Efficacy of Solarplast for Health and Oxidative Stress
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2019
CompletedFirst Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFebruary 15, 2021
October 1, 2019
10 months
October 23, 2019
February 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Treatment
EXPERIMENTALSubjects will be administered one daily dose of Solarplast (100mg), in a capsule, for 45 days.
Placebo
NO INTERVENTIONSubjects will be administered one daily dose of maltodextrin (100mg), in a capsule, for 45 days.
Interventions
Subjects will take one capsule of Solarplast (100mg) daily for 45 days.
Eligibility Criteria
You may qualify if:
- Healthy smokers
- Healthy non-smokers
- Prediabetics (elevated fasting blood glucose of 100-125mg/dL).
You may not qualify if:
- No specific pulmonary disease
- No medication or specifically any inhaled bronchodilators or corticosteroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deerland Enzymeslead
- Kennesaw State Universitycollaborator
Study Sites (1)
Kennesaw State University
Kennesaw, Georgia, 30144, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trisha VanDusseldorp, PhD
Kennesaw State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
October 30, 2019
Study Start
July 15, 2019
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
February 15, 2021
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share