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临床试验/NCT05162820
NCT05162820已完成不适用

Impact of Solarplast® on Immunity in Active Smokers and Non-smokers

University of Memphis2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Subjects' perceived mental health

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

盲法说明

Capsules will be of similar appearance and provided in un-identified bottles (A,B)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Smoker Placebo

Placebo Comparator

Smoker's assigned to placebo

干预措施: Placebo (Dietary Supplement)

Non-smoker Solarplast

Experimental

Non-smoker assigned to solarplast

干预措施: 100 mg Solarplast (Dietary Supplement)

Non-smoker Placebo

Placebo Comparator

Non-smoker assigned to placebo

干预措施: Placebo (Dietary Supplement)

Smoker Solarplast

Experimental

Smoker's assigned to solarplast

干预措施: 100 mg Solarplast (Dietary Supplement)

结局指标

主要结局

Subjects' perceived mental health

时间窗: 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

时间窗: 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

时间窗: 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)

Plasma Cytokine Panel on LPS treated whole blood

时间窗: after 60 days of treatment

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

Protein oxidation

时间窗: after 60 days of treatment

Blood sample analyzed for protein oxidation

Plasma Cytokine Panel

时间窗: after 60 days of treatment

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

Lipid peroxidation

时间窗: after 60 days of treatment

Blood sample analyzed for lipid peroxidation

Quantitative Skin measures

时间窗: 60 days of treatment

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

次要结局

  • Food Logs(60 days of treatment)
  • Resting blood pressure(60 days of treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Bloomer

Dean of the College of Health Sciences

University of Memphis

研究点 (2)

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