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

NCT ID: NCT02464787

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-10-14

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.

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.

Conditions

Health Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LifePak Nano

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

LifePak Nano

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine B Chauncey, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Locations

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Countries

United States

References

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Reference Type: BACKGROUND

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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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 18049555 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16409093 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20678465 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25077263 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

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Other Identifiers

CRI 15-054

Identifier Type: OTHER

Identifier Source: secondary_id

L15-148

Identifier Type: -

Identifier Source: org_study_id