Status:
UNKNOWN
Effects of a Supplement to Target Ageing Mechanisms on Vascular Function (STAMINA)
Lead Sponsor:
University of Surrey
Conditions:
Healthy Aging
Vascular Dilation
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06145087
Start Date
June 1 2023
End Date
October 31 2024
Last Update
November 22 2023
Active Locations (2)
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1
University of Surrey
Guildford, United Kingdom, GU2 7XH
2
University of Surrey
Guildford, United Kingdom, GU2 7XH