Last updated: November 17, 2023
Sponsor: University of Surrey
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
"NOVOS Core" supplement
Placebo
Clinical Study ID
NCT06145087
STAMINA_Protocol_V4.0
Ages > 40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
- Generally healthy. (Note: those with stable conditions that do not interfere with thestudy 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
Exclusion Criteria:
- Symptoms of acute infection
- Cardiac arrhythmias
- Active malignancy
- Clinical signs or symptoms of unstable cardiovascular disease (coronary arterydisease, lower extremity artery disease, cerebrovascular disease). These includeangina pectoris, dyspnoea, palpitation, syncope, claudication, active vasoactivemedication.
- Women who have been pregnant in the last three months, currently pregnant, preparingto become pregnant during the study, or breastfeeding.
- Those that have undergone a change in hormone-based therapies such as, but not limitedto, oral contraceptive pills or progesterone pills within the last 2 months.Progesterone releasing devices are considered hormone-based therapy. Spironolactone isnot 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 thatwould interfere with their ability to understand and follow the requirements of thestudy in the opinion of the principal investigator.
- Subjects with or who have recently experienced traumatic injury, infections, or majorsurgery at the discretion of the qualified investigator.
- Subjects who are likely to start taking drugs/medication on a continuous basis or thatwill undergo surgery during the trial.
- Subjects engaged in donation or who were recipients of blood products within 90 daysbefore the start of the study.
- Subjects with alcohol use of more than 2 alcoholic beverages per day within the pastmonth.
- Subjects participated in a clinical trial with a medicinal, supplemental,nutraceutical or drug within the past two months prior to the first dose in thecurrent study.
- If participants take fish oil supplements, they will be asked to stop takingthese 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, hyaluronicacid, ginger extract, pterostilbene, lithium). Participants will be asked to stoptaking 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 startof trial and during the trial.
- Subjects taking high-dose niacin (nicotinic acid), high-dose vitamin B3, high-dosenicotinamide (niacinamide) within 21 days before the start of the trial. Participantswill be asked to stop taking these supplements 21 days before the start of trial andduring the trial. .
- Subjects with clinically significant abnormal laboratory results at screening. Knownallergy/intolerance to any of the components in the supplement product.
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: "NOVOS Core" supplement
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
October 31, 2024
Connect with a study center
University of Surrey
Guildford, GU2 7XH
United KingdomActive - Recruiting


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