Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

NCT04056624 | Completed Results

• 1 other identifier: 1R01HL142544-01A1
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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.

Conditions

Dietary Habits; Diet, Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Low dose

EXPERIMENTAL

1 x 6 ounces of carotenoid-containing juice (6 mg carotenoids/6 oz)

Dietary Supplement: High carotenoid juice

High dose

EXPERIMENTAL

2 x 6 ounces of carotenoid-containing juice (12 mg carotenoids/12 oz)

Dietary Supplement: High carotenoid juice

Placebo

PLACEBO COMPARATOR

12 ounces of apple juice (negligible carotenoids 0.06 mg/12 oz)

Dietary Supplement: Placebo control - Apple juice

Interventions

High carotenoid juice DIETARY_SUPPLEMENT

Juice with high carotenoids

High dose; Low dose

Placebo control - Apple juice DIETARY_SUPPLEMENT

Juice with negligible carotenoids

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• East Carolina University: lead
• University of Minnesota: collaborator
• Baylor College of Medicine: collaborator

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 40654376 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.

  PMID: 37742797 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.

  PMID: 36804322 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Results Point of Contact

• Title: Stephanie Jilcott Pitts
• Organization: East Carolina University, Department of Public Health

jilcotts@ecu.edu

252-744-5572

Study Officials

• Stephanie B Jilcott Pitts, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 14, 2019
• Study Start: June 28, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (3)