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

NCT ID: NCT02163928

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-14

Brief Summary

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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

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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

Conditions

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Health Behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Food-based intervention; increased fruits and vegetables

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

Intervention Type OTHER

Other Intervention Names

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Whole-diet intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Texas Tech University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathy Chauncey, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Locations

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Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18049555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20678465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20685953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23823930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20558286 (View on PubMed)

Other Identifiers

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CRI14-042 Skin Carotenoids

Identifier Type: OTHER

Identifier Source: secondary_id

L14-128

Identifier Type: -

Identifier Source: org_study_id

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