Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04677920
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2020-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
The HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
HCES
Brief Summary:
The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.
Detailed Description:
Linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin and mitochondria.
The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims
Aim 1) To assess muscle biopsy yield with a micro biopsy needle
Aim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function
Aim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples
Aim 4) To determine the effect of short-term healthy cookies made with linoleic acid rich oil on measures of mitochondrial function in white blood cells and muscle as well as their relationship to lipid composition of the blood, markers of metabolic health and markers of mitochondria biogenesis
The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims
Aim 1) To assess muscle biopsy yield with a micro biopsy needle
Aim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function
Aim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples
Aim 4) To determine the effect of short-term healthy cookies made with linoleic acid rich oil on measures of mitochondrial function in white blood cells and muscle as well as their relationship to lipid composition of the blood, markers of metabolic health and markers of mitochondria biogenesis
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?:
False
Is an FDA AA801 Violation?: