Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-23
Brief Title:
Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure
Sponsor:
USANA Health Sciences
Organization:
USANA Health Sciences
Study Overview
Official Title:
An Evaluation of the Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Normal Blood Pressure in Normal Healthy Individuals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure In this study safety and tolerability will be assessed among otherwise healthy normotensive individuals
Detailed Description:
The objective of this study is to evaluate the safety of 2 dietary supplement beverage formulations in healthy normotensive individuals The study period will be 29 days in length during which we will monitor and catalogue the blood pressure BP heart rate HR comprehensive metabolic panel CMP complete blood count CBC as well as self-reported side effects of all subjects on a daily basis Note that each beverage will be evaluated at multiple doses Beverage 1 will be monitored at a low medium and high dose where the medium and high dose is quantitatively twice 2X and thrice 3X the low dose 1X respectively Similarly we will evaluate Beverage 2 at a low dose and high dose where the high dose is quantitatively twice 2X of the low dose 1X A placebo treatment will also be incorporated into this study as well As such there will be 6 groups in this study Three subjects will be assigned to each treatment group for a total of 18 subjects
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