Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions

Health Behavior Clinical Trial

Official title:

Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163928
• Other study ID #: L14-128
• Secondary ID: CRI14-042 Skin C
• Status: Completed
• Start date: June 2014
• Est. completion date: December 14, 2016

Study information

• Verified date: January 2020
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 14, 2016
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Other:
• Food-based intervention; increased fruits and vegetables
4-6 cups of fruits and vegetables daily for 8-weeks

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body weight	Weight will be measured on a calibrated balance scale. Subjects will remove shoes, keys, cellphones, or other objects from their person before being weighed.	Baseline, 2,4,6,8,10,12 weeks