Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-03 @ 9:16 PM
Study NCT ID:
NCT04195594
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2019-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
Sponsor:
TRC GEN+ managed by Trans Russian co Cy
Organization:
Study Overview
Official Title:
An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: