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Efficacy of Solarplast for Health and Oxidative Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144777
Recruitment Status : Completed
First Posted : October 30, 2019
Last Update Posted : February 15, 2021
Sponsor:
Collaborator:
Kennesaw State University
Information provided by (Responsible Party):
Deerland Enzymes

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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Healthy Aging Skin Health Dietary Supplement: Solarplast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Efficacy of Solarplast for Health and Oxidative Stress, A Randomized, Double-Blind, Placebo-Controlled Study
Actual Study Start Date : July 15, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

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.



Primary Outcome Measures :
  1. Oxidative Stress [ Time Frame: 45 days ]
    Analyze change in reactive oxygen species obtained from blood from baseline to 45 days using reactive oxygen species testing kits

  2. Blood glucose [ Time Frame: 45 days ]
    Analyze change in fasting blood glucose obtained from blood from baseline to 45 days using metabolic panel

  3. Change in skin health using questionnaires [ Time Frame: 45 days ]
    Analyze skin health using questionnaires

  4. Change in joint pain using questionnaires [ Time Frame: 45 days ]
    Analyze change in joint pain using questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144777


Locations
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United States, Georgia
Kennesaw State University
Kennesaw, Georgia, United States, 30144
Sponsors and Collaborators
Deerland Enzymes
Kennesaw State University
Investigators
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Principal Investigator: Trisha VanDusseldorp, PhD Kennesaw State University
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Responsible Party: Deerland Enzymes
ClinicalTrials.gov Identifier: NCT04144777    
Other Study ID Numbers: SP19
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deerland Enzymes:
Smokers
Prediabetes
Cognitive Health