HealthyNCT06249620
Oral Supplementation With AM3, Hesperidin and Spermidine Supplementation on Immunity Response and Biological Age.
A study testing Inmunoferon in people with Healthy, run by Industrial Farmacéutica Cantabria, S.A. at 1 site in Spain.
Trial summary
The goal of this interventional study is to know the immune status of healthy participants and to obtain their biological age before and after two months of ingesting a dietary supplement. Read more about this study
- Who is it for?
- Ages 29 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inmunoferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 19 Apr 2022to 1 Oct 2022
- 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 29 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers who give their consent for the study will be included after having read and understood the information provided in the informed consent document
- Between 29-65 years old
- Residents in the Community of Madrid
Who cannot join
- Volunteers with no allergies or intolerances to the product
- Patologies
- Excessive alcohol consumption
- Pregnant women
- Antioxidants intake from supplements
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Biología Universidad Complutense de Madrid
Madrid, 28040
About this study
Official title: A Randomized Controlled Trial of Oral Suplementation With AM3, Hesperidin and Spermidine on Immunity Response and Biological Age in Healthy Volunteers.
The goal of this interventional study is to know the immune status of healthy participants and to obtain their biological age before and after two months of ingesting a dietary supplement. These individuals are compared with others who will be given a product of similar appearance, but without containing active components, being the constituents of the placebo group.
The study has a duration of 8 weeks, with 2 interventional visits (complete blood samples will be collected) at baseline and at 8 weeks.
In order to be included in the trial, the patient must read the Patient Information Sheet and sign the informed consent form.
The dosage regimen is two capsules per day in a single dose.
Read the detailed description
Forty consenting volunteers will be included in this prospective, randomized, double-blind study and will be randomized by a statistician independent of the research team.
The study consists of two milestones, in which different parameters are evaluated to finally reach the main goal, to measure their immune status and their biological age after taking the supplement (whose active ingredients include AM3, polyamines and flavonoids):
- Complete blood samples are collected from participants at milestone 1. To determine immune functions; neutrophils, lymphocytes and NK cells are measured. The adherence and chemotaxis capacity of neutrophils and lymphocytes is determined, as well as neutrophil phagocytosis and lymphocyte proliferation. In addition, the release of pro-inflammatory and anti-inflammatory cytokines is assessed.
In parallel, each participant will be given a survey to assess their perception of stress, which they will have to complete before and after 2 months of ingestion of the product (experimental and placebo).
- In milestone 2, oxidative and inflammatory stress parameters are analyzed. Regarding oxidative stress: catalase activity, glutathione reductase activity and reduced glutathione concentration are measured. In terms of inflammatory stress: concentrations of both proinflammatory and anti-inflammatory cytokines released are measured.
- Conditions
- Healthy
- Being tested
- Inmunoferon, Placebo
- Keywords
- AM3, Biological age, Inmunology clock, Spermidine, Hesperidin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InmunoferonDietary supplement
The dosage regimen is two capsules (with the active ingredients) per day in a single dose.The study lasted 8 weeks, with 2 interventional visits at baseline and at 8 weeks. Blood samples are collected twice: once on day 0 of the study and again at the final visit.
PlaceboDietary supplement
The dosage regimen is two capsules (with inert ingredients) per day in a single dose.The study lasted 8 weeks, with 2 interventional visits at baseline and at 8 weeks. Blood samples are collected twice: once on day 0 of the study and again at the final visit.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | The product (with the active ingredients) is randomly given to 20 participants for ingestion for two months.The dosage regimen is two capsules per day in a single dose. Receives: Dietary Supplement: Inmunoferon |
| Placebo | Placebo comparator | The other 20 participants will receive a similar looking product but with inert substances (placebo group).The dosage regimen is two capsules per day in a single dose. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biological Age
The Biological Age will be determined at baseline and week 8, by using the mathematical model 'Immunity Clock', based on the the natural killer activity, Lymphoproliferation and phagocytosis, and neutrophils and lymphocyts chemotaxis
Measured: Baseline and Week 8
Secondary outcomes (12)
Change in catalase activity with the use of a spectrophotometer
Measuring catalase activity with the use of a spectrophotometer will be used to assess oxidative stress at baseline and week 8 of treatment.
