NCT05162820

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

December 8, 2021

Last Update Submit

September 22, 2023

Conditions

ImmunitySmoking, Cigarette

Keywords

SolarplastSpinachSkin Health

Outcome Measures

Primary Outcomes (42)

  • Plasma Cytokine Panel

    Cytokines analyzed from plasma for IL-1beta, IL-6, IL-10, and TNF-alpha

    baseline

  • Plasma Cytokine Panel

    Plasma analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha

    after 30 days of treatment

  • Plasma Cytokine Panel

    Plasama analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha

    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

    baseline

  • Plasma Cytokine Panel on LPS treated whole blood

    LPS treated whole blood analyzed for IL-1beta, IL-6, IL-10, and TNF-alpha

    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

    after 60 days of treatment

  • Protein oxidation

    Blood sample analyzed for protein oxidation

    baseline

  • Protein oxidation

    Blood sample analyzed for protein oxidation

    after 30 days of treatment

  • Protein oxidation

    Blood sample analyzed for protein oxidation

    after 60 days of treatment

  • Lipid peroxidation

    Blood sample analyzed for lipid peroxidation

    baseline

  • Lipid peroxidation

    Blood sample analyzed for lipid peroxidation

    after 30 days of treatment

  • Lipid peroxidation

    Blood sample analyzed for lipid peroxidation

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    8 weeks of treatment

  • Quantitative Skin measures

    A skin report will generated using the 3D Pear Plus system

    baseline

  • Quantitative Skin measures

    A skin report will generated using the 3D Pear Plus system

    30 days of treatment

  • Quantitative Skin measures

    A skin report will generated using the 3D Pear Plus system

    60 days of treatment

Secondary Outcomes (6)

  • Food Logs

    baseline

  • Food Logs

    30 days of treatment

  • Food Logs

    60 days of treatment

  • Resting blood pressure

    baseline

  • Resting blood pressure

    30 days of treatment

  • +1 more secondary outcomes

Study Arms (4)

Smoker Solarplast

EXPERIMENTAL

Smoker's assigned to solarplast

Dietary Supplement: 100 mg Solarplast

Smoker Placebo

PLACEBO COMPARATOR

Smoker's assigned to placebo

Dietary Supplement: Placebo

Non-smoker Solarplast

EXPERIMENTAL

Non-smoker assigned to solarplast

Dietary Supplement: 100 mg Solarplast

Non-smoker Placebo

PLACEBO COMPARATOR

Non-smoker assigned to placebo

Dietary Supplement: Placebo

Interventions

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

Non-smoker SolarplastSmoker Solarplast
PlaceboDIETARY_SUPPLEMENT

rice dextrin and medium chain triglycerides in capsules consumed daily at breakfast for 60 days

Non-smoker PlaceboSmoker Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • Richard Bloomer, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Capsules will be of similar appearance and provided in un-identified bottles (A,B)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized, Double-Blind, Placebo-Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of the College of Health Sciences

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 17, 2021

Study Start

October 22, 2021

Primary Completion

June 27, 2023

Study Completion

August 24, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)