low and high dose juice across 4 genetically-stratified racial-ethnic groups (n = 156).
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Dietary Supplement: High carotenoid juice1 x 6 ounces of carotenoid-containing juice (6 mg carotenoids/6 oz) |
| High dose | Experimental | Dietary Supplement: High carotenoid juice2 x 6 ounces of carotenoid-containing juice (12 mg carotenoids/12 oz) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo control - Apple juice12 ounces of apple juice (negligible carotenoids 0.06 mg/12 oz) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Self-identified as one of the racial/ethnic groups of focus
- Read/speak English
- Between 18 and 65 years of age
- BMI 18.5-34.9 kg/m2
- Non-pregnant
Key exclusion criteria (10 listed)
- Not of one of the four racial/ethnic groups of focus
- Not able to read/speak English
- Under 18 years of age or over 65 years of age, do not
- BMI less than 18.5 or more than 34.9 kg/m2
- Pregnant (or have been pregnant in the last 6 weeks)
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 |
|---|---|---|
| High carotenoid juiceJuice with high carotenoids | Dietary supplement | High dose, Low dose |
| Placebo control - Apple juiceJuice with negligible carotenoids | Dietary supplement | Placebo |
Primary outcome
3-week Change in Skin Carotenoid Status
Time frame: Change in skin carotenoid status from baseline to 3 weeks
Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the skin carotenoid value at 3 weeks minus the value at baseline.
6-week Change in Skin Carotenoid Status
Time frame: Change in skin carotenoid status from baseline to 6 weeks
Skin carotenoid level is a number from 0 to 800 that approximates carotenoids in the skin. The Veggie Meter device uses pressure mediated reflection spectroscopy to assess skin carotenoid level in the fingertip. Skin carotenoid levels are positively correlated with fruit and vegetable intake. A higher score generally indicates more fruit and vegetable intake, which is thought to be a better outcome. The primary outcome was change in skin carotenoid levels calculated by the value at 6 weeks minus the value at baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40654376Jilcott Pitts SB, Wu Q, Laska MN, Moran NE. Two Spectroscopy Devices Can Approximate Fruit and Vegetable Intake in a Racially and Ethnically Diverse Sample. Curr Dev Nutr. 2025 Jun 4;9(7):107482. doi: 10.1016/j.cdnut.2025.107482. eCollection 2025 Jul.
- Derived from this study: PubMed 37742797Jilcott Pitts SB, Wu Q, Moran NE, Laska MN, Harnack L. Examining Potential Modifiers of Human Skin and Plasma Carotenoid Responses in a Randomized Trial of a Carotenoid-Containing Juice Intervention. J Nutr. 2023 Nov;153(11):3287-3294. doi: 10.1016/j.tjnut.2023.09.014. Epub 2023 Sep 23.
- Derived from this study: PubMed 36804322Jilcott Pitts S, Moran NE, Laska MN, Wu Q, Harnack L, Moe S, Carr-Manthe P, Gates E, Chang J, Zaidi Y, Gelineau A, Berg L, Craft NE. Reflection Spectroscopy-Assessed Skin Carotenoids Are Sensitive to Change in Carotenoid Intake in a 6-Week Randomized Controlled Feeding Trial in a Racially/Ethnically Diverse Sample. J Nutr. 2023 Apr;153(4):1133-1142. doi: 10.1016/j.tjnut.2023.02.017. Epub 2023 Feb 18.
- Individual participant dataSharing planned: Yes. De-identified data will 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. This study is not recruiting at the moment.
Stephanie B Jilcott Pitts, PhD principal investigator
East Carolina University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High carotenoid juice in people with Dietary Habits and Diet, Healthy, run by East Carolina University at 3 sites 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-week Change in Skin Carotenoid Status (time frame: Change in skin carotenoid status from baseline to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056624, which also lists 3 linked publications.
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 15 Jun 2023.