Effects of a Supplement to Target Ageing Mechanisms on Vascular Function (STAMINA)

Launched by UNIVERSITY OF SURREY · Nov 17, 2023

Keywords

ClinConnect Summary

The STAMINA trial is studying the effects of a dietary supplement called NOVOS Core on blood vessel health in healthy middle-aged adults. As we age, our cardiovascular function can decline, which may lead to various health issues. The researchers want to see if taking this supplement daily for six months can improve blood flow and overall vascular function. They will measure changes in several health markers, including blood pressure, cholesterol levels, and other factors related to heart health.

To participate, individuals need to be generally healthy, over the age of 40, and have a body mass index (BMI) above 20. Those interested will be randomly assigned to either take the NOVOS Core supplement or a placebo (a non-active version) for the duration of the study. Participants will attend two visits for health assessments, including non-invasive tests and blood samples. Throughout the trial, they will also receive follow-up calls to help them stay on track with their daily supplement intake. This study could help us understand how dietary supplements might support healthy aging and cardiovascular function.

Gender

ALL

Eligibility 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.