NCT02163928

Brief Summary

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and vegetables to increase SCS in medical students. This will be an observational, non-invasive study examining skin carotenoid levels over time in individuals who have increased their intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per day over an eight week period of time. Students will self-select their fruits and vegetables from a given list and will receive supermarket gift cards to offset the cost of the increased food. Students will be asked to follow their usual diet for one week. Then increase their intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight weeks. Then return to their usual diet for 2 weeks. SCS scores will be taken at baseline and week 1. At the beginning of week 2, students will be asked to increase fruit and vegetable intake to 4-6 cups per day. SCS will be measured every two weeks during the 8-week intervention phase. Students will return to their usual diet for 2 weeks and SCS will be measured at the end of that 2-week period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2016

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

June 12, 2014

Last Update Submit

January 31, 2020

Conditions

Keywords

AntioxidantsCarotenoidsDiet

Outcome Measures

Primary Outcomes (1)

  • Skin Carotenoid Scores (SCS)

    Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. The purpose of this study is to measure changes in SCS in medical students when fruit and vegetable consumption is increased. SCS will measured using a Bio-photonic Scanner. This scanner non-invasively measures carotenoid levels in the skin using optical signals. By placing the palm of the hand in front of a low-energy blue light for less than two minutes, the scanner can determine the SCS.

    Baseline, 2,4,6,8,10,12 weeks

Secondary Outcomes (1)

  • Body weight

    Baseline, 2,4,6,8,10,12 weeks

Interventions

4-6 cups of fruits and vegetables daily for 8-weeks

Also known as: Whole-diet intervention

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical students from Texas Tech University School of Medicine.

You may qualify if:

  • Medical student from any year at Texas Tech University School of Medicine willing to maintain the increased consumption of fruits and vegetables for the entire eight-week experimental period, to maintain logs and to report at each of the times that measurements will be taken.

You may not qualify if:

  • Pregnancy
  • Smoker
  • BMI =/\> 30
  • Chronic disease such as diabetes, heart disease, or metabolic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (5)

  • Ermakov IV, Ermakova MR, McClane RW, Gellermann W. Resonance Raman detection of carotenoid antioxidants in living human tissues. Opt Lett. 2001 Aug 1;26(15):1179-81. doi: 10.1364/ol.26.001179.

    PMID: 18049555BACKGROUND
  • Ermakov IV, Gellermann W. Validation model for Raman based skin carotenoid detection. Arch Biochem Biophys. 2010 Dec 1;504(1):40-9. doi: 10.1016/j.abb.2010.07.023. Epub 2010 Aug 1.

    PMID: 20678465BACKGROUND
  • Mayne ST, Cartmel B, Scarmo S, Lin H, Leffell DJ, Welch E, Ermakov I, Bhosale P, Bernstein PS, Gellermann W. Noninvasive assessment of dermal carotenoids as a biomarker of fruit and vegetable intake. Am J Clin Nutr. 2010 Oct;92(4):794-800. doi: 10.3945/ajcn.2010.29707. Epub 2010 Aug 4.

    PMID: 20685953BACKGROUND
  • Mayne ST, Cartmel B, Scarmo S, Jahns L, Ermakov IV, Gellermann W. Resonance Raman spectroscopic evaluation of skin carotenoids as a biomarker of carotenoid status for human studies. Arch Biochem Biophys. 2013 Nov 15;539(2):163-70. doi: 10.1016/j.abb.2013.06.007. Epub 2013 Jun 30.

    PMID: 23823930BACKGROUND
  • Meinke MC, Darvin ME, Vollert H, Lademann J. Bioavailability of natural carotenoids in human skin compared to blood. Eur J Pharm Biopharm. 2010 Oct;76(2):269-74. doi: 10.1016/j.ejpb.2010.06.004. Epub 2010 Jun 15.

    PMID: 20558286BACKGROUND

MeSH Terms

Conditions

Health Behavior

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kathy Chauncey, PhD, RDN

    Texas Tech University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

June 1, 2014

Primary Completion

December 14, 2016

Study Completion

December 14, 2016

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations