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Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

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ClinicalTrials.gov Identifier: NCT04056624
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 24, 2021
Sponsor:
Collaborators:
University of Minnesota
Baylor College of Medicine
Information provided by (Responsible Party):
Stephanie Pitts, East Carolina University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Dietary Habits Diet, Healthy Dietary Supplement: High carotenoid juice Dietary Supplement: Placebo control - Apple juice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy as a Measure of Fruit and Vegetable Consumption in a Diverse Community
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Low dose
1 x 6 ounces of carotenoid-containing juice (6 mg carotenoids/6 oz)
Dietary Supplement: High carotenoid juice
Juice with high carotenoids

Experimental: High dose
2 x 6 ounces of carotenoid-containing juice (12 mg carotenoids/12 oz)
Dietary Supplement: High carotenoid juice
Juice with high carotenoids

Placebo Comparator: Placebo
12 ounces of apple juice (negligible carotenoids 0.06 mg/12 oz)
Dietary Supplement: Placebo control - Apple juice
Juice with negligible carotenoids




Primary Outcome Measures :
  1. Skin carotenoid status [ Time Frame: Change in skin carotenoid status from baseline to 3 weeks ]
    Assessed using the Veggie Meter

  2. Skin carotenoid status [ Time Frame: Change in skin carotenoid status from baseline to 6 weeks ]
    Assessed using the Veggie Meter


Secondary Outcome Measures :
  1. Plasma carotenoid status [ Time Frame: Change in plasma carotenoids from baseline to 3 weeks ]
    Assessed using high performance liquid chromatography

  2. Plasma carotenoid status [ Time Frame: Change in plasma carotenoids from baseline to 6 weeks ]
    Assessed using high performance liquid chromatography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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).

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056624


Contacts
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Contact: Stephanie B Jilcott Pitts, PhD 252-44-5572 jilcotts@ecu.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Stacey Moe    612-626-8607    gerl0056@umn.edu   
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Stephanie Pitts, PhD    252-744-5572    jilcotts@ecu.edu   
Contact: Elizabeth Gates, MPH    252-744-2952    gatese21@ecu.edu   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Nancy Moran, PhD    713-798-0520    Nancy.Moran@bcm.edu   
Contact: Jocelyn Chang       Jocelyn.Chang@bcm.edu   
Sponsors and Collaborators
East Carolina University
University of Minnesota
Baylor College of Medicine
Investigators
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Principal Investigator: Stephanie B Jilcott Pitts, PhD East Carolina University
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Responsible Party: Stephanie Pitts, Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT04056624    
Other Study ID Numbers: 1R01HL142544-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available to share with other investigators 12 months after study completion.
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs