The Effect of Dietary Supplementation on DNA Damage, Inflammation, Stress, and Related Factors Important in Somatic and Stem Cell Senescence in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline in Homocysteine at 4 weeks
研究概览
简要总结
The investigators are conducting this research because they want to determine if a dietary supplement, called Everycell™, has an effect on the functioning of the study participants' cells. The results of this research will be used to help develop additional strategies for trying to fight the effects of aging. The primary purpose of this study is to determine the effectiveness of Everycell™ compared to placebo (a pill that does nothing) on DNA damage, inflammation, stress, and related factors. Taking Everycell™ is not a medical prescription, treatment, or cure for any known disease or condition.
Helping patients' nutritional status is important to prevent the continued worsening of chronic diseases and also to counteract the effects of aging. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a dietary supplement may improve nutritional status and enable the body to normalize cellular functioning, which may improve quality of life. The results of this research will be used to determine if Everycell™ is beneficial for overall cellular health and to counteract the effects of aging.
详细描述
The proposed study is a 6-week, randomized, double-blind, placebo-controlled trial to evaluate the effect of everycell compared to placebo on DNA damage, inflammation, stress, and related factors in 30 healthy adults (18-55 years of age). Participants will be assessed at baseline, 4 weeks (end of intervention), and 6 weeks (2-week washout period), and the study will consist of two treatment arms, including: (a) Everycell and (b) placebo. Additionally, the study will examine subject health-related quality of life (QoL).
Specific Aim. Test the effect of Everycell compared to placebo on DNA damage, inflammation, stress, and related factors in a sample of healthy adults.
Hypothesis. The Everycell group will demonstrate improvements in DNA damage, inflammation, stress, and related factors at 4 and 6-week follow-ups compared to placebo.
Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the IRB.
No substantial psychological, medical, or social risks exist to the participants, other than minor discomfort associated with the venipuncture. The components of everycell should be harmless without significant food allergies. No serious, untoward side effects have been reported to the company by consumers nor observed during previous human studies. If any side effect does occur, the remedy is to discontinue until asymptomatic, and then reintroduce at 1/4 dosage, increasing by the same amount every 2 days, if uneventful, until full dosage is achieved. A toxicology search for each component reveals no unique toxicity characteristic of the materials. As reported by CellHealth Institute, the manufacturer of the product, many customers currently use Everycell, and CellHealth Institute is unaware of significant toxicities.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between the ages of 18 and 55
- •Live independently without medical assistance
- •Willing to provide informed consent to participate in the study
- •Willing to follow our procedures and requirements for the study, including:
- •providing blood, urine, and saliva samples
- •completing other assessments
- •Patients may take a similar dietary supplement as the one used in the study, but they must stop taking all similar dietary supplements 2 weeks prior to starting the study and for the 6 weeks duration of the study.
排除标准
- •Patients need to be free of major medical conditions, such as neurological, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint disorders or conditions; psychiatric diagnoses or psychotic disorders, and have no gastrointestinal disorders that could affect how the dietary supplement is absorbed by their body.
- •Cannot participate in another similar research trial within 30 days of participating in this study
- •Cannot be a smoker or have stopped smoking less than 6 months ago
- •Cannot currently be taking any chemotherapy or radiation treatment for cancer
- •Cannot be diagnosed with a terminal illness
- •Cannot be diagnosed with insulin-dependent diabetes and/or be taking metformin
- •Cannot be HIV positive
- •If female, the patient cannot currently be pregnant, breastfeeding, or intending to become pregnant within the next month
结局指标
主要结局
Change from Baseline in Homocysteine at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Telomere Length at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Cluster of Differentiation 4 (Regulatory T-cell) at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Cluster of Differentiation 8 at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Cluster of Differentiation 56 (Natural Killer cell) at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in 8-hydroxydeoxyguanosine at 4 weeks
时间窗: Baseline, 4-week follow-up
Urine sample for 8-OHdG and 8-epi-PGF-2-alpha
Change from Baseline in 8-epi-PGF-2-alpha at 4 weeks
时间窗: Baseline, 4-week follow-up
Urine sample for 8-OHdG and 8-epi-PGF-2-alpha
Change from Baseline in 8-hydroxydeoxyguanosine at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in 8-epi-PGF-2-alpha at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Fructosamine at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Protein Thiol Test at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 4 weeks
时间窗: Baseline, 4-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Telomere Length at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Fructosamine at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Protein Thiol Test at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Homocysteine at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Cluster of Differentiation 4 (Regulatory T-cell) at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Cluster of Differentiation 8 at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
Change from Baseline in Cluster of Differentiation 56 (Natural Killer cell) at 6 weeks
时间窗: Baseline, 6-week follow-up
Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)
次要结局
- Change from Baseline in Hip Circumference at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Systolic Blood Pressure at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Weight at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Height at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Body Mass Index at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in International Physical Activity Questionnaire at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in SF-36v2™ Health Survey at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Systolic Blood Pressure at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Diastolic Blood Pressure at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Diastolic Blood Pressure at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Pulse at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Waist Circumference at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Hip Circumference at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Weight at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Height at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Body Mass Index at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in International Physical Activity Questionnaire at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in SF-36v2™ Health Survey at 6 weeks(Baseline, 6-week follow-up)
- Change from Baseline in Pulse at 4 weeks(Baseline, 4-week follow-up)
- Change from Baseline in Waist Circumference at 4 weeks(Baseline, 4-week follow-up)
研究者
John E. Lewis
Associate Professor
University of Miami