The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. The hypothesis is that the Solarplast treatment will reduce oxidative stress biomarkers and favorably impact immune measures and both perceived and quantifiable measures of skin health, in both smokers and non-smokers, with a greater impact observed in smokers. Photographic analyses like the Pear Plus 3D system have been developed for clinical use for monitoring skin health.
Deerland Probiotics and Enzymes has developed a dietary supplement called Solarplast®, which is an organic spinach extract, currently being sold on the market (Solarplast - Deerland Probiotics and Enzymes). It contains a unique mixture of antioxidant enzymes and single antioxidant molecules that work to attack reactive oxygen species (ROS) through chaperone activity. These chaperones are naturally occurring proteins that provide protection from stress, such as ROS, heat, and infection, and can lead to reduced inflammation and alteration in immune function. Spinach is rich in select vitamins and minerals, such as iron, vitamin A, riboflavin, and lutein-a carotenoid that acts as a natural antioxidant, protecting the body from toxins and ROS. Solarplast is thought to exhibit antioxidant protection against ROS, while also containing photosynthetic complexes with high concentrations of ATP, NADPH, ADP, AMP, NADP, niacin, B12, adenine, and ribose. Therefore, it may provide the components required to scavenge free radicals and mitigate ensuing damage from ROS. In living cells, ROS such as singlet oxygen (·O), superoxide radical (O2· -), and hydroxyl radical (·OH) are continuously formed as a consequence of normal cellular metabolism and are increased under conditions of environmental stress. Production of ROS in quantities that overwhelm the endogenous antioxidant defense system leads to oxidative stress, and this oxidative stress is strongly linked to the pathogenesis of numerous diseases, including diabetes, cancer, and cardiovascular disease. Oxidative stress leads to increases in proinflammatory cytokines such as IL-1B and TNF-alpha. Lipopolysaccharide (LPS) can induce ROS and proinflammatory cytokines. Antioxidants present in spinach may provide some protection against LPS actions. It is well known that cigarette smoking exacerbates ROS formation and poses a significant pro-oxidant stress in vivo. In one puff of a cigarette, the smoker is exposed to \>1015 free radicals in the gas phase alone, with additional exposure in the tar phase equal to \>1017 free radicals·g-1. This direct exposure represents only a fraction of the total oxidative stress experienced, as cigarette smoke contributes to further endogenous ROS production mediated through inflammatory and immune processes. ROS formation due to cigarette smoking is thought to contribute to premature skin aging . Carotenoids like lutein in spinach, are believed to help protect skin from this ROS damage. Therefore, treating smokers with antioxidant therapy may not only alter immune function and measures of oxidative stress, but also prove helpful to both perceptions and measures of skin health. Antioxidant supplementation can also reduce oxidative stress, which is linked to cognitive/mental health. Those who are exposed to high levels of oxidants and who are in a chronic state of oxidative stress (e.g., smokers) may be more susceptible to impaired mental health. A previous clinical research trial evaluating Solarplast titled "Efficacy of Solarplast for Health and Oxidative Stress, A Randomized, Double-Blind, Placebo-Controlled Study" noted improved antioxidant defense and immunity, as well as improved subjective feelings of health (e.g., decreased irritability, decreased tension and anxiety), and improved self-reported skin health in a sample of smokers and non-smokers. The present study seeks to extend these findings in a larger sample of smokers. The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. We hypothesize that the Solarplast treatment will reduce oxidative stress biomarkers and favorably impact immune measures and both perceived and quantifiable measures of skin health, in both smokers and non-smokers, with a greater impact observed in smokers. Smoking, causes a decrease in blood flow to skin and dryness along with other adverse effects that can prematurely age skin. As quantifiable measures provide more sound evidence than personal perceptions when evaluating skin treatments, there has been a greater push for more analytical methods in the assessment of skin regimens which include topographical, pigmentation, color, as well as other measures that will be employed in this study via photographical image analysis of subject's facial skin. Photographic analyses like the Pear Plus 3D system have been developed for clinical use for monitoring skin health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
50
100 mg Solarplast delivered in capsules with the carrier of rice dextrin and medium chain triglycerides consumed daily at breakfast for 60 days
rice dextrin and medium chain triglycerides in capsules consumed daily at breakfast for 60 days
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, United States
Plasma Cytokine Panel
Cytokines analyzed from plasma for IL-1beta, IL-6, IL-10, and TNF-alpha
Time frame: baseline
Plasma Cytokine Panel
Plasma analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Time frame: after 30 days of treatment
Plasma Cytokine Panel
Plasama analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Time frame: after 60 days of treatment
Plasma Cytokine Panel on LPS treated whole blood
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Time frame: baseline
Plasma Cytokine Panel on LPS treated whole blood
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Time frame: after 30 days of treatment
Plasma Cytokine Panel on LPS treated whole blood
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Time frame: after 60 days of treatment
Protein oxidation
Blood sample analyzed for protein oxidation
Time frame: baseline
Protein oxidation
Blood sample analyzed for protein oxidation
Time frame: after 30 days of treatment
Protein oxidation
Blood sample analyzed for protein oxidation
Time frame: after 60 days of treatment
Lipid peroxidation
Blood sample analyzed for lipid peroxidation
Time frame: baseline
Lipid peroxidation
Blood sample analyzed for lipid peroxidation
Time frame: after 30 days of treatment
Lipid peroxidation
Blood sample analyzed for lipid peroxidation
Time frame: after 60 days of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: baseline
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 1 week of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 2 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 3 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 4 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 5 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 6 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 7 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Time frame: 8 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: baseline
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 1 week of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 2 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 3 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 4 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 5 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 6 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 7 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Time frame: 8 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: baseline
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 1 week of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 2 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 3 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 4 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 5 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 6 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 7 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Time frame: 8 weeks of treatment
Quantitative Skin measures
A skin report will generated using the 3D Pear Plus system
Time frame: baseline
Quantitative Skin measures
A skin report will generated using the 3D Pear Plus system
Time frame: 30 days of treatment
Quantitative Skin measures
A skin report will generated using the 3D Pear Plus system
Time frame: 60 days of treatment
Food Logs
Dietary intake will be reported for the 5 days prior to the study visit
Time frame: baseline
Food Logs
Dietary intake will be reported for the 5 days prior to the study visit
Time frame: 30 days of treatment
Food Logs
Dietary intake will be reported for the 5 days prior to the study visit
Time frame: 60 days of treatment
Resting blood pressure
Blood pressure will be measured following a 10 minute rest
Time frame: baseline
Resting blood pressure
Blood pressure will be measured following a 10 minute rest
Time frame: 30 days of treatment
Resting blood pressure
Blood pressure will be measured following a 10 minute rest
Time frame: 60 days of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.