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Completed

NCT Number: NCT02163928

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

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food-based intervention; increased fruits and vegetables

Other

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

Other names: Whole-diet intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2014
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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