Investigating a supplement's effects on vascular function in aging
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)
This study is testing whether a dietary supplement can improve blood vessel health in people over 40 to see if it helps them age better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Surrey Academic / other |
| Locations | 2 sites (Guildford and 1 other locations) |
| Trial ID | NCT06145087 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of the NOVOS Core supplement on vascular function in individuals over 40 years old. It focuses on how dietary supplements may influence various aging mechanisms that affect cardiovascular health. Participants will be randomly assigned to receive either the supplement or a placebo, and their vascular function will be monitored over a short to intermediate term. The study seeks to provide insights into how such supplements can potentially improve healthy aging and cardiovascular performance.
Who should consider this trial
Good fit: Ideal candidates are generally healthy individuals over 40 years old with a body mass index greater than 20 kg/m2 and systolic blood pressure of at least 120 mmHg.
Not a fit: Patients with unstable cardiovascular diseases or acute infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary interventions that enhance vascular health and promote healthy aging.
How similar studies have performed: While there is emerging evidence supporting dietary supplements in improving aging-related conditions, the specific effects of the NOVOS Core supplement on vascular function remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 Exclusion Criteria: * 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. * 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.
Where this trial is running
Guildford and 1 other locations
- University of Surrey — Guildford, United Kingdom (Recruiting)
- University of Surrey — Guildford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Mariam Bapir, PhD
- Email: cardiovascular@surrey.ac.uk
- Phone: +44 (0) 1483 68 8979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.