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

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ClinicalTrials.gov Identifier: NCT02163928
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment
Health Behavior Other: Food-based intervention; increased fruits and vegetables

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

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions
Actual Study Start Date : June 2014
Actual Primary Completion Date : December 14, 2016
Actual Study Completion Date : December 14, 2016

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


Primary Outcome Measures :
  1. Skin Carotenoid Scores (SCS) [ Time Frame: Baseline, 2,4,6,8,10,12 weeks ]
    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.


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Baseline, 2,4,6,8,10,12 weeks ]
    Weight will be measured on a calibrated balance scale. Subjects will remove shoes, keys, cellphones, or other objects from their person before being weighed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Medical students from Texas Tech University School of Medicine.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163928


Locations
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United States, Texas
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Kathy Chauncey, PhD, RDN Texas Tech University Health Sciences Center
Publications:
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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02163928    
Other Study ID Numbers: L14-128
CRI14-042 Skin Carotenoids ( Other Identifier: Clinical Research Institute )
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Keywords provided by Texas Tech University Health Sciences Center:
Antioxidants
Carotenoids
Diet