Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145087
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-03-07
Brief Title:
Effects of a Supplement to Target Ageing Mechanisms on Vascular Function STAMINA
Sponsor:
University of Surrey
Organization:
University of Surrey
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAMINA
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 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 n30 or placebo n30 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
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 n30 or placebo n30 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None