Impact of Solarplast® on Immunity in Active Smokers and Non-smokers
Condition: Immunity; Smoking, Cigarette
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): 100 mg Solarplast; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Solarplast; Spinach; Skin Health