AgingPhase 1/2RESET-YOUTHNCT03353597
Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects
A Phase 1/2 study testing Plasma Transfusion in people with Aging, run by Chandra Duggirala at 1 site in United States.
Trial summary
This trial is designed to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Plasma Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 15 Dec 2022
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 40.
- Stable medications for 2 months prior to Screening.
- Signed and dated written informed consent obtained from the subject in accordance with local Institutional Review Board regulations.
- Males and all Women of Child Bearing Potential agree to abstain from sex or use an adequate method of contraception for the duration of the study and for 30 days after the last dose of study drug. Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly), and , a woman who has been surgically sterilized or who has been in a state of amenorrhea.
Who cannot join
- Dementia of any etiology.
- Any medical condition other than dementia that could account for cognitive deficits (e.g., active seizure disorder, stroke, Central Nervous System diseases);
- History of significant cardiovascular, hematologic, renal, or advanced hepatic disease (or laboratory evidence thereof);
- History of major psychiatric illness or untreated depression;
- Neutrophil count <1,500/mm3, platelets <100,000/mm3, serum creatinine >1.5x upper limit of normal (ULN), total bilirubin >1.5 x ULN, Alanine Transaminase >3 x ULN, Aspartate Transaminase >3 x ULN, or International Normalized Ratio (INR) >1.2 at Screening evaluations;
- Evidence of any clinically significant findings on Screening or baseline evaluations which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of study data;
Show all 23Show fewer
- Current or recent history (within four weeks prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection;
- Current clinically significant viral infection;
- Major surgery within four weeks prior to Screening;
- Any contraindication to monthly plasma transfusions, including but not limited to:
- History of significant transfusion complications;
- Compatible plasma units not available;
- Prior intolerance to intravenous (IV) fluids;
- Immunoglobulin A deficiency by history or laboratory evidence at Screening;
- Bleeding;
- Any concurrent use of an anti-coagulant therapy.
- Daily administration of Aspirin 81mg will be allowed as long as the dose is stable for 30 days prior to Screening. Anti-platelet drugs are acceptable.
- Treatment with another investigational drug or participation in another interventional clinical trial within 3 months of Screening;
- Treatment with any human blood product, including IV immunoglobulin, during the 6 months prior to Screening or during the trial;
- Pregnant or lactating;
- Positive pregnancy test at Screening or Baseline (Day 1);
- Cancer within 5 years of Screening, except for nonmetastatic skin cancer or non-metastatic prostate cancer not expected to cause significant morbidity or mortality within one year of Baseline.
- AB blood type.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Infusion Center & Clinic
San Mateo, California, 94401
Janeen Bc, 650-348-6011
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About this study
This trial is designed to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of P16INK4a in peripheral blood T lymphocytes and skin biopsies.
Read the detailed description
Aging is a process for which there is no cure. Plasma transfusions, based on extensive animal studies, have the potential to reverse many, systemic age-related changes in the human body as well as age related chronic diseases. This is a non-randomized, uncontrolled phase I/II study to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of p16INK4a in peripheral blood T lymphocytes and skin biopsies. To determine the safety and tolerability of monthly, 2-unit transfusions of young (<25 years of age) healthy male donor plasma for 6 months in patients older then 40 years of age.
- Conditions
- Aging
- Being tested
- Plasma Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma TransfusionBiological
All subjects will receive monthly, 2-unit transfusions of young healthy male donor plasma for total of 6 treatments. The plasma will be administered at a transfusion services facility in a manner consistent with generally accepted and standard guidelines for plasma transfusions.
| Study group | Role | What they receive |
|---|---|---|
| Plasma Transfusion | Experimental | Plasma Transfusions with 2 units of plasma per dose, for a total of 6 doses Receives: Biological: Plasma Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological age as assessed by DNA methylation levels, to calculate the Epigenetic age.
The "epigenetic clock," as assessed by DNA methylation levels, which has been shown to be highly correlated with biologic age, longevity and is an independent predictor of mortality.
