Healthy AgingSTAMINANCT06145087
Effects of a Supplement to Target Ageing Mechanisms on Vascular Function (STAMINA)
A study testing "NOVOS Core" supplement in people with Healthy Aging and Vascular Dilation, run by University of Surrey at 1 site in United Kingdom.
Trial summary
In the ageing society, extending the healthy lifespan is a major challenge and a healthy diet may play an import role in maintaining health throughout life. With increasing age cardiovascular function declines and large and small blood vessels change in various and complex ways and these changes may lead to many… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Vascular Dilation
- What is being tested?
- "NOVOS Core" supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 19 Dec 2025
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy. (Note: those with stable conditions that do not interfere with the study objectives/procedures will be included at the PI discretion).
- >40 years
- Body mass index >20 kg/m2
- Systolic blood pressure >=120 mmHg
- Smartphone with step counter
Who cannot join
- Symptoms of acute infection
- Cardiac arrhythmias
- Active malignancy
- Clinical signs or symptoms of unstable cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease). These include angina pectoris, dyspnoea, palpitation, syncope, claudication, active vasoactive medication.
- Women who have been pregnant in the last three months, currently pregnant, preparing to become pregnant during the study, or breastfeeding.
- Those that have undergone a change in hormone-based therapies such as, but not limited to, oral contraceptive pills or progesterone pills within the last 2 months. Progesterone releasing devices are considered hormone-based therapy. Spironolactone is not considered a hormone-based therapy.
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- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects who have a history of or a current psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study in the opinion of the principal investigator.
- Subjects with or who have recently experienced traumatic injury, infections, or major surgery at the discretion of the qualified investigator.
- Subjects who are likely to start taking drugs/medication on a continuous basis or that will undergo surgery during the trial.
- Subjects engaged in donation or who were recipients of blood products within 90 days before the start of the study.
- Subjects with alcohol use of more than 2 alcoholic beverages per day within the past month.
- Subjects participated in a clinical trial with a medicinal, supplemental, nutraceutical or drug within the past two months prior to the first dose in the current study.
- If participants take fish oil supplements, they will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
- Subjects using anti-inflammatory drugs on a chronic basis (e.g. aspirin, ibuprofen, diclofenac, celecoxib, etc).
- Subjects using supplements or substances present in formulation (malate, fisetin, glucosamine, alpha ketoglutaric acid, glycine, theanine, Rhodiola rosea, hyaluronic acid, ginger extract, pterostilbene, lithium). Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
- Subjects using supplements or substances similar as those used in the formulation (e.g. resveratrol (similar to pterostilbene) or quercetin (similar to fisetin). Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial.
- Subjects taking high-dose niacin (nicotinic acid), high-dose vitamin B3, high-dose nicotinamide (niacinamide) within 21 days before the start of the trial. Participants will be asked to stop taking these supplements 21 days before the start of trial and during the trial. .
- Subjects with clinically significant abnormal laboratory results at screening. Known allergy/intolerance to any of the components in the supplement product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Short and Intermediate Term Effects of a Supplement Mix Designed to Target Ageing Mechanisms on Vascular Function in Healthy Middle-aged Participants (STAMINA Study)
In the ageing society, extending the healthy lifespan is a major challenge and a healthy diet may play an import role in maintaining health throughout life. With increasing age cardiovascular function declines and large and small blood vessels change in various and complex ways and these changes may lead to many age-related diseases. On a molecular level, there are many mechanisms that are associated with ageing including cellular senescence, loss of proteostasis, altered cellular communication, genomic instability, epigenetic alterations, telomere shortening, deregulated nutrient sensing, stem cell exhaustion and protein crosslinking. Animal and human studies suggest that dietary supplements may be able to affect these mechanisms. What the effect of the NOVOS Core supplement is on cardiovascular functions is not known.
The aim of the present study is to investigate the short and intermediate term effects of a supplement mix designed to target ageing mechanism on vascular function in healthy middle-aged subjects. (STAMINA Study) The hypothesis is that the supplement will lead to acute and sustained changes in biomarkers of vascular function and health.
60 healthy middle-aged people will be recruited and randomly assigned to either daily intake of the NOVOS Core supplement (n=30) or placebo (n=30) for up to 6 months (3-6). The supplement (NOVOS Core) is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. The study will require 2 visits by participants during which non-invasive vascular exams will be performed, venous blood taken and spot urine sample collected. The primary endpoint is change in flow-mediated dilation, secondary endpoints are change in blood pressure, cholesterol, arterial stiffness, microvascular function cardiovascular risk SCORE and daily walking distance. Tertiary endpoints are changes in biomarkers of ageing as assessed in blood samples. Measurements will be taken on the first day before and 2 hours after ingestion of the first supplement or placebo. Participants will consume the supplement or placebo for 6 months and vascular exams and one blood draw will be repeated during the final visit.
- Conditions
- Healthy Aging, Vascular Dilation
- Being tested
- "NOVOS Core" supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"NOVOS Core" supplementDietary supplement
The supplement mix (15 g) is supplied as a powder to be mixed in water or other beverages like tea or coffee once per day.
PlaceboDietary supplement
The placebo mix (15 g) is supplied as a powder to be mixed in water or other beverages like tea or coffee.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. Receives: Dietary Supplement: Placebo |
| "NOVOS Core" supplement | Experimental | The "NOVOS Core" supplement is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. Receives: Dietary Supplement: "NOVOS Core" supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in flow-mediated dilation
Change in flow-mediated dilation with ultrasound (%)
Measured: 6 months
Secondary outcomes (9)
Change in systolic blood pressure
Change in systolic blood pressure (mmHg)
Measured: 6 months
Change in diastolic blood pressure
Change in diastolic blood pressure (mmHg)
Measured: 6 months
Change in cholesterol
Change in cholesterol including LDL, HDL, total cholesterol
Measured: 6 months
Change in total cholesterol
Change in total cholesterol (mml/l)
Measured: 6 months
Change in LDL cholesterol
Change in LDL cholesterol (mmol/l)
Measured: 6 months
Change in HDL cholesterol
Change in HDL cholesterol (mmol/l)
Measured: 6 months
Change in arterial stiffness
Change in pulse wave velocity (m/s)
Measured: 6 months
Change in daily walking distance
Change in daily walking distance in kilometers as measure by personal smartphone
Measured: 6 months
Change in cardiovascular risk
Change in calculated 10 year cardiovascular risk (European Society of Cardiology Systematic Coronary Risk Evaluation [ESC SCORE])
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jun 2023
- Primary completion5 Aug 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-armed parallel group, randomised, controlled, double-blind clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Christian Heiss, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145087
- Sponsor's protocol ID
- STAMINA_Protocol_V4.0
- Acronym
- STAMINA
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piercy C, Harris J, Sackho K, Campagnolo P, Barardo D, Creagh-Brown B, Heiss C. Acute and 6-month vascular effects of a multi-component nutritional supplement: a randomized controlled trial. Eur Heart J Open. 2026 Nov 4;6(6):oeag157. doi: 10.1093/ehjopen/oeag157. eCollection 2026 Nov.
PubMed 42979377
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Short and Intermediate Term Effects of a Supplement Mix Designed to Target Ageing Mechanisms on Vascular Function in Healthy Middle-aged Participants (STAMINA Study)
- ClinicalTrials.gov ID
- NCT06145087
- Acronym / sponsor ID
- STAMINA / STAMINA_Protocol_V4.0
- Conditions
- Healthy Aging, Vascular Dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 22 Nov 2023 (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.
In the ageing society, extending the healthy lifespan is a major challenge and a healthy diet may play an import role in maintaining health throughout life. With increasing age cardiovascular function declines and large and small blood vessels change in various and complex ways and these changes may lead to many age-related diseases. On a molecular level, there are many mechanisms that are associated with ageing including cellular senescence, loss of proteostasis, altered cellular communication, genomic instability, epigenetic alterations, telomere shortening, deregulated nutrient sensing, stem cell exhaustion and protein crosslinking. Animal and human studies suggest that dietary supplements may be able to affect these mechanisms. What the effect of the NOVOS Core supplement is on cardiovascular functions is not known.
