Clinical trial NCT04056624: Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy
Official title: Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy as a Measure of Fruit and Vegetable Consumption in a Diverse Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Diet, Healthy
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Baylor College of Medicine
First posted: 2019-08-14
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: 3-week Change in Skin Carotenoid Status
timeFrame: Change in skin carotenoid status from baseline to 3 weeks
measure: 6-week Change in Skin Carotenoid Status
timeFrame: Change in skin carotenoid status from baseline to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: East Carolina University
name: Stephanie B Jilcott Pitts, PhD
role: PRINCIPAL_INVESTIGATOR
References: