Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06145087
Other study ID # STAMINA_Protocol_V4.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date October 31, 2024

Study information

Verified date November 2023
Source University of Surrey
Contact Mariam Bapir, PhD
Phone +44 (0) 1483 68 8979
Email cardiovascular@surrey.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 declines and large and small blood vessels change in various and complex ways and these changes may lead to many age-related diseases. On a molecular level, there are many mechanisms that are associated with ageing including cellular senescence, loss of proteostasis, altered cellular communication, genomic instability, epigenetic alterations, telomere shortening, deregulated nutrient sensing, stem cell exhaustion and protein crosslinking. Animal and human studies suggest that dietary supplements may be able to affect these mechanisms. What the effect of the NOVOS Core supplement is on cardiovascular functions is not known. The aim of the present study is to investigate the short and intermediate term effects of a supplement mix designed to target ageing mechanism on vascular function in healthy middle-aged subjects. (STAMINA Study) The hypothesis is that the supplement will lead to acute and sustained changes in biomarkers of vascular function and health. 60 healthy middle-aged people will be recruited and randomly assigned to either daily intake of the NOVOS Core supplement (n=30) or placebo (n=30) for up to 6 months (3-6). The supplement (NOVOS Core) is a commercially available product and has 12 ingredients. It was developed and is provided together with the placebo by AgeLess Sciences LLC, a Public Benefit Corporation. The study will require 2 visits by participants during which non-invasive vascular exams will be performed, venous blood taken and spot urine sample collected. The primary endpoint is change in flow-mediated dilation, secondary endpoints are change in blood pressure, cholesterol, arterial stiffness, microvascular function cardiovascular risk SCORE and daily walking distance. Tertiary endpoints are changes in biomarkers of ageing as assessed in blood samples including DNA damage. In addition, we will assess anxiety, depressive feelings, happiness, well-being and the diet with several questionnaires. Measurements will be taken on the first day before and 2 hours after ingestion of the first supplement or placebo. Participants will consume the supplement or placebo for 6 months and vascular exams and one blood draw will be repeated during the final visit. During the time, participants will receive 2 phone calls to improve compliance.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 31, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
"NOVOS Core" supplement
The supplement mix (15 g) is supplied as a powder to be mixed in water or other beverages like tea or coffee once per day.
Placebo
The placebo mix (15 g) is supplied as a powder to be mixed in water or other beverages like tea or coffee.

Locations

Country Name City State
United Kingdom University of Surrey Guildford
United Kingdom University of Surrey Guildford

Sponsors (1)

Lead Sponsor Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in blood cell DNA damage Change in blood cell DNA damage (gH2AX with immofluorescence) 6 months
Other Change in well-ness scores Change in well-ness scores (Oxford Happiness Questionnaire) 6 months
Primary Change in flow-mediated dilation Change in flow-mediated dilation with ultrasound (%) 6 months
Secondary Change in systolic blood pressure Change in systolic blood pressure (mmHg) 6 months
Secondary Change in diastolic blood pressure Change in diastolic blood pressure (mmHg) 6 months
Secondary Change in cholesterol Change in cholesterol including LDL, HDL, total cholesterol, oxLDL 6 months
Secondary Change in total cholesterol Change in total cholesterol (mml/l) 6 months
Secondary Change in LDL cholesterol Change in LDL cholesterol (mmol/l) 6 months
Secondary Change in HDL cholesterol Change in HDL cholesterol (mmol/l) 6 months
Secondary Change in oxLDL cholesterol Change in oxLDL cholesterol (mmol/l) 6 months
Secondary Change in arterial stiffness Change in pulse wave velocity (m/s) 6 months
Secondary Change in microvascular diameter Change in microvascular diameter with optical coherence tomography angiography (um) 6 months
Secondary Change in microvascular dilation Change in microvascular dilation with optical coherence tomography angiography (um) after forearm occlusion (%) 6 months
Secondary Change in daily walking distance Change in daily walking distance in kilometers as measure by personal smartphone 6 months
Secondary Change in cardiovascular risk Change in calculated 10 year cardiovascular risk (European Society of Cardiology Systematic Coronary Risk Evaluation [ESC SCORE]) 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05596474 - Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue N/A
Active, not recruiting NCT05203848 - Community Dance Program (CDP) for Older Adults Phase 1
Not yet recruiting NCT06455982 - Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism N/A
Completed NCT04084457 - Investigating the Effects of Daily Consumption of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance N/A
Recruiting NCT05006261 - A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II N/A
Active, not recruiting NCT04262674 - Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults N/A
Completed NCT02218411 - Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults. Phase 1
Active, not recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Completed NCT05213091 - The Effect of Otago Exercises in the Elderly N/A
Active, not recruiting NCT04904068 - Functional Neuroimaging in Parkinson's Disease
Completed NCT04348162 - Food Anthocyanins and Flavanols as a Strategy for a Healthy Ageing: Cardiovascular Health and Cognitive Performance N/A
Completed NCT05941143 - Effect of Mindfulness on EEG Brain Activity for Cognitive and Psychological Well-being in the Elderly N/A
Completed NCT06022094 - Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence N/A
Active, not recruiting NCT06162871 - Social Participation and Healthy Aging N/A
Completed NCT05207501 - Effects of Different Moderate-intensity Exercise Methods on Health in the Elderly N/A
Recruiting NCT04986787 - Novel, Individualized Brain Stimulation, Network-based Approaches to Improve Cognition N/A
Completed NCT05933798 - China Pilot of ICOPE (Integrated Care for Older People) in Chaoyang N/A
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Completed NCT04786665 - Strawberries, Cognition, and Vascular Health N/A
Completed NCT05290571 - Modified Otago Exercise Program on Balance Performance N/A