Impact of Solarplast® on Immunity in Active Smokers and Non-smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Solarplast® on Immunity in Active Smokers and Non-smokers

Conditions
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Immunity, Smoking, Cigarette

Intervention / Treatment
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* Dietary Supplement: 100 mg Solarplast
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) between 18-40 kg/m2 (not morbidly obese) if a smoker, smokes at least 5 cigarettes per day for the past 12 months if a smoker, experience occasional mild skin irritations (e.g., rash, dryness, redness, itching, etc.) if non-smoker, not have used tobacco products or any smoked product (e.g., marijuana, cigar, pipe) in the past 12 months if non-smoker, not exposed to regular second-hand smoke (e.g., lives with or works in close proximity to a smoker) no consumption of alcohol-containing beverages within 48 hours of testing no consumption of caffeine-containing beverages within 24 hours of testing without active infection or illness of any kind if female, not be pregnant able to fast overnight (10-12 hours) Not have doctor prescribed immune function or antioxidant nutritional supplements, over the counter medications, or prescription drugs that might impact outcomes (e.g. Vitamin-C, elderberry, ginger, turmeric, quercetin, supplements with Immun or have immunity on their label, Immunosuppressives: prednisolone, Azathioprine, Mycophenolate mofetil, Monoclonal antibodies - of which there are many ending in mab, such as bevacizumab, rituximab and trastuzumab, Anti-TNF drugs such as etanercept, infliximab, adalimumab, certolizumab and golimumab, Methotrexate, Ciclosporin, Tacrolimus, Sirolimus, Cyclophosphamide, Leflunomide, Immunotherapies: Immune Checkpoint Inhibitors, Adoptive Cell Therapies, Monoclonal Antibodies, Oncolytic Virus Therapy, Immune System Modulators, etc.) be willing to stop non-prescribed immune function or antioxidant nutritional supplements and over the counter medications (e.g. Vitamin-C, elderberry, ginger, turmeric, quercetin, supplements with Immun or have immunity on their label, etc.) one month prior to and through the duration of the study Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo-Controlled Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoker Solarplast<br>Smoker's assigned to solarplast | Dietary Supplement: 100 mg Solarplast<br>* 100 mg Solarplast delivered in capsules with the carrier of rice dextrin and medium chain triglycerides consumed daily at breakfast for 60 days<br>|
| Placebo Comparator: Smoker Placebo<br>Smoker's assigned to placebo | Dietary Supplement: Placebo<br>* rice dextrin and medium chain triglycerides in capsules consumed daily at breakfast for 60 days<br>|
| Experimental: Non-smoker Solarplast<br>Non-smoker assigned to solarplast | Dietary Supplement: 100 mg Solarplast<br>* 100 mg Solarplast delivered in capsules with the carrier of rice dextrin and medium chain triglycerides consumed daily at breakfast for 60 days<br>|
| Placebo Comparator: Non-smoker Placebo<br>Non-smoker assigned to placebo | Dietary Supplement: Placebo<br>* rice dextrin and medium chain triglycerides in capsules consumed daily at breakfast for 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Cytokine Panel | Cytokines analyzed from plasma for IL-1beta, IL-6, IL-10, and TNF-alpha | baseline | 
| Plasma Cytokine Panel | Plasma analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha | after 30 days of treatment | 
| Plasma Cytokine Panel | Plasama analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha | 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 | baseline | 
| Plasma Cytokine Panel on LPS treated whole blood | LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha | 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 | after 60 days of treatment | 
| Protein oxidation | Blood sample analyzed for protein oxidation | baseline | 
| Protein oxidation | Blood sample analyzed for protein oxidation | after 30 days of treatment | 
| Protein oxidation | Blood sample analyzed for protein oxidation | after 60 days of treatment | 
| Lipid peroxidation | Blood sample analyzed for lipid peroxidation | baseline | 
| Lipid peroxidation | Blood sample analyzed for lipid peroxidation | after 30 days of treatment | 
| Lipid peroxidation | Blood sample analyzed for lipid peroxidation | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 8 weeks of treatment | 
| Quantitative Skin measures | A skin report will generated using the 3D Pear Plus system | baseline | 
| Quantitative Skin measures | A skin report will generated using the 3D Pear Plus system | 30 days of treatment | 
| Quantitative Skin measures | A skin report will generated using the 3D Pear Plus system | 60 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Logs | Dietary intake will be reported for the 5 days prior to the study visit | baseline | 
| Food Logs | Dietary intake will be reported for the 5 days prior to the study visit | 30 days of treatment | 
| Food Logs | Dietary intake will be reported for the 5 days prior to the study visit | 60 days of treatment | 
| Resting blood pressure | Blood pressure will be measured following a 10 minute rest | baseline | 
| Resting blood pressure | Blood pressure will be measured following a 10 minute rest | 30 days of treatment | 
| Resting blood pressure | Blood pressure will be measured following a 10 minute rest | 60 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinach, Solarplast, Skin Health