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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| Baylor College of Medicine | OTHER |
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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.](streamdown:incomplete-link)
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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | 1 x 6 ounces of carotenoid-containing juice (6 mg carotenoids/6 oz) |
|
| High dose | Experimental | 2 x 6 ounces of carotenoid-containing juice (12 mg carotenoids/12 oz) |
|
| Placebo | Placebo Comparator | 12 ounces of apple juice (negligible carotenoids 0.06 mg/12 oz) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High carotenoid juice | Dietary Supplement | Juice with high carotenoids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change in skin carotenoid status from baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie B Jilcott Pitts, PhD | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States | ||
| East Carolina University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40654376 | Derived | 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. | |
| 37742797 | Derived | Jilcott 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. |
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De-identified data will be shared with other researchers.
Data will be available to share with other investigators 12 months after study completion.
Researchers must submit a plan for analysis, obtain Institutional Review Board approval and be approved by study investigators before data are released.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | 1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids |
| FG001 | High Dose | 2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids |
| FG002 | Placebo | 6 ounces of apple juice (negligible carotenoids 0.03 mg/6oz) Placebo control - Apple juice: Juice with negligible carotenoids |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | 1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids |
| BG001 | High Dose | 2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change in skin carotenoid status from baseline to 3 weeks |
|
The time frame was through 6-weeks, or over the study duration for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | 1 x 6 ounces of carotenoid-containing juice (4 mg carotenoids/6 oz) High carotenoid juice: Juice with high carotenoids |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Jilcott Pitts | East Carolina University, Department of Public Health | 252-744-5572 | jilcotts@ecu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2021 | Apr 26, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2021 | Apr 28, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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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).](streamdown:incomplete-link)
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| Placebo control - Apple juice |
| Dietary Supplement |
Juice with negligible carotenoids |
|
| Greenville |
| North Carolina |
| 27834 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| 36804322 | Derived | Jilcott 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. |
| BG002 | Placebo | 6 ounces of apple juice (negligible carotenoids 0.03 mg/6 oz) Placebo control - Apple juice: Juice with negligible carotenoids |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Skin Carotenoid Level | 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. | Mean | Standard Deviation | units on a scale |
|
| High Dose |
2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids |
| OG002 | Placebo | 6 ounces of apple juice (negligible carotenoids 0.03 mg/6 oz) Placebo control - Apple juice: Juice with negligible carotenoids |
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Change in skin carotenoid status from baseline to 6 weeks |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | High Dose | 2 x 6 ounces of carotenoid-containing juice (8 mg carotenoids/12 oz) High carotenoid juice: Juice with high carotenoids | 0 | 54 | 0 | 54 | 0 | 54 |
| EG002 | Placebo | 6 ounces of apple juice (negligible carotenoids 0.03 mg/6 oz) Placebo control - Apple juice: Juice with negligible carotenoids | 0 | 52 | 0 | 52 | 0 | 52 |
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