Measured: Baseline to end of Month 9.
Secondary outcomes (11)
Mental (Cognitive) Function
Executive functioning, as measured by the California Stroop test
Measured: Baseline and Month 9
Lung (Pulmonary) Function
FEV1 (Forced Expiratory Volume during the first second), and Peak Expiratory Flow
Measured: Baseline and Month 9
Kidney (Renal) Function
Twenty-four hour urine collections will be performed by patients at Baseline and at Month 9. Creatinine Clearance, a measure of Renal function will be determined by calculating the glomerular filtration rate (GFR), which is the sum of filtration rates in all functioning nephrons.
Measured: Baseline and Month 9
Muscle Strength
Unilateral Maximal Voluntary Isometric and Concentric Strength
Measured: Baseline and Month 9
Telomere Length
A telomere is a region of repetitive nucleotide sequences at each end of a chromosome, which protects the end of the chromosome from deterioration or from fusion with neighboring chromosomes.
Telomere shortening is associated with aging, mortality and aging-related diseases. Average telomere length will be measured in white blood cells by real time PCR technique.
Measured: Baseline and Month 9
Testosterone
Serum free and total Testosterone levels
Measured: Baseline and Month 9
Estrogen
Serum Estrogen levels
Measured: Baseline and Month 9
DHEAS
Dehydroepiandrosterone is an endogenous steroid hormone that has a role in the synthesis of sex steroids (androgens and estrogens), as well as neurotrophic and other effects
Measured: Baseline and Month 9
IGF-1
Insulin Like Growth Factor -1(IGF-1) declines continuously with aging in adults, and has been shown to mediate a number of pathways that are associated with longevity.
Measured: Baseline and Month 9
High Sensitivity C-Reactive Protein
C-Reactive Protein is a blood protein that is a marker of inflammation. Studies have suggested that a persistent level of inflammation plays a major role in cardiovascular and other degenerative and aging related diseases.
Measured: Baseline and Month 9
P16INK4a (A marker of cellular aging)
The cyclin- dependent kinase inhibitor CDKN2A, commonly referred to as p16INK4a or p16, has been established as a general marker of cellular senescence or aging. The expression of p16INK4a has been shown to increase exponentially with chronologic age. P16-INK4a is performed on a small specimen of blood drawn from the subjects, as well as from skin biopsy samples.
Measured: Baseline and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start15 May 2018 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chandra Duggirala
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Chandra Duggirala, Fountain Labs, Inc.
- Investigators
- Chandra s duggirala, Principal investigator, Fountain Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353597
- Sponsor's protocol ID
- FFP-1
- Acronym
- RESET-YOUTH
- Status last verified
- Jan 2018
- First submitted
- 7 Nov 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alcedo J, Kenyon C. Regulation of C. elegans longevity by specific gustatory and olfactory neurons. Neuron. 2004 Jan 8;41(1):45-55. doi: 10.1016/s0896-6273(03)00816-x.
PubMed 14715134Apfeld J, Kenyon C. Regulation of lifespan by sensory perception in Caenorhabditis elegans. Nature. 1999 Dec 16;402(6763):804-9. doi: 10.1038/45544.
PubMed 10617200Baht GS, Silkstone D, Vi L, Nadesan P, Amani Y, Whetstone H, Wei Q, Alman BA. Exposure to a youthful circulaton rejuvenates bone repair through modulation of beta-catenin. Nat Commun. 2015 May 19;6:7131. doi: 10.1038/ncomms8131.
PubMed 25988592Baker DJ, Wijshake T, Tchkonia T, LeBrasseur NK, Childs BG, van de Sluis B, Kirkland JL, van Deursen JM. Clearance of p16Ink4a-positive senescent cells delays ageing-associated disorders. Nature. 2011 Nov 2;479(7372):232-6. doi: 10.1038/nature10600.
PubMed 22048312Baylin SB, Jones PA. A decade of exploring the cancer epigenome - biological and translational implications. Nat Rev Cancer. 2011 Sep 23;11(10):726-34. doi: 10.1038/nrc3130.
