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Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

Primary Purpose

Dietary Habits, Diet, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High carotenoid juice
Placebo control - Apple juice
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dietary Habits

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Minnesota
  • East Carolina University
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose

High dose

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2019
Last Updated
May 22, 2023
Sponsor
East Carolina University
Collaborators
University of Minnesota, Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04056624
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
Collaborators
University of Minnesota, Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Habits, Diet, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
1 x 6 ounces of carotenoid-containing juice (6 mg carotenoids/6 oz)
Arm Title
High dose
Arm Type
Experimental
Arm Description
2 x 6 ounces of carotenoid-containing juice (12 mg carotenoids/12 oz)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 ounces of apple juice (negligible carotenoids 0.06 mg/12 oz)
Intervention Type
Dietary Supplement
Intervention Name(s)
High carotenoid juice
Intervention Description
Juice with high carotenoids
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo control - Apple juice
Intervention Description
Juice with negligible carotenoids
Primary Outcome Measure Information:
Title
3-week Change in Skin Carotenoid Status
Description
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.
Time Frame
Change in skin carotenoid status from baseline to 3 weeks
Title
6-week Change in Skin Carotenoid Status
Description
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.
Time Frame
Change in skin carotenoid status from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie B Jilcott Pitts, PhD
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared with other researchers.
IPD Sharing Time Frame
Data will be available to share with other investigators 12 months after study completion.
IPD Sharing Access Criteria
Researchers must submit a plan for analysis, obtain Institutional Review Board approval and be approved by study investigators before data are released.

Learn more about this trial

Examining Validity and Sensitivity of Pressure-Mediated Reflection Spectroscopy

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