Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention (SCS2015)

August 12, 2020 updated by: Texas Tech University Health Sciences Center

Evaluation of Changes in Skin Carotenoid Score 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. BMI between 20 and 29.9
  3. Non-smoker, non-pregnant, non-lactating
  4. No use of tanning beds or sunless tanning products during the study

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Students
Medical students willing to maintain the increased consumption of LifePak Nano 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.
Dietary supplement: LifePak Nano
Two twin-sachet packets of seven (7) supplements twice per day, for the entire eight-week experimental period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Katherine B Chauncey, PhD, RDN, Texas Tech University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

March 20, 2016

Study Completion (Actual)

October 14, 2016

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • L15-148
  • CRI 15-054 (Other Identifier: TTUHSC Clinical Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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