Family MemberNCT02032693
Everycell's Effect on DNA Damage, Inflammation, and Stress
A study testing Everycell™ in people with Family Member, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Member
- What is being tested?
- Everycell™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine, Clinical Research Building
Miami, Florida, 33136
About this study
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.
Read the 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.
- Conditions
- Family Member
- Being tested
- Everycell™, Placebo
- Keywords
- Everycell, DNA damage, DNA inflammation, DNA stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everycell™Dietary supplement
PlaceboOther
Also called Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| Everycell™ | Experimental | Patient will take 1 tablet two times daily of Everycell™ (double-blind) for the 4-week treatment period. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, 6-week follow-up
Secondary outcomes (20)
Change from Baseline in Systolic Blood Pressure at 4 weeks
Systolic and diastolic blood pressure measured.
Measured: Baseline, 4-week follow-up
Change from Baseline in Pulse at 4 weeks
Measured: Baseline, 4-week follow-up
Change from Baseline in Waist Circumference at 4 weeks
Measure of body composition: waist circumference (cm).
Measured: Baseline, 4-week follow-up
Change from Baseline in Hip Circumference at 4 weeks
Measure of body composition: hip circumference (cm).
Measured: Baseline, 4-week follow-up
Change from Baseline in Weight at 4 weeks
Measure of body composition: weight.
Measured: Baseline, 4-week follow-up
Change from Baseline in Height at 4 weeks
Measure of body composition: height.
Measured: Baseline, 4-week follow-up
Change from Baseline in Body Mass Index at 4 weeks
Measure of body composition: height and weight to assess BMI.
Measured: Baseline, 4-week follow-up
Change from Baseline in International Physical Activity Questionnaire at 4 weeks
Measured: Baseline, 4-week follow-up
Change from Baseline in SF-36v2™ Health Survey at 4 weeks
Measured: Baseline, 4-week follow-up
Change from Baseline in Systolic Blood Pressure at 6 weeks
Systolic and diastolic blood pressure measured.
Measured: Baseline, 6-week follow-up
Change from Baseline in Diastolic Blood Pressure at 4 weeks
Systolic and diastolic blood pressure measured.
Measured: Baseline, 4-week follow-up
Change from Baseline in Diastolic Blood Pressure at 6 weeks
Systolic and diastolic blood pressure measured.
Measured: Baseline, 6-week follow-up
Change from Baseline in Pulse at 6 weeks
Measured: Baseline, 6-week follow-up
Change from Baseline in Waist Circumference at 6 weeks
Measure of body composition: waist circumference (cm).
Measured: Baseline, 6-week follow-up
Change from Baseline in Hip Circumference at 6 weeks
Measure of body composition: hip circumference (cm).
Measured: Baseline, 6-week follow-up
Change from Baseline in Weight at 6 weeks
Measure of body composition: weight.
Measured: Baseline, 6-week follow-up
Change from Baseline in Height at 6 weeks
Measure of body composition: height.
Measured: Baseline, 6-week follow-up
Change from Baseline in Body Mass Index at 6 weeks
Measure of body composition: height and weight to assess BMI.
Measured: Baseline, 6-week follow-up
Change from Baseline in International Physical Activity Questionnaire at 6 weeks
Measured: Baseline, 6-week follow-up
Change from Baseline in SF-36v2™ Health Survey at 6 weeks
Measured: Baseline, 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family MemberStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- CellHealth Institute
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John Lewis, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032693
- Sponsor's protocol ID
- 20130411
- Status last verified
- May 2014
- First submitted
- 2 Jan 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02032693
- Acronym / sponsor ID
- 20130411
- Conditions
- Family Member
- Keywords
- Everycell, DNA damage, DNA inflammation, DNA stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- CellHealth Institute
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everycell™ | Experimental | Dietary Supplement: Everycell™Patient will take 1 tablet two times daily of Everycell™ (double-blind) for the 4-week treatment period. |
| Placebo | Placebo comparator | Other: PlaceboPatient will take 1 tablet two times daily of the placebo (double-blind) for the 4-week treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everycell™ | Dietary supplement | Everycell™ |
| PlaceboAlso: Sugar Pill | Other | Placebo |
Primary outcome
Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 4 weeks
Time frame: 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
Time frame: 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
Time frame: 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 Homocysteine at 4 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 4-week follow-up
Urine sample for 8-OHdG and 8-epi-PGF-2-alpha
Change from Baseline in Forkhead box protein 3 (Regulatory T-cell) at 4 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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-hydroxydeoxyguanosine at 6 weeks
Time frame: 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
Time frame: 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
Time frame: 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)
20 secondary outcomes
Change from Baseline in Systolic Blood Pressure at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Pulse at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Waist Circumference at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Hip Circumference at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Weight at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Height at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Body Mass Index at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in International Physical Activity Questionnaire at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in SF-36v2™ Health Survey at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Systolic Blood Pressure at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Diastolic Blood Pressure at 4 weeks
Time frame: Baseline, 4-week follow-up
Change from Baseline in Diastolic Blood Pressure at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Pulse at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Waist Circumference at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Hip Circumference at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Weight at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Height at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in Body Mass Index at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in International Physical Activity Questionnaire at 6 weeks
Time frame: Baseline, 6-week follow-up
Change from Baseline in SF-36v2™ Health Survey at 6 weeks
Time frame: Baseline, 6-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Lewis, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everycell™ in people with Family Member, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Nuclear factor kappa-light-chain-enhancer of activated B cells at 4 weeks (time frame: Baseline, 4-week follow-up). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.