PubMed 21941284Bell JT, Tsai PC, Yang TP, Pidsley R, Nisbet J, Glass D, Mangino M, Zhai G, Zhang F, Valdes A, Shin SY, Dempster EL, Murray RM, Grundberg E, Hedman AK, Nica A, Small KS; MuTHER Consortium; Dermitzakis ET, McCarthy MI, Mill J, Spector TD, Deloukas P. Epigenome-wide scans identify differentially methylated regions for age and age-related phenotypes in a healthy ageing population. PLoS Genet. 2012;8(4):e1002629. doi: 10.1371/journal.pgen.1002629. Epub 2012 Apr 19.
PubMed 22532803Benayoun BA, Pollina EA, Brunet A. Epigenetic regulation of ageing: linking environmental inputs to genomic stability. Nat Rev Mol Cell Biol. 2015 Oct;16(10):593-610. doi: 10.1038/nrm4048. Epub 2015 Sep 16.
PubMed 26373265Bergman RJ, Gazit D, Kahn AJ, Gruber H, McDougall S, Hahn TJ. Age-related changes in osteogenic stem cells in mice. J Bone Miner Res. 1996 May;11(5):568-77. doi: 10.1002/jbmr.5650110504.
PubMed 9157771BLUEPRINT consortium. Quantitative comparison of DNA methylation assays for biomarker development and clinical applications. Nat Biotechnol. 2016 Jul;34(7):726-37. doi: 10.1038/nbt.3605. Epub 2016 Jun 27.
PubMed 27347756Bocklandt S, Lin W, Sehl ME, Sanchez FJ, Sinsheimer JS, Horvath S, Vilain E. Epigenetic predictor of age. PLoS One. 2011;6(6):e14821. doi: 10.1371/journal.pone.0014821. Epub 2011 Jun 22.
PubMed 21731603Bollati V, Schwartz J, Wright R, Litonjua A, Tarantini L, Suh H, Sparrow D, Vokonas P, Baccarelli A. Decline in genomic DNA methylation through aging in a cohort of elderly subjects. Mech Ageing Dev. 2009 Apr;130(4):234-9. doi: 10.1016/j.mad.2008.12.003. Epub 2008 Dec 27.
PubMed 19150625Brack AS, Conboy MJ, Roy S, Lee M, Kuo CJ, Keller C, Rando TA. Increased Wnt signaling during aging alters muscle stem cell fate and increases fibrosis. Science. 2007 Aug 10;317(5839):807-10. doi: 10.1126/science.1144090.
PubMed 17690295Brandli O, Schindler C, Kunzli N, Keller R, Perruchoud AP. Lung function in healthy never smoking adults: reference values and lower limits of normal of a Swiss population. Thorax. 1996 Mar;51(3):277-83. doi: 10.1136/thx.51.3.277.
PubMed 8779131Burch JB, Augustine AD, Frieden LA, Hadley E, Howcroft TK, Johnson R, Khalsa PS, Kohanski RA, Li XL, Macchiarini F, Niederehe G, Oh YS, Pawlyk AC, Rodriguez H, Rowland JH, Shen GL, Sierra F, Wise BC. Advances in geroscience: impact on healthspan and chronic disease. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1(Suppl 1):S1-3. doi: 10.1093/gerona/glu041.
PubMed 24833579Burrows B, Lebowitz MD, Camilli AE, Knudson RJ. Longitudinal changes in forced expiratory volume in one second in adults. Methodologic considerations and findings in healthy nonsmokers. Am Rev Respir Dis. 1986 Jun;133(6):974-80. doi: 10.1164/arrd.1986.133.6.974.
PubMed 3717769
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects
- ClinicalTrials.gov ID
- NCT03353597
- Acronym / sponsor ID
- RESET-YOUTH / FFP-1
- Conditions
- Aging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,120 participants (estimated)
- Lead sponsor
- Chandra DuggiralaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 27 Nov 2017 (actual)
- 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.
