Tier 2 — strong
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 trial registry record and University of Surrey study protocol V5.0
2024
Protocol version 5.0, 23 February 2024; internal reference STAMINA_Protocol_V4.0
Bibliography
- Trial registry
- View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
- Funding
- Verbatim from the protocol funding table: funder "AgeLessSciences, a Public Benefit Corporation, Kris Verburgh, PhD CEO"; financial and non-financial support given: "Charitable donation to Prof. Heiss plus provision of supplement and placebo".
- Competing interests
- The manufacturer of the tested product funded the study through a charitable donation to the chief investigator and supplied both the active product and the placebo. The sponsor of record is the University of Surrey and the investigators are academic staff, but the funding relationship with the product manufacturer is direct and must be disclosed alongside any result.
Study snapshot
| Design | Randomised, double-blind (quadruple-masked), placebo-controlled, parallel-group intervention study with an acute phase and a six-month intermediate phase. Two participant visits: measurements before and two hours after the first dose, then repeated at the final visit. |
|---|---|
| Model | Healthy middle-aged adults, all sexes, adult and older adult age groups. Single site: University of Surrey, Guildford GU2 7XH, United Kingdom. |
| Sample | Planned 60 (30 supplement, 30 placebo); 61 randomised; 43 completers. |
| Intervention | Daily NOVOS Core supplement or matched placebo for up to six months, both provided by AgeLess Sciences LLC. Participants received two phone calls during the study to support compliance. |
| Duration | Acute two-hour post-dose assessment on day one, then daily supplementation for six months with vascular exams and one blood draw repeated at the final visit. |
| Endpoints | Primary: change in flow-mediated dilation measured by ultrasound (percent) at 6 months; Secondary: change in systolic and diastolic blood pressure (mmHg); Secondary: change in total, LDL and HDL cholesterol (mmol/L); Secondary: change in arterial stiffness measured as pulse wave velocity (m/s); Secondary: change in daily walking distance measured by personal smartphone; Secondary: change in calculated 10-year cardiovascular risk (ESC SCORE); Tertiary: changes in blood biomarkers of ageing including DNA damage |
What the study showed, in plain terms
Key findings
What this study can and cannot tell us
Editorial review
Reviewed by the Biohack Blueprint research team
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