Measured: Baseline and week 8
Change in Glutathione peroxidase levels
To determine glutathione peroxidase levels at baseline and week 8 to asseess oxidative stress.
Measured: Baseline and week 8
Change in Glutathione reductase levels
To determine glutathione reductase levels at baseline and week 8 to assess oxidative stress.
Measured: Baseline and week 8
Change in reduced/oxized glutathione concentrations (GSH/GSSG)
To determine educed/oxized glutathione concentrations at baseline and week 8 to asseess oxidative stress.
Measured: Baseline and week 8
Change in inflammatory and anti-inflammatory cytokines levels
To determine levels of both inflammatory and anti-inflammatory cytokines at baseline and week 8 for evaluation of inflammatory stress.
Measured: Baseline and week 8
Change in Malondialdehyde concentrations
To determine concentration levels of malondialdehyde at baseline and at week 8 to evaluate peroxidative damage.
Measured: Baseline and week 8
Change in neutrophil levels
To determine neutrophil levels at baseline and week 8 to analyze the immunological functions.
Measured: Baseline and week 8
Change in lymphocyte levels
To determine lymphocite levels at baseline and week 8 to analyze the immunological functions.
Measured: Baseline and week 8
Change in cytotoxic activity of natural killer
The cytotoxic activity of NK cells was assessed by colorimetry of target cell lysis at baseline and week 8 of tretment to analyze the immunological functions.
Measured: Baseline and week 8
Change in chemotaxis index
To analyze the immunological functions, the chemotaxis index was calculated at baseline and week 8 to assess the migration capacity of neutrophils and lymphocytes .
Measured: Baseline and week 8
Change in lymphoproliferation levels
To analyze the immunological functions, lymphoproliferation capacity by neutrophils was measured at baseline and week 8.
Measured: Baseline and week 8
Change in phagocytosis activity
To analyze the immunological functions, phagocytosis activity by the neutrophils will also be determined at baseline and week 8 of treatment.
Phagocytosis is a critical biological activity through which the host can protect itself from infectious and non-infectious environmental particles and remove unwanted host cells in order to maintain tissue homeostasis.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Apr 2022
- Primary completion11 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249620
- Sponsor's protocol ID
- P21110b
- Status last verified
- Jan 2024
- First submitted
- 25 Jul 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wayne SJ, Rhyne RL, Garry PJ, Goodwin JS. Cell-mediated immunity as a predictor of morbidity and mortality in subjects over 60. J Gerontol. 1990 Mar;45(2):M45-8. doi: 10.1093/geronj/45.2.m45.
PubMed 2313042De la Fuente M, Miquel J. An update of the oxidation-inflammation theory of aging: the involvement of the immune system in oxi-inflamm-aging. Curr Pharm Des. 2009;15(26):3003-26. doi: 10.2174/138161209789058110.
PubMed 19754376Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, Pletcher MA, Smith AE, Tang K, Yuan CW, Brown JC, Friedman J, He J, Heuton KR, Holmberg M, Patel DJ, Reidy P, Carter A, Cercy K, Chapin A, Douwes-Schultz D, Frank T, Goettsch F, Liu PY, Nandakumar V, Reitsma MB, Reuter V, Sadat N, Sorensen RJD, Srinivasan V, Updike RL, York H, Lopez AD, Lozano R, Lim SS, Mokdad AH, Vollset SE, Murray CJL. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018 Nov 10;392(10159):2052-2090. doi: 10.1016/S0140-6736(18)31694-5. Epub 2018 Oct 16.
PubMed 30340847Medvedev ZA. An attempt at a rational classification of theories of ageing. Biol Rev Camb Philos Soc. 1990 Aug;65(3):375-98. doi: 10.1111/j.1469-185x.1990.tb01428.x. No abstract available.
PubMed 2205304HARMAN D. Aging: a theory based on free radical and radiation chemistry. J Gerontol. 1956 Jul;11(3):298-300. doi: 10.1093/geronj/11.3.298. No abstract available.
