ImmunityNCT05162820
Impact of Solarplast® on Immunity in Active Smokers and Non-smokers
A study testing 100 mg Solarplast in people with Immunity and Smoking, Cigarette, run by University of Memphis at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity, Smoking, Cigarette
- What is being tested?
- 100 mg Solarplast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) between 18-40 kg/m2 (not morbidly obese)
- if a smoker, smokes at least 5 cigarettes per day for the past 12 months
- if a smoker, experience occasional mild skin irritations (e.g., rash, dryness, redness, itching, etc.)
- if non-smoker, not have used tobacco products or any smoked product (e.g., marijuana, cigar, pipe) in the past 12 months
- if non-smoker, not exposed to regular second-hand smoke (e.g., lives with or works in close proximity to a smoker)
- no consumption of alcohol-containing beverages within 48 hours of testing
Show all 12Show fewer
- no consumption of caffeine-containing beverages within 24 hours of testing
- without active infection or illness of any kind
- if female, not be pregnant
- able to fast overnight (10-12 hours)
- Not have doctor prescribed immune function or antioxidant nutritional supplements, over the counter medications, or prescription drugs that might impact outcomes (e.g. Vitamin-C, elderberry, ginger, turmeric, quercetin, supplements with "Immun" or have immunity on their label, Immunosuppressives: prednisolone, Azathioprine, Mycophenolate mofetil, Monoclonal antibodies - of which there are many ending in "mab", such as bevacizumab, rituximab and trastuzumab, Anti-TNF drugs such as etanercept, infliximab, adalimumab, certolizumab and golimumab, Methotrexate, Ciclosporin, Tacrolimus, Sirolimus, Cyclophosphamide, Leflunomide, Immunotherapies: Immune Checkpoint Inhibitors, Adoptive Cell Therapies, Monoclonal Antibodies, Oncolytic Virus Therapy, Immune System Modulators, etc.)
- be willing to stop non-prescribed immune function or antioxidant nutritional supplements and over the counter medications (e.g. Vitamin-C, elderberry, ginger, turmeric, quercetin, supplements with "Immun" or have immunity on their label, etc.) one month prior to and through the duration of the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. The hypothesis is that the Solarplast treatment will reduce oxidative stress biomarkers and favorably impact immune measures and both perceived and quantifiable measures of skin health, in both smokers and non-smokers, with a greater impact observed in smokers. Photographic analyses like the Pear Plus 3D system have been developed for clinical use for monitoring skin health.
Read the detailed description
Deerland Probiotics and Enzymes has developed a dietary supplement called Solarplast®, which is an organic spinach extract, currently being sold on the market (Solarplast - Deerland Probiotics and Enzymes). It contains a unique mixture of antioxidant enzymes and single antioxidant molecules that work to attack reactive oxygen species (ROS) through chaperone activity. These chaperones are naturally occurring proteins that provide protection from stress, such as ROS, heat, and infection, and can lead to reduced inflammation and alteration in immune function.
Spinach is rich in select vitamins and minerals, such as iron, vitamin A, riboflavin, and lutein-a carotenoid that acts as a natural antioxidant, protecting the body from toxins and ROS. Solarplast is thought to exhibit antioxidant protection against ROS, while also containing photosynthetic complexes with high concentrations of ATP, NADPH, ADP, AMP, NADP, niacin, B12, adenine, and ribose. Therefore, it may provide the components required to scavenge free radicals and mitigate ensuing damage from ROS.
In living cells, ROS such as singlet oxygen (·O), superoxide radical (O2· -), and hydroxyl radical (·OH) are continuously formed as a consequence of normal cellular metabolism and are increased under conditions of environmental stress. Production of ROS in quantities that overwhelm the endogenous antioxidant defense system leads to oxidative stress, and this oxidative stress is strongly linked to the pathogenesis of numerous diseases, including diabetes, cancer, and cardiovascular disease.
Oxidative stress leads to increases in proinflammatory cytokines such as IL-1B and TNF-alpha. Lipopolysaccharide (LPS) can induce ROS and proinflammatory cytokines. Antioxidants present in spinach may provide some protection against LPS actions.
It is well known that cigarette smoking exacerbates ROS formation and poses a significant pro-oxidant stress in vivo. In one puff of a cigarette, the smoker is exposed to >1015 free radicals in the gas phase alone, with additional exposure in the tar phase equal to >1017 free radicals·g-1. This direct exposure represents only a fraction of the total oxidative stress experienced, as cigarette smoke contributes to further endogenous ROS production mediated through inflammatory and immune processes. ROS formation due to cigarette smoking is thought to contribute to premature skin aging . Carotenoids like lutein in spinach, are believed to help protect skin from this ROS damage. Therefore, treating smokers with antioxidant therapy may not only alter immune function and measures of oxidative stress, but also prove helpful to both perceptions and measures of skin health.
