Efficacy of Solarplast for Health and Oxidative Stress
Condition: Oxidative Stress; Healthy Aging; Skin Health
Study type: Interventional

Summary: 
      Solarplast is a unique mixture of antioxidant enzymes and single antioxidant molecules that
      are capable of attack oxidants that cause damage to the cells in the human body and cause
      premature aging. This mechanism may provide protection from stress, such as free radicals,
      heat, infection, as well as reduce inflammation and participate in the repair mechanism of
      the intestinal tract. Participants will consume Solarplast, or placebo, for 45 days with
      blood draws at day-0 and -45 in order to assess antioxidant capacity.
    

Detailed description: 
      Solarplast is currently sold on the market, which is a unique mixture of antioxidant enzymes
      and single antioxidant molecules that attack oxidants through chaperone activity. Chaperones,
      are naturally occurring proteins that assist the non-covalent folding/unfolding and the
      assembly/disassembly of other macromolecular structures and can provide stability and restore
      function of many unfolded proteins. Chaperones may provide protection from stress, such as
      free radicals, heat, infection, as well as reduce inflammation and participate in the repair
      mechanism of the intestinal tract. Solarplast is derived from Spinach (Spinacia oleracea), a
      leafy green vegetable of high nutritional value grown and consumed worldwide. Spinach is rich
      in iron, vitamin A, riboflavin, and lutein, a carotenoid that acts as a natural antioxidant
      protecting the body from toxins and free radicals. The potential mechanistic role of
      Solarplast consists of serving an antioxidant role against peroxyl radicals, hydroxyl
      radicals, peroxynitrite, super oxide anion, singlet oxygen, among others. Additionally,
      Solarplast contains photosynthetic complexes with high concentrations of ATP, NADPH, ADP,
      AMP, NADP, niacin, B12, adenine, and ribose. Therefore, this naturally occurring antioxidant
      supplement may provide the components required to scavenge free radicals and mitigate
      oxidative stress with no harmful side effects.

      The purpose of this study is to determine the antioxidant and health effects of Solarplast in
      40 healthy human subjects, 20 smokers, and 20 pre-diabetics; both male and female (n=80). An
      equal number of males and females will be recruited for the project. Only participants
      between the ages of 18 and 55 will be recruited for this research. Smokers and pre-diabetics
      are known to have increased oxidative stress; therefore, these two populations are being
      included in this research.

      A single capsule of Solarplast containing 100 mg (1 x 10^6 light converting units (LCU)) is
      to be consumed once a day per participant for a total of 45 days, following pre-screening and
      enrollment (detailed below). Twenty healthy (of the 40 healthy) human subjects will be used
      as control subjects and consume a placebo (maltodextrin - 100 mg).

      A medical doctor will approve the enrollment (Dr. Karleena Tuggle) of all participants and
      oversee this clinical trial.

      Participants will be asked to visit the laboratory (KSU Human Performance Laboratory) on 2
      separate occasions for blood draws by a CITI approved/IRB approved research team member
      trained in phlebotomy under the supervision of Dr. VanDusseldorp.
    

Intervention name(s): Solarplast
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will take one capsule of Solarplast (100mg) daily for 45 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Smokers; Prediabetes; Cognitive Health