Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03729141
Status:
WITHDRAWN
Last Update Posted:
2019-11-04
First Post:
2018-10-26
Brief Title:
Dietary Cholesterol and Adipose Tissue Inflammation
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Cholesterol Mobilization and Adipocyte Function in Humans
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study had funding issues and difficulties with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis increasing dietary cholesterol in humans will increase visceral but not subcutaneous adipocyte size free cholesterol content and inflammatory gene expression
Visceral and abdominal subcutaneous adipose tissue biopsies will be obtained from non-obese subjects undergoing elective abdominal surgery at Wake Forest Baptist Medical Center after 3 weeks of zero control or 1g dietary cholesterol supplementation Blood samples will also be taken before and after 3 weeks of dietary supplementation 0 vs 1g dietary cholesterol to measure plasma lipids levels and ex vivo monocyte chemotaxis Blood will also be used to isolate CD14 monocytes for RNA extraction and storage for future transcriptome studies Measurements of adipocyte size free cholesterol content and inflammatory gene and protein expression in the adipose tissue biopsies to test the hypothesis Adipocytes and the stromal vascular fraction will be isolated and evaluated for CD14 macrophages for RNA extraction and storage for future transcriptome analysis
Visceral and abdominal subcutaneous adipose tissue biopsies will be obtained from non-obese subjects undergoing elective abdominal surgery at Wake Forest Baptist Medical Center after 3 weeks of zero control or 1g dietary cholesterol supplementation Blood samples will also be taken before and after 3 weeks of dietary supplementation 0 vs 1g dietary cholesterol to measure plasma lipids levels and ex vivo monocyte chemotaxis Blood will also be used to isolate CD14 monocytes for RNA extraction and storage for future transcriptome studies Measurements of adipocyte size free cholesterol content and inflammatory gene and protein expression in the adipose tissue biopsies to test the hypothesis Adipocytes and the stromal vascular fraction will be isolated and evaluated for CD14 macrophages for RNA extraction and storage for future transcriptome analysis
Detailed Description:
A Wake Forest School of Medicine Clinical Research Unit-based pilot study will be conducted in which subjects scheduled to undergo elective intra-abdominal surgery at Wake Forest Baptist Medical Center ie cholecystectomy Nissen fundoplication hernia repair etc will be recruited Subjects will be randomly and blindly assigned to receive daily treats cookie brownie or muffin containing either no added cholesterol control or 1g of cholesterolday 04 mgKcal cholesterol for 3 weeks prior to surgery Three weeks for the length of cholesterol supplementation has been chosen because this is within the duration of human egg-consumption studies in which significant elevations in plasma LDL concentrations occurred A blood sample will be taken from each participant at baseline before starting the supplementation period and after 3 weeks of 0 or 1gday cholesterol supplementation at the time of scheduled surgery The blood samples will be used for measurement of lipid profile ex vivo monocyte chemotaxis and for monocyte RNA isolation During surgery abdominal wall subcutaneous adipose tissue and mesenteric visceral adipose tissue samples will be obtained Aliquots of adipose tissue will be fixed overnight for histology and measurement of adipocyte size distribution and CD68 immunostaining flash frozen and stored for cholesterol quantification by gas liquid chromatography extracted to isolate RNA and protein for quantitative real time PCR and immunoblotting of inflammatory gene and protein expression and collagenase digested to isolate adipocytes and stromal vascular cell fraction macrophages which will be used to extract and store RNA for future transcriptome analyses
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