Everycell's Effect on DNA Damage, Inflammation, and Stress
Everycell's Effect on DNA Damage, Inflammation, and Stress
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.
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.

 CellHealth Institute applies the latest scientific methods to ensure the value and safety of
 their raw materials. CellHealth Institute products are manufactured in state-of-the-art
 facilities, under strict quality control and environmental protection standards.

 Participants will incur no additional appreciable psychological or social risks by
 participating in this study, although they may undergo psychological and physical discomfort
 sometimes. The process of interviewing during the assessment may cause discomfort. Discomfort
 or fatigue may also be experienced in completing the assessment battery.

 Alternatives to this study for improving DNA damage, inflammation, and stress include
 prescription medications, exercise, dietary modification, and other nutritional supplements.
 The risks of medications can be very significant, including life-threatening, but the risk of
 taking nutritional supplements is not totally understood, since they are not regulated by the
 US Food and Drug Administration. Medications and nutritional supplements, as part of a change
 in lifestyle behaviors, may also prove to be beneficial for DNA damage, inflammation, and
 stress, but their long-term use has unknown consequences.

 The information obtained in this study will help in determining the efficacy of using a
 nutritional supplement for improving DNA damage, inflammation, and stress outcomes. By
 participating in the study, subjects may experience improved DNA damage, inflammation, and
 stress. The risk of participating in this study is reasonable because of the potential
 enhancements in DNA damage, inflammation, and stress with improved nutritional status.
Inclusion Criteria:

 -  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:

 1. providing blood, urine, and saliva samples

 2. 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.

 Exclusion Criteria:

 -  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