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

NCT02464787 | Completed DMC

• 2 other identifiers: L15-148CRI 15-054
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior

Keywords

antioxidants; carotenoids; diet

Outcome Measures

Primary Outcomes (1)

• Change in skin carotenoid scores (SCS)

  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 Outcomes (1)

• Change in body weight

  12 weeks

Study Arms (1)

Medical Students

EXPERIMENTAL

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

Interventions

LifePak Nano DIETARY_SUPPLEMENT

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

Medical Students

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Related Publications (12)

• Baranowski T. Understanding the behavioral linkages needed for designing effective interventions to increase fruit and vegetable intake in diverse populations. J Am Diet Assoc. 2011 Oct;111(10):1472-5. doi: 10.1016/j.jada.2011.07.014. No abstract available.

  PMID: 21963012 BACKGROUND

• Dietary Guidelines for Americans, 2010; United States Department of Agriculture (USDA), United States Department of Health and Human Services: Dietary Guidelines for Americans, 2010. www.dietaryguidelines.gov

  BACKGROUND

• 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.

  PMID: 18049555 BACKGROUND

• Ermakov IV, Sharifzadeh M, Ermakova M, Gellermann W. Resonance Raman detection of carotenoid antioxidants in living human tissue. J Biomed Opt. 2005 Nov-Dec;10(6):064028. doi: 10.1117/1.2139974.

  PMID: 16409093 BACKGROUND

• 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.

  PMID: 20678465 BACKGROUND

• Institute of Medicine (US) Panel on Dietary Antioxidants and Related Compounds. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225483/

  PMID: 25077263 BACKGROUND

• Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.

  PMID: 25008856 BACKGROUND

• Krebs-Smith SM, Guenther PM, Subar AF, Kirkpatrick SI, Dodd KW. Americans do not meet federal dietary recommendations. J Nutr. 2010 Oct;140(10):1832-8. doi: 10.3945/jn.110.124826. Epub 2010 Aug 11.

  PMID: 20702750 BACKGROUND

• 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.

  PMID: 20685953 BACKGROUND

• 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.

  PMID: 23823930 BACKGROUND

• McKay DL, Perrone G, Rasmussen H, Dallal G, Hartman W, Cao G, Prior RL, Roubenoff R, Blumberg JB. The effects of a multivitamin/mineral supplement on micronutrient status, antioxidant capacity and cytokine production in healthy older adults consuming a fortified diet. J Am Coll Nutr. 2000 Oct;19(5):613-21. doi: 10.1080/07315724.2000.10718959.

  PMID: 11022875 BACKGROUND

• Scarmo S, Cartmel B, Lin H, Leffell DJ, Ermakov IV, Gellermann W, Bernstein PS, Mayne ST. Single v. multiple measures of skin carotenoids by resonance Raman spectroscopy as a biomarker of usual carotenoid status. Br J Nutr. 2013 Sep 14;110(5):911-7. doi: 10.1017/S000711451200582X. Epub 2013 Jan 28.

  PMID: 23351238 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Katherine B Chauncey, PhD, RDN

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 8, 2015
• Study Start: May 1, 2015
• Primary Completion: March 20, 2016
• Study Completion: October 14, 2016
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

US (1)