Efficacy of Solarplast for Health and Oxidative Stress

Efficacy of Solarplast for Health and Oxidative Stress, A Randomized, Double-Blind, Placebo-Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging; Oxidative Stress; Skin Health
• Intervention / Treatment: Dietary supplement: Solarplast

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Kennesaw State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy smokers
• Healthy non-smokers
• Prediabetics (elevated fasting blood glucose of 100-125mg/dL).

Exclusion Criteria:

• No specific pulmonary disease
• No medication or specifically any inhaled bronchodilators or corticosteroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Subjects will be administered one daily dose of Solarplast (100mg), in a capsule, for 45 days.	Dietary supplement: Solarplast; Subjects will take one capsule of Solarplast (100mg) daily for 45 days.
No Intervention: Placebo; Subjects will be administered one daily dose of maltodextrin (100mg), in a capsule, for 45 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative Stress	Analyze change in reactive oxygen species obtained from blood from baseline to 45 days using reactive oxygen species testing kits	45 days
Blood glucose	Analyze change in fasting blood glucose obtained from blood from baseline to 45 days using metabolic panel	45 days
Change in skin health using questionnaires	Analyze skin health using questionnaires	45 days
Change in joint pain using questionnaires	Analyze change in joint pain using questionnaires	45 days

Collaborators and Investigators

• Sponsor: Deerland Enzymes
• Collaborators: Kennesaw State University
• Investigators: Principal Investigator: Trisha VanDusseldorp, PhD, Kennesaw State University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Prediabetes; Smokers; Cognitive Health
• Other Study ID Numbers: SP19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No