Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03729934
Status:
WITHDRAWN
Last Update Posted:
2021-05-04
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketones Supplementation and Postprandial Lipemia
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Effects of Ketones Supplementation on Postprandial Lipemia
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dissertation for student changed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study determines whether different forms of ketones supplemented prior to a meal lower the triglyceride (fat) content in the blood of overweight and obese individuals. Through a randomized crossover design, participants (n=15) will participate in each of the following three experimental groups (no treatment control, ketone ester, ketone salt), with a 5-14 day washout period between each experimental visit.
Detailed Description:
Previous studies conducted by the investigative team in rodents show that male mice fed a diet containing 30% ketone ester (by kcals) results in greater fecal content and energy loss. While the investigators are unsure of the exact macronutrient content of the energy loss, the hypothesis is that the energy excretion is attributed to lower fat absorption. In the context of this study, it's hypothesized that ketone salts and ketone esters (both available commercially and used for a variety of health-related claims) will reduce the absorption of dietary fats leading to lower circulating triglyceride concentrations if consumed prior to a high-fat mixed meal. If the hypothesis is correct, ketones supplementation could become a valuable strategy to reduce the rise in circulating triglycerides often present in obesity. Triglyceride concentrations in the blood following a meal have been linked to development of cardiovascular disease.
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?: