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

NCT02032693 | Completed

• 1 other identifier: 20130411
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Family Member

Keywords

Everycell; DNA damage; DNA inflammation; DNA stress

Outcome Measures

Primary Outcomes (22)

• Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Fructosamine at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Protein Thiol Test at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Homocysteine at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Telomere Length at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Cluster of Differentiation 4 (Regulatory T-cell) at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Cluster of Differentiation 8 at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Cluster of Differentiation 56 (Natural Killer cell) at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in 8-hydroxydeoxyguanosine at 4 weeks

  Urine sample for 8-OHdG and 8-epi-PGF-2-alpha

  Baseline, 4-week follow-up

• Change from Baseline in 8-epi-PGF-2-alpha at 4 weeks

  Urine sample for 8-OHdG and 8-epi-PGF-2-alpha

  Baseline, 4-week follow-up

• Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 4 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 4-week follow-up

• Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Fructosamine at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Protein Thiol Test at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Homocysteine at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Telomere Length at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Cluster of Differentiation 4 (Regulatory T-cell) at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Cluster of Differentiation 8 at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Cluster of Differentiation 56 (Natural Killer cell) at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in 8-hydroxydeoxyguanosine at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in 8-epi-PGF-2-alpha at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

• Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 6 weeks

  Blood draw for NF-kB, fructosamine, protein thiol test, homocysteine, telomere length, and CD4/FoxP3 (regulatory T-cells), CD8, and CD56 (NK cell)

  Baseline, 6-week follow-up

Secondary Outcomes (20)

• Change from Baseline in Systolic Blood Pressure at 4 weeks

  Baseline, 4-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

• Change from Baseline in Hip Circumference at 4 weeks

  Baseline, 4-week follow-up

• Change from Baseline in Weight at 4 weeks

  Baseline, 4-week follow-up

Study Arms (2)

Everycell™

EXPERIMENTAL

Patient will take 1 tablet two times daily of Everycell™ (double-blind) for the 4-week treatment period.

Dietary Supplement: Everycell™

Placebo

PLACEBO COMPARATOR

Patient will take 1 tablet two times daily of the placebo (double-blind) for the 4-week treatment period.

Other: Placebo

Interventions

Everycell™ DIETARY_SUPPLEMENT

Everycell™

Placebo OTHER

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• CellHealth Institute: collaborator

Study Sites (1)

University of Miami Miller School of Medicine, Clinical Research Building

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• John Lewis, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 10, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

US (1)