Clinical trial NCT02464787: Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention
Official title: Evaluation of Changes in Skin Carotenoid Score in Medical Students Following a Dietary Supplement-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: antioxidants
carotenoids
diet
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Change in skin carotenoid scores (SCS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Katherine B Chauncey, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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