Clinical trial NCT02163928: Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions
Official title: Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Keywords: Antioxidants
Carotenoids
Diet
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students from Texas Tech University School of Medicine.

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.

Detailed description: Inclusion criteria:

* Medical students (any year) from Texas Tech School of Medicine
* BMI between 20-29
* Non-smoker, non-pregnant

Exclusion criteria:

* Individuals suffering from a chronic disease such as diabetes, heart disease, or other metabolic disorder
* Pregnant women
* Smokers
* Individuals with BMI \> or = 30 or \< or = 19

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Skin Carotenoid Scores (SCS)
timeFrame: Baseline, 2,4,6,8,10,12 weeks
Secondary outcomes:
measure: Body weight
timeFrame: Baseline, 2,4,6,8,10,12 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Kathy Chauncey, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.