Antioxidant supplementation can also reduce oxidative stress, which is linked to cognitive/mental health. Those who are exposed to high levels of oxidants and who are in a chronic state of oxidative stress (e.g., smokers) may be more susceptible to impaired mental health.
A previous clinical research trial evaluating Solarplast titled "Efficacy of Solarplast for Health and Oxidative Stress, A Randomized, Double-Blind, Placebo-Controlled Study" noted improved antioxidant defense and immunity, as well as improved subjective feelings of health (e.g., decreased irritability, decreased tension and anxiety), and improved self-reported skin health in a sample of smokers and non-smokers. The present study seeks to extend these findings in a larger sample of smokers.
The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. We hypothesize that the Solarplast treatment will reduce oxidative stress biomarkers and favorably impact immune measures and both perceived and quantifiable measures of skin health, in both smokers and non-smokers, with a greater impact observed in smokers. Smoking, causes a decrease in blood flow to skin and dryness along with other adverse effects that can prematurely age skin. As quantifiable measures provide more sound evidence than personal perceptions when evaluating skin treatments, there has been a greater push for more analytical methods in the assessment of skin regimens which include topographical, pigmentation, color, as well as other measures that will be employed in this study via photographical image analysis of subject's facial skin. Photographic analyses like the Pear Plus 3D system have been developed for clinical use for monitoring skin health.
- Conditions
- Immunity, Smoking, Cigarette
- Being tested
- 100 mg Solarplast, Placebo
- Keywords
- Solarplast, Spinach, Skin Health
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 mg SolarplastDietary supplement
100 mg Solarplast delivered in capsules with the carrier of rice dextrin and medium chain triglycerides consumed daily at breakfast for 60 days
PlaceboDietary supplement
rice dextrin and medium chain triglycerides in capsules consumed daily at breakfast for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Smoker Solarplast | Experimental | Smoker's assigned to solarplast Receives: Dietary Supplement: 100 mg Solarplast |
| Smoker Placebo | Placebo comparator | Smoker's assigned to placebo Receives: Dietary Supplement: Placebo |
| Non-smoker Solarplast | Experimental | Non-smoker assigned to solarplast Receives: Dietary Supplement: 100 mg Solarplast |
| Non-smoker Placebo | Placebo comparator | Non-smoker assigned to placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Cytokine Panel
Cytokines analyzed from plasma for IL-1beta, IL-6, IL-10, and TNF-alpha
Measured: baseline
Plasma Cytokine Panel
Plasma analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Measured: after 30 days of treatment
Plasma Cytokine Panel
Plasama analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Measured: after 60 days of treatment
Plasma Cytokine Panel on LPS treated whole blood
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Measured: baseline
Plasma Cytokine Panel on LPS treated whole blood
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Measured: after 30 days of treatment
Plasma Cytokine Panel on LPS treated whole blood
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Measured: after 60 days of treatment
Protein oxidation
Blood sample analyzed for protein oxidation
Measured: baseline
Protein oxidation
Blood sample analyzed for protein oxidation
Measured: after 30 days of treatment
Protein oxidation
Blood sample analyzed for protein oxidation
Measured: after 60 days of treatment
Lipid peroxidation
Blood sample analyzed for lipid peroxidation
Measured: baseline
Lipid peroxidation
Blood sample analyzed for lipid peroxidation
Measured: after 30 days of treatment
Lipid peroxidation
Blood sample analyzed for lipid peroxidation
Measured: after 60 days of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: baseline
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 1 week of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 2 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 3 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 4 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 5 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 6 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 7 weeks of treatment
Subjects' perceived mental health
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Measured: 8 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: baseline
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 1 week of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 2 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 3 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 4 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 5 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 6 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 7 weeks of treatment
Subject's perceived general health and well-being
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Measured: 8 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: baseline
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 1 week of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 2 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 3 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 4 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 5 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 6 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 7 weeks of treatment
Subject's perceived skin health
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Measured: 8 weeks of treatment
Quantitative Skin measures
A skin report will generated using the 3D Pear Plus system
Measured: baseline
Quantitative Skin measures
A skin report will generated using the 3D Pear Plus system
Measured: 30 days of treatment
Quantitative Skin measures
A skin report will generated using the 3D Pear Plus system
Measured: 60 days of treatment
Secondary outcomes (6)
Food Logs
Dietary intake will be reported for the 5 days prior to the study visit
Measured: baseline
Food Logs
Dietary intake will be reported for the 5 days prior to the study visit
Measured: 30 days of treatment
Food Logs
Dietary intake will be reported for the 5 days prior to the study visit
Measured: 60 days of treatment
Resting blood pressure
Blood pressure will be measured following a 10 minute rest
Measured: baseline
Resting blood pressure
Blood pressure will be measured following a 10 minute rest
Measured: 30 days of treatment
Resting blood pressure
Blood pressure will be measured following a 10 minute rest
Measured: 60 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start22 Oct 2021
- Primary completion27 Jun 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Deerland Probiotics and Enzymes
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162820
- Sponsor's protocol ID
- PRO-FY2021-416
- Status last verified
- Sep 2023
- First submitted
- 8 Dec 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Solarplast® on Immunity in Active Smokers and Non-smokers
- ClinicalTrials.gov ID
- NCT05162820
- Acronym / sponsor ID
- PRO-FY2021-416
- Conditions
- Immunity, Smoking, Cigarette
- Keywords
- Solarplast, Spinach, Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Deerland Probiotics and Enzymes
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. The hypothesis is that the Solarplast treatment will reduce oxidative stress biomarkers and favorably impact immune measures and both perceived and quantifiable measures of skin health, in both smokers and non-smokers, with a greater impact observed in smokers. Photographic analyses like the Pear Plus 3D system have been developed for clinical use for monitoring skin health.