This trial is designed to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of P16INK4a in peripheral blood T lymphocytes and skin biopsies.
Detailed description
Aging is a process for which there is no cure. Plasma transfusions, based on extensive animal studies, have the potential to reverse many, systemic age-related changes in the human body as well as age related chronic diseases. This is a non-randomized, uncontrolled phase I/II study to study the effects of monthly transfusions of young healthy male donor plasma on biological age as assessed by DNA methylation levels, and changes in cognitive, renal, and pulmonary function, muscle strength, telomere length, testosterone, estrogen, DHEAS, IGF-1, high resolution C-Reactive protein, and expression of p16INK4a in peripheral blood T lymphocytes and skin biopsies. To determine the safety and tolerability of monthly, 2-unit transfusions of young (<25 years of age) healthy male donor plasma for 6 months in patients older then 40 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma Transfusion | Experimental | Biological: Plasma TransfusionPlasma Transfusions with 2 units of plasma per dose, for a total of 6 doses |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 40.
- Stable medications for 2 months prior to Screening.
- Signed and dated written informed consent obtained from the subject in accordance with local Institutional Review Board regulations.
- Males and all Women of Child Bearing Potential agree to abstain from sex or use an adequate method of contraception for the duration of the study and for 30 days after the last dose of study drug. Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly), and , a woman who has been surgically sterilized or who has been in a state of amenorrhea.
Key exclusion criteria (23 listed)
- Dementia of any etiology.
- Any medical condition other than dementia that could account for cognitive deficits (e.g., active seizure disorder, stroke, Central Nervous System diseases);
- History of significant cardiovascular, hematologic, renal, or advanced hepatic disease (or laboratory evidence thereof);
- History of major psychiatric illness or untreated depression;
- Neutrophil count <1,500/mm3, platelets <100,000/mm3, serum creatinine >1.5x upper limit of normal (ULN), total bilirubin >1.5 x ULN, Alanine Transaminase >3 x ULN, Aspartate Transaminase >3 x ULN, or International Normalized Ratio (INR) >1.2 at Screening evaluations;
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 |
|---|---|---|
| Plasma TransfusionAll subjects will receive monthly, 2-unit transfusions of young healthy male donor plasma for total of 6 treatments. The plasma will be administered at a transfusion services facility in a manner consistent with generally accepted and standard guidelines for plasma transfusions. | Biological | Plasma Transfusion |
Primary outcome
Biological age as assessed by DNA methylation levels, to calculate the Epigenetic age.
Time frame: Baseline to end of Month 9.
The "epigenetic clock," as assessed by DNA methylation levels, which has been shown to be highly correlated with biologic age, longevity and is an independent predictor of mortality.
11 secondary outcomes
Mental (Cognitive) Function
Time frame: Baseline and Month 9
Lung (Pulmonary) Function
Time frame: Baseline and Month 9
Kidney (Renal) Function
Time frame: Baseline and Month 9
Muscle Strength
Time frame: Baseline and Month 9
Telomere Length
Time frame: Baseline and Month 9
Testosterone
Time frame: Baseline and Month 9
Estrogen
Time frame: Baseline and Month 9
DHEAS
Time frame: Baseline and Month 9
IGF-1
Time frame: Baseline and Month 9
High Sensitivity C-Reactive Protein
Time frame: Baseline and Month 9
P16INK4a (A marker of cellular aging)
Time frame: Baseline and Month 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 14715134Alcedo J, Kenyon C. Regulation of C. elegans longevity by specific gustatory and olfactory neurons. Neuron. 2004 Jan 8;41(1):45-55. doi: 10.1016/s0896-6273(03)00816-x.
- Background: PubMed 10617200Apfeld J, Kenyon C. Regulation of lifespan by sensory perception in Caenorhabditis elegans. Nature. 1999 Dec 16;402(6763):804-9. doi: 10.1038/45544.
