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Completed

NCT Number: NCT02464787

Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in subjects who increased their intake of fruits and vegetables. The scores were determined using the Raman Spectroscopy. In that study subjects were assigned to one of four groups based on their baseline SCS. For unknown reasons, the groups with the highest and lowest baseline SCS failed to show an increase whereas the two intermediate groups did. One possible explanation might be that intakes varied more than expected and was not obvious due to self-reporting of intake of fruits and vegetables with different contents.

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Key information

Conditions

Health Behavior Behavior

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

About this study

This current project will be an interventional, non-invasive study examining changes in skin carotenoid levels over time in individuals who increase their carotenoid intake by taking a dietary supplement containing a known amount of carotenoids. After a two-week control period eating their normal diet, forty medical students meeting study inclusion criteria will be asked to take a dietary supplement over an eight week period of time. Students will be given twin-sachet packets of LifePak Nano supplements containing five capsules (dry ingredients) and two CR-6 Liponutrient softgel capsules (liquid ingredients, including omega-3 fatty acids and nanosized carotenoids). These will be taken twice a day with eight ounces of liquid at the morning and evening meal. SCS will be measured every 2 weeks. At the end of this period, the students will be asked to discontinue dietary supplement intake and follow their usual diet for 2 weeks then their SCS measured again.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Medical students must be willing to maintain the increased consumption of dietary supplements, two twin-sachet packets of seven (7) supplements twice per day, for the entire eight-week experimental period, to maintain the logs and to report at each of the times that measurements will be made. Individuals taking non-Pharmanex dietary supplements e.g. vitamins, minerals, herbals, and/or antioxidants will be asked to discontinue use at the time of the consenting to the study. Study supplements will replace all previous dietary supplements.
  • BMI between 20 and 29.9
  • Non-smoker, non-pregnant, non-lactating
  • No use of tanning beds or sunless tanning products during the study

Exclusion criteria

  • Prior participation in the previous study (L14 -128)
  • Individuals suffering from any chronic illness requiring ongoing medication, such as diabetes, hypertension, heart disease, GI disorders or other metabolic disorders
  • Individuals allergic or intolerant to shellfish,
  • pregnant or lactating women,
  • smokers
  • individuals with BMI > 30
  • Prior ingestion of LifePak Nano or other Pharmanex dietary supplements within the past 3 months.
  • SCS score less than 10,000 (< 10,000)

Treatment and study plan

LifePak Nano

Dietary Supplement

Two twin-sachet packets of seven (7) supplements twice per day, for the entire eight-week experimental period.

Primary outcomes

  1. Change in skin carotenoid scores (SCS)

    Time frame: 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 taking dietary supplements over a 12-week period of time. 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. Change in body weight

    Time frame: 12 weeks

    Weight will be measured on a calibrated balance scale over a 12-week period of time. 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

Official study title

Evaluation of Changes in Skin Carotenoid Score in Medical Students Following a Dietary Supplement-based Intervention

Acronym: SCS2015

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2015
Registry last updated
Aug 14, 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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