Efficacy of Solarplast for Health and Oxidative Stress

NCT ID: NCT04144777

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2020-05-01

Brief 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.

Conditions

Oxidative Stress; Healthy Aging; Skin Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

Subjects will be administered one daily dose of Solarplast (100mg), in a capsule, for 45 days.

Group Type: EXPERIMENTAL

Solarplast

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take one capsule of Solarplast (100mg) daily for 45 days.

Placebo

Subjects will be administered one daily dose of maltodextrin (100mg), in a capsule, for 45 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Solarplast

Subjects will take one capsule of Solarplast (100mg) daily for 45 days.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kennesaw State University

OTHER

Sponsor Role: collaborator

Deerland Enzymes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trisha VanDusseldorp, PhD

Role: PRINCIPAL_INVESTIGATOR

Kennesaw State University

Locations

Kennesaw State University

Kennesaw, Georgia, United States

Countries

United States

Other Identifiers

SP19

Identifier Type: -

Identifier Source: org_study_id