- Background: PubMed 25988592Baht GS, Silkstone D, Vi L, Nadesan P, Amani Y, Whetstone H, Wei Q, Alman BA. Exposure to a youthful circulaton rejuvenates bone repair through modulation of beta-catenin. Nat Commun. 2015 May 19;6:7131. doi: 10.1038/ncomms8131.
- Background: PubMed 22048312Baker DJ, Wijshake T, Tchkonia T, LeBrasseur NK, Childs BG, van de Sluis B, Kirkland JL, van Deursen JM. Clearance of p16Ink4a-positive senescent cells delays ageing-associated disorders. Nature. 2011 Nov 2;479(7372):232-6. doi: 10.1038/nature10600.
- Background: PubMed 21941284Baylin SB, Jones PA. A decade of exploring the cancer epigenome - biological and translational implications. Nat Rev Cancer. 2011 Sep 23;11(10):726-34. doi: 10.1038/nrc3130.
- Background: PubMed 22532803Bell JT, Tsai PC, Yang TP, Pidsley R, Nisbet J, Glass D, Mangino M, Zhai G, Zhang F, Valdes A, Shin SY, Dempster EL, Murray RM, Grundberg E, Hedman AK, Nica A, Small KS; MuTHER Consortium; Dermitzakis ET, McCarthy MI, Mill J, Spector TD, Deloukas P. Epigenome-wide scans identify differentially methylated regions for age and age-related phenotypes in a healthy ageing population. PLoS Genet. 2012;8(4):e1002629. doi: 10.1371/journal.pgen.1002629. Epub 2012 Apr 19.
- Background: PubMed 26373265Benayoun BA, Pollina EA, Brunet A. Epigenetic regulation of ageing: linking environmental inputs to genomic stability. Nat Rev Mol Cell Biol. 2015 Oct;16(10):593-610. doi: 10.1038/nrm4048. Epub 2015 Sep 16.
- Background: PubMed 9157771Bergman RJ, Gazit D, Kahn AJ, Gruber H, McDougall S, Hahn TJ. Age-related changes in osteogenic stem cells in mice. J Bone Miner Res. 1996 May;11(5):568-77. doi: 10.1002/jbmr.5650110504.
- Background: PubMed 27347756BLUEPRINT consortium. Quantitative comparison of DNA methylation assays for biomarker development and clinical applications. Nat Biotechnol. 2016 Jul;34(7):726-37. doi: 10.1038/nbt.3605. Epub 2016 Jun 27.
- Background: PubMed 21731603Bocklandt S, Lin W, Sehl ME, Sanchez FJ, Sinsheimer JS, Horvath S, Vilain E. Epigenetic predictor of age. PLoS One. 2011;6(6):e14821. doi: 10.1371/journal.pone.0014821. Epub 2011 Jun 22.
- Background: PubMed 19150625Bollati V, Schwartz J, Wright R, Litonjua A, Tarantini L, Suh H, Sparrow D, Vokonas P, Baccarelli A. Decline in genomic DNA methylation through aging in a cohort of elderly subjects. Mech Ageing Dev. 2009 Apr;130(4):234-9. doi: 10.1016/j.mad.2008.12.003. Epub 2008 Dec 27.
- Background: PubMed 17690295Brack AS, Conboy MJ, Roy S, Lee M, Kuo CJ, Keller C, Rando TA. Increased Wnt signaling during aging alters muscle stem cell fate and increases fibrosis. Science. 2007 Aug 10;317(5839):807-10. doi: 10.1126/science.1144090.
- Individual participant dataSharing planned: No
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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.
Chandra s duggirala principal investigator
Fountain Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Plasma Transfusion in people with Aging, run by Chandra Duggirala 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 4 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chandra s Duggirala, MBBS, MD (815-793-1273, cduggi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological age as assessed by DNA methylation levels, to calculate the Epigenetic age. (time frame: Baseline to end of Month 9.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353597, which also lists 58 linked publications.
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 17 Jan 2018.