PubMed 13332224Martinez de Toda I, Mate I, Vida C, Cruces J, De la Fuente M. Immune function parameters as markers of biological age and predictors of longevity. Aging (Albany NY). 2016 Nov 28;8(11):3110-3119. doi: 10.18632/aging.101116.
PubMed 27899767Martinez de Toda I, Vida C, Diaz-Del Cerro E, De la Fuente M. The Immunity Clock. J Gerontol A Biol Sci Med Sci. 2021 Oct 13;76(11):1939-1945. doi: 10.1093/gerona/glab136.
PubMed 33979432Martinez de Toda I, Ceprian N, Diaz-Del Cerro E, De la Fuente M. The Role of Immune Cells in Oxi-Inflamm-Aging. Cells. 2021 Nov 1;10(11):2974. doi: 10.3390/cells10112974.
PubMed 34831197Arranz L, Fernandez C, Rodriguez A, Ribera JM, De la Fuente M. The glutathione precursor N-acetylcysteine improves immune function in postmenopausal women. Free Radic Biol Med. 2008 Nov 1;45(9):1252-62. doi: 10.1016/j.freeradbiomed.2008.07.014. Epub 2008 Jul 27.
PubMed 18694818Maggini S, Pierre A, Calder PC. Immune Function and Micronutrient Requirements Change over the Life Course. Nutrients. 2018 Oct 17;10(10):1531. doi: 10.3390/nu10101531.
PubMed 30336639Garrido A, Cruces J, Ceprian N, De la Fuente M. Improvements in Behavior and Immune Function and Increased Life Span of Old Mice Cohabiting With Adult Animals. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):873-881. doi: 10.1093/gerona/gly043.
PubMed 29506242Rojo JM, Rejas MT, Ojeda G, Portoles P, Barasoain I. Enhancement of lymphocyte proliferation, interleukin-2 production and NK activity by inmunoferon (AM-3), a fungal immunomodulator: variations in normal and immunosuppressed mice. Int J Immunopharmacol. 1986;8(6):593-7. doi: 10.1016/0192-0561(86)90031-7.
PubMed 3491798Moya P, Baixeras E, Barasoain I, Rojo JM, Ronda E, Alonso ML, Portoles A. Immunoferon (AM3) enhances the activities of early-type interferon inducers and natural killer cells. Immunopharmacol Immunotoxicol. 1987;9(2-3):243-56. doi: 10.3109/08923978709035213.
PubMed 2449486Sanchez Palacios A, Garcia Marrero JA, Schamann F. [Immunologic clinical evaluation of a biological response modifier, AM3, in the treatment of childhood infectious respiratory pathology]. Allergol Immunopathol (Madr). 1992 Jan-Feb;20(1):35-9. Spanish.
PubMed 1509986Villarrubia VG, Valladolid JM, Elorza FL, Sada G, Vilchez JG, Jimenez M, Herrerias JM. Therapeutic response of chronic active hepatitis B (CAHB) to a new immunomodulator: AM3. Immunohematological effects. Immunopharmacol Immunotoxicol. 1992;14(1-2):141-64. doi: 10.3109/08923979209009217.
PubMed 1597653
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Oral Suplementation With AM3, Hesperidin and Spermidine on Immunity Response and Biological Age in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT06249620
- Acronym / sponsor ID
- P21110b
- Conditions
- Healthy
- Keywords
- AM3, Biological age, Inmunology clock, Spermidine, Hesperidin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Industrial Farmacéutica Cantabria, S.A.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 8 Feb 2024 (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.
The goal of this interventional study is to know the immune status of healthy participants and to obtain their biological age before and after two months of ingesting a dietary supplement. These individuals are compared with others who will be given a product of similar appearance, but without containing active components, being the constituents of the placebo group.
The study has a duration of 8 weeks, with 2 interventional visits (complete blood samples will be collected) at baseline and at 8 weeks.
In order to be included in the trial, the patient must read the Patient Information Sheet and sign the informed consent form.
The dosage regimen is two capsules per day in a single dose.
Detailed description
Forty consenting volunteers will be included in this prospective, randomized, double-blind study and will be randomized by a statistician independent of the research team.
