Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515912
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Ketogenic Diet in Healthy Adults With Differing BMI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Ketogenic Diet Blood Lipids and Heart Health in Healthy Adults With Differing BMI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index BMI in the range for obesity The main questions it aims to answer are
Does the ketogenic diet cause larger increases in bad cholesterol low density lipoprotein-cholesterol in adults with a healthy BMI compared to adults with BMI in the range for obesity
Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity
Participants will
Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
Visit the metabolic kitchen daily Monday-Friday to pick up meals
Attend 5 fasting visits at the Clinical Research Center for testing
Does the ketogenic diet cause larger increases in bad cholesterol low density lipoprotein-cholesterol in adults with a healthy BMI compared to adults with BMI in the range for obesity
Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity
Participants will
Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
Visit the metabolic kitchen daily Monday-Friday to pick up meals
Attend 5 fasting visits at the Clinical Research Center for testing
Detailed Description:
This is a controlled feeding study investigating if four weeks on the ketogenic diet will cause differential alterations in blood lipids and lipoproteins vascular health as measured by fasting flow mediated dilation FMD and mechanistic markers of lipid metabolism in adults with normal weight when compared to adults with obesity Outcomes will be measured at both the beginning and end of the study on two consecutive days for a total of four clinic appointments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None