Detailed description
Deerland Probiotics and Enzymes has developed a dietary supplement called Solarplast®, which is an organic spinach extract, currently being sold on the market (Solarplast - Deerland Probiotics and Enzymes). It contains a unique mixture of antioxidant enzymes and single antioxidant molecules that work to attack reactive oxygen species (ROS) through chaperone activity. These chaperones are naturally occurring proteins that provide protection from stress, such as ROS, heat, and infection, and can lead to reduced inflammation and alteration in immune function.
Spinach is rich in select vitamins and minerals, such as iron, vitamin A, riboflavin, and lutein-a carotenoid that acts as a natural antioxidant, protecting the body from toxins and ROS. Solarplast is thought to exhibit antioxidant protection against ROS, while also containing photosynthetic complexes with high concentrations of ATP, NADPH, ADP, AMP, NADP, niacin, B12, adenine, and ribose. Therefore, it may provide the components required to scavenge free radicals and mitigate ensuing damage from ROS.
In living cells, ROS such as singlet oxygen (·O), superoxide radical (O2· -), and hydroxyl radical (·OH) are continuously formed as a consequence of normal cellular metabolism and are increased under conditions of environmental stress. Production of ROS in quantities that overwhelm the endogenous antioxidant defense system leads to oxidative stress, and this oxidative stress is strongly linked to the pathogenesis of numerous diseases, including diabetes, cancer, and cardiovascular disease.
Oxidative stress leads to increases in proinflammatory cytokines such as IL-1B and TNF-alpha. Lipopolysaccharide (LPS) can induce ROS and proinflammatory cytokines. Antioxidants present in spinach may provide some protection against LPS actions.
It is well known that cigarette smoking exacerbates ROS formation and poses a significant pro-oxidant stress in vivo. In one puff of a cigarette, the smoker is exposed to >1015 free radicals in the gas phase alone, with additional exposure in the tar phase equal to >1017 free radicals·g-1. This direct exposure represents only a fraction of the total oxidative stress experienced, as cigarette smoke contributes to further endogenous ROS production mediated through inflammatory and immune processes. ROS formation due to cigarette smoking is thought to contribute to premature skin aging . Carotenoids like lutein in spinach, are believed to help protect skin from this ROS damage. Therefore, treating smokers with antioxidant therapy may not only alter immune function and measures of oxidative stress, but also prove helpful to both perceptions and measures of skin health.
Antioxidant supplementation can also reduce oxidative stress, which is linked to cognitive/mental health. Those who are exposed to high levels of oxidants and who are in a chronic state of oxidative stress (e.g., smokers) may be more susceptible to impaired mental health.
A previous clinical research trial evaluating Solarplast titled "Efficacy of Solarplast for Health and Oxidative Stress, A Randomized, Double-Blind, Placebo-Controlled Study" noted improved antioxidant defense and immunity, as well as improved subjective feelings of health (e.g., decreased irritability, decreased tension and anxiety), and improved self-reported skin health in a sample of smokers and non-smokers. The present study seeks to extend these findings in a larger sample of smokers.