The study consists of two milestones, in which different parameters are evaluated to finally reach the main goal, to measure their immune status and their biological age after taking the supplement (whose active ingredients include AM3, polyamines and flavonoids):
- Complete blood samples are collected from participants at milestone 1. To determine immune functions; neutrophils, lymphocytes and NK cells are measured. The adherence and chemotaxis capacity of neutrophils and lymphocytes is determined, as well as neutrophil phagocytosis and lymphocyte proliferation. In addition, the release of pro-inflammatory and anti-inflammatory cytokines is assessed.
In parallel, each participant will be given a survey to assess their perception of stress, which they will have to complete before and after 2 months of ingestion of the product (experimental and placebo).
- In milestone 2, oxidative and inflammatory stress parameters are analyzed. Regarding oxidative stress: catalase activity, glutathione reductase activity and reduced glutathione concentration are measured. In terms of inflammatory stress: concentrations of both proinflammatory and anti-inflammatory cytokines released are measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Dietary Supplement: InmunoferonThe product (with the active ingredients) is randomly given to 20 participants for ingestion for two months.The dosage regimen is two capsules per day in a single dose. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe other 20 participants will receive a similar looking product but with inert substances (placebo group).The dosage regimen is two capsules per day in a single dose. |
Who may qualify
- Ages
- 29 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers who give their consent for the study will be included after having read and understood the information provided in the informed consent document
- Between 29-65 years old
- Residents in the Community of Madrid
Key exclusion criteria (5 listed)
- Volunteers with no allergies or intolerances to the product
- Patologies
- Excessive alcohol consumption
- Pregnant women
- Antioxidants intake from supplements
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 |
|---|---|---|
| InmunoferonThe dosage regimen is two capsules (with the active ingredients) per day in a single dose.The study lasted 8 weeks, with 2 interventional visits at baseline and at 8 weeks. Blood samples are collected twice: once on day 0 of the study and again at the final visit. | Dietary supplement | Active group |
| PlaceboThe dosage regimen is two capsules (with inert ingredients) per day in a single dose.The study lasted 8 weeks, with 2 interventional visits at baseline and at 8 weeks. Blood samples are collected twice: once on day 0 of the study and again at the final visit. | Dietary supplement | Placebo |
Primary outcome
Change in Biological Age
Time frame: Baseline and Week 8
The Biological Age will be determined at baseline and week 8, by using the mathematical model 'Immunity Clock', based on the the natural killer activity, Lymphoproliferation and phagocytosis, and neutrophils and lymphocyts chemotaxis
12 secondary outcomes
Change in catalase activity with the use of a spectrophotometer
Time frame: Baseline and week 8
Change in Glutathione peroxidase levels
Time frame: Baseline and week 8
Change in Glutathione reductase levels
Time frame: Baseline and week 8
Change in reduced/oxized glutathione concentrations (GSH/GSSG)
Time frame: Baseline and week 8
Change in inflammatory and anti-inflammatory cytokines levels
Time frame: Baseline and week 8
Change in Malondialdehyde concentrations
Time frame: Baseline and week 8
Change in neutrophil levels
Time frame: Baseline and week 8
Change in lymphocyte levels
Time frame: Baseline and week 8
Change in cytotoxic activity of natural killer
Time frame: Baseline and week 8
Change in chemotaxis index
Time frame: Baseline and week 8
Change in lymphoproliferation levels
Time frame: Baseline and week 8
Change in phagocytosis activity
Time frame: Baseline and week 8
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 8 Feb 2024.
- Results publication: PubMed 2313042Wayne SJ, Rhyne RL, Garry PJ, Goodwin JS. Cell-mediated immunity as a predictor of morbidity and mortality in subjects over 60. J Gerontol. 1990 Mar;45(2):M45-8. doi: 10.1093/geronj/45.2.m45.
- Results publication: PubMed 19754376De la Fuente M, Miquel J. An update of the oxidation-inflammation theory of aging: the involvement of the immune system in oxi-inflamm-aging. Curr Pharm Des. 2009;15(26):3003-26. doi: 10.2174/138161209789058110.
- Results publication: PubMed 30340847Foreman KJ, Marquez N, Dolgert A, Fukutaki K, Fullman N, McGaughey M, Pletcher MA, Smith AE, Tang K, Yuan CW, Brown JC, Friedman J, He J, Heuton KR, Holmberg M, Patel DJ, Reidy P, Carter A, Cercy K, Chapin A, Douwes-Schultz D, Frank T, Goettsch F, Liu PY, Nandakumar V, Reitsma MB, Reuter V, Sadat N, Sorensen RJD, Srinivasan V, Updike RL, York H, Lopez AD, Lozano R, Lim SS, Mokdad AH, Vollset SE, Murray CJL. Forecasting life expectancy, years of life lost, and all-cause and cause-specific mortality for 250 causes of death: reference and alternative scenarios for 2016-40 for 195 countries and territories. Lancet. 2018 Nov 10;392(10159):2052-2090. doi: 10.1016/S0140-6736(18)31694-5. Epub 2018 Oct 16.
- Results publication: PubMed 2205304Medvedev ZA. An attempt at a rational classification of theories of ageing. Biol Rev Camb Philos Soc. 1990 Aug;65(3):375-98. doi: 10.1111/j.1469-185x.1990.tb01428.x. No abstract available.
- Results publication: PubMed 13332224HARMAN D. Aging: a theory based on free radical and radiation chemistry. J Gerontol. 1956 Jul;11(3):298-300. doi: 10.1093/geronj/11.3.298. No abstract available.
- Results publication: PubMed 27899767Martinez de Toda I, Mate I, Vida C, Cruces J, De la Fuente M. Immune function parameters as markers of biological age and predictors of longevity. Aging (Albany NY). 2016 Nov 28;8(11):3110-3119. doi: 10.18632/aging.101116.
- Results publication: PubMed 33979432Martinez de Toda I, Vida C, Diaz-Del Cerro E, De la Fuente M. The Immunity Clock. J Gerontol A Biol Sci Med Sci. 2021 Oct 13;76(11):1939-1945. doi: 10.1093/gerona/glab136.
- Results publication: PubMed 34831197Martinez de Toda I, Ceprian N, Diaz-Del Cerro E, De la Fuente M. The Role of Immune Cells in Oxi-Inflamm-Aging. Cells. 2021 Nov 1;10(11):2974. doi: 10.3390/cells10112974.
- Results publication: PubMed 18694818Arranz L, Fernandez C, Rodriguez A, Ribera JM, De la Fuente M. The glutathione precursor N-acetylcysteine improves immune function in postmenopausal women. Free Radic Biol Med. 2008 Nov 1;45(9):1252-62. doi: 10.1016/j.freeradbiomed.2008.07.014. Epub 2008 Jul 27.
- Results publication: PubMed 30336639Maggini S, Pierre A, Calder PC. Immune Function and Micronutrient Requirements Change over the Life Course. Nutrients. 2018 Oct 17;10(10):1531. doi: 10.3390/nu10101531.
- Results publication: PubMed 29506242Garrido A, Cruces J, Ceprian N, De la Fuente M. Improvements in Behavior and Immune Function and Increased Life Span of Old Mice Cohabiting With Adult Animals. J Gerontol A Biol Sci Med Sci. 2018 Jun 14;73(7):873-881. doi: 10.1093/gerona/gly043.
- Results publication: PubMed 3491798Rojo JM, Rejas MT, Ojeda G, Portoles P, Barasoain I. Enhancement of lymphocyte proliferation, interleukin-2 production and NK activity by inmunoferon (AM-3), a fungal immunomodulator: variations in normal and immunosuppressed mice. Int J Immunopharmacol. 1986;8(6):593-7. doi: 10.1016/0192-0561(86)90031-7.
- Oxidation and Inflammation in the Immune and Nervous Systems, a Link Between Aging and AnxietyLink provided by the sponsor.
- Estrategias para enlentecer el envejecimiento en modelos de ratón y en humanos. Efectos sobre la longevidad y la edad biológicaLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inmunoferon in people with Healthy, run by Industrial Farmacéutica Cantabria, S.A. at 1 site in Spain.
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 3 inclusion and 5 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 8 Feb 2024. 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 Spain. 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 in Biological Age (time frame: Baseline and Week 8). 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 NCT06249620, which also lists 48 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 8 Feb 2024.