Family Member Clinical Trial
Official title:
The Effect of Dietary Supplementation on DNA Damage, Inflammation, Stress, and Related Factors Important in Somatic and Stem Cell Senescence in Healthy Adults
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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