The purpose of this study is to determine the impact of Solarplast treatment on measures of oxidative stress, immune function, skin appearance, and associated measures in 60 men and women, consisting of both cigarette smokers and nonsmokers. We hypothesize that the Solarplast treatment will reduce oxidative stress biomarkers and favorably impact immune measures and both perceived and quantifiable measures of skin health, in both smokers and non-smokers, with a greater impact observed in smokers. Smoking, causes a decrease in blood flow to skin and dryness along with other adverse effects that can prematurely age skin. As quantifiable measures provide more sound evidence than personal perceptions when evaluating skin treatments, there has been a greater push for more analytical methods in the assessment of skin regimens which include topographical, pigmentation, color, as well as other measures that will be employed in this study via photographical image analysis of subject's facial skin. Photographic analyses like the Pear Plus 3D system have been developed for clinical use for monitoring skin health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, Double-Blind, Placebo-Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Smoker Solarplast | Experimental | Dietary Supplement: 100 mg SolarplastSmoker's assigned to solarplast |
| Smoker Placebo | Placebo comparator | Dietary Supplement: PlaceboSmoker's assigned to placebo |
| Non-smoker Solarplast | Experimental | Dietary Supplement: 100 mg SolarplastNon-smoker assigned to solarplast |
| Non-smoker Placebo | Placebo comparator | Dietary Supplement: PlaceboNon-smoker assigned to placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- body mass index (BMI) between 18-40 kg/m2 (not morbidly obese)
- if a smoker, smokes at least 5 cigarettes per day for the past 12 months
- if a smoker, experience occasional mild skin irritations (e.g., rash, dryness, redness, itching, etc.)
- if non-smoker, not have used tobacco products or any smoked product (e.g., marijuana, cigar, pipe) in the past 12 months
- if non-smoker, not exposed to regular second-hand smoke (e.g., lives with or works in close proximity to a smoker)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100 mg Solarplast100 mg Solarplast delivered in capsules with the carrier of rice dextrin and medium chain triglycerides consumed daily at breakfast for 60 days | Dietary supplement | Non-smoker Solarplast, Smoker Solarplast |
| Placeborice dextrin and medium chain triglycerides in capsules consumed daily at breakfast for 60 days | Dietary supplement | Non-smoker Placebo, Smoker Placebo |
Primary outcome
Plasma Cytokine Panel
Time frame: baseline
Cytokines analyzed from plasma for IL-1beta, IL-6, IL-10, and TNF-alpha
Plasma Cytokine Panel
Time frame: after 30 days of treatment
Plasma analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Plasma Cytokine Panel
Time frame: after 60 days of treatment
Plasama analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Plasma Cytokine Panel on LPS treated whole blood
Time frame: baseline
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Plasma Cytokine Panel on LPS treated whole blood
Time frame: after 30 days of treatment
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Plasma Cytokine Panel on LPS treated whole blood
Time frame: after 60 days of treatment
LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha
Protein oxidation
Time frame: baseline
Blood sample analyzed for protein oxidation
Protein oxidation
Time frame: after 30 days of treatment
Blood sample analyzed for protein oxidation
Protein oxidation
Time frame: after 60 days of treatment
Blood sample analyzed for protein oxidation
Lipid peroxidation
Time frame: baseline
Blood sample analyzed for lipid peroxidation
Lipid peroxidation
Time frame: after 30 days of treatment
Blood sample analyzed for lipid peroxidation
Lipid peroxidation
Time frame: after 60 days of treatment
Blood sample analyzed for lipid peroxidation
Subjects' perceived mental health
Time frame: baseline
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 1 week of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 2 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 3 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 4 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 5 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 6 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 7 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subjects' perceived mental health
Time frame: 8 weeks of treatment
Subject's self-report different measures of mental health using a questionnaire with a scale of 1 (None of the time) to 5 (All of the time)
Subject's perceived general health and well-being
Time frame: baseline
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 1 week of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 2 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 3 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 4 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 5 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 6 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 7 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived general health and well-being
Time frame: 8 weeks of treatment
ubject's self-report different aspects of general health and well-being using a questionnaire with a scale of 1 (None) to 5 (Severe)
Subject's perceived skin health
Time frame: baseline
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 1 week of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 2 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 3 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 4 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 5 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 6 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 7 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Subject's perceived skin health
Time frame: 8 weeks of treatment
ubject's self-report their perception of their skin health for different skin qualities using a questionnaire with a scale of 1 (Very Bad) to 5 (Very Good)
Quantitative Skin measures
Time frame: baseline
A skin report will generated using the 3D Pear Plus system
Quantitative Skin measures
Time frame: 30 days of treatment
A skin report will generated using the 3D Pear Plus system
Quantitative Skin measures
Time frame: 60 days of treatment
A skin report will generated using the 3D Pear Plus system
6 secondary outcomes
Food Logs
Time frame: baseline
Food Logs
Time frame: 30 days of treatment
Food Logs
Time frame: 60 days of treatment
Resting blood pressure
Time frame: baseline
Resting blood pressure
Time frame: 30 days of treatment
Resting blood pressure
Time frame: 60 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100 mg Solarplast in people with Immunity and Smoking, Cigarette, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Cytokine Panel (time frame: baseline). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.