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Efficacy of Solarplast for Health and Oxidative Stress

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144777
Enrollment
84
Registered
2019-10-30
Start date
2019-07-15
Completion date
2020-05-01
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging, Oxidative Stress, Skin Health

Keywords

Smokers, Prediabetes, Cognitive Health

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.

Interventions

DIETARY_SUPPLEMENTSolarplast

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

Sponsors

Kennesaw State University
CollaboratorOTHER
Deerland Enzymes
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxidative Stress45 daysAnalyze change in reactive oxygen species obtained from blood from baseline to 45 days using reactive oxygen species testing kits
Blood glucose45 daysAnalyze change in fasting blood glucose obtained from blood from baseline to 45 days using metabolic panel
Change in skin health using questionnaires45 daysAnalyze skin health using questionnaires
Change in joint pain using questionnaires45 daysAnalyze change in joint pain using questionnaires

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026