N/A
N=162
Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy
Dietary Habits · Diet, Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04056624 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: 3-week Change in Skin Carotenoid Status — 28.0; 62.3; 9.34 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High carotenoid juice (Dietary_supplement); Placebo control - Apple juice (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- East Carolina University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3-week Change in Skin Carotenoid Status |
28.0; 62.3; 9.34 | — |
| PRIMARY 6-week Change in Skin Carotenoid Status |
59.0; 123; 11.9 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04056624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.