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

Smoking, Cigarette Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Immunity
• Smoking, Cigarette

• NCT number: NCT05162820
• Study type: Interventional
• Source: University of Memphis
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Completion date: August 24, 2023