The aim of the present study is to investigate the short and intermediate term effects of a supplement mix designed to target ageing mechanism on vascular function in healthy middle-aged subjects. (STAMINA Study) The hypothesis is that the supplement will lead to acute and sustained changes in biomarkers of vascular function and health.
60 healthy middle-aged people will be recruited and randomly assigned to either daily intake of the NOVOS Core supplement (n=30) or placebo (n=30) for up to 6 months (3-6). The supplement (NOVOS Core) is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. The study will require 2 visits by participants during which non-invasive vascular exams will be performed, venous blood taken and spot urine sample collected. The primary endpoint is change in flow-mediated dilation, secondary endpoints are change in blood pressure, cholesterol, arterial stiffness, microvascular function cardiovascular risk SCORE and daily walking distance. Tertiary endpoints are changes in biomarkers of ageing as assessed in blood samples. Measurements will be taken on the first day before and 2 hours after ingestion of the first supplement or placebo. Participants will consume the supplement or placebo for 6 months and vascular exams and one blood draw will be repeated during the final visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two-armed parallel group, randomised, controlled, double-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. |
| "NOVOS Core" supplement | Experimental | Dietary Supplement: "NOVOS Core" supplementThe "NOVOS Core" supplement is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generally healthy. (Note: those with stable conditions that do not interfere with the study objectives/procedures will be included at the PI discretion).
- >40 years
- Body mass index >20 kg/m2
- Systolic blood pressure >=120 mmHg
- Smartphone with step counter
Key exclusion criteria (19 listed)
- Symptoms of acute infection
- Cardiac arrhythmias
- Active malignancy
- Clinical signs or symptoms of unstable cardiovascular disease (coronary artery disease, lower extremity artery disease, cerebrovascular disease). These include angina pectoris, dyspnoea, palpitation, syncope, claudication, active vasoactive medication.
- Women who have been pregnant in the last three months, currently pregnant, preparing to become pregnant during the study, or breastfeeding.
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 |
|---|---|---|
| "NOVOS Core" supplementThe supplement mix (15 g) is supplied as a powder to be mixed in water or other beverages like tea or coffee once per day. | Dietary supplement | "NOVOS Core" supplement |
| PlaceboThe placebo mix (15 g) is supplied as a powder to be mixed in water or other beverages like tea or coffee. | Dietary supplement | Placebo |
Primary outcome
Change in flow-mediated dilation
Time frame: 6 months
Change in flow-mediated dilation with ultrasound (%)
9 secondary outcomes
Change in systolic blood pressure
Time frame: 6 months
Change in diastolic blood pressure
Time frame: 6 months
Change in cholesterol
Time frame: 6 months
Change in total cholesterol
Time frame: 6 months
Change in LDL cholesterol
Time frame: 6 months
Change in HDL cholesterol
Time frame: 6 months
Change in arterial stiffness
Time frame: 6 months
Change in daily walking distance
Time frame: 6 months
Change in cardiovascular risk
Time frame: 6 months
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 22 Jan 2026.
- Derived from this study: PubMed 42979377Piercy C, Harris J, Sackho K, Campagnolo P, Barardo D, Creagh-Brown B, Heiss C. Acute and 6-month vascular effects of a multi-component nutritional supplement: a randomized controlled trial. Eur Heart J Open. 2026 Nov 4;6(6):oeag157. doi: 10.1093/ehjopen/oeag157. eCollection 2026 Nov.
- Individual participant dataSharing planned: Undecided
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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 "NOVOS Core" supplement in people with Healthy Aging and Vascular Dilation, run by University of Surrey at 1 site in United Kingdom.
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 5 inclusion and 19 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 22 Jan 2026. 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 Kingdom. 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 flow-mediated dilation (time frame: 6 months). 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 NCT06145087, which also lists 1 linked publication.
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 22 Jan 2026.