Everycell's Effect on DNA Damage, Inflammation, and Stress
Condition: Family Member
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Everycell™; Placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Everycell; DNA damage; DNA inflammation; DNA stress