Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy (NCT04056624) | Clinical Trial Compass
CompletedNot Applicable
Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy
United States162 participantsStarted 2021-06-28
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3-week Change in Skin Carotenoid Status
Timeframe: Change in skin carotenoid status from baseline to 3 weeks
2
6-week Change in Skin Carotenoid Status
Timeframe: Change in skin carotenoid status from baseline to 6 weeks