- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03729141
Dietary Cholesterol and Adipose Tissue Inflammation
Cholesterol Mobilization and Adipocyte Function in Humans
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age:18 to 70 years old
- Operated on by one of the study team surgeons at Wake Forest Baptist Medical Center.
Exclusion Criteria:
- History of liver disease (e.g., autoimmune hepatitis, Wilson's disease, hemochromatosis, 1 anti-trypsin deficiency), as determined by chart review
- Childs A, B, or C cirrhosis, as determined by chart review
- Present diagnosis/treatment of malignancy other than non-melanoma skin cancer
- Baseline INR > 1.8, as determined by chart review or need for continuous anticoagulation with warfarin or heparin
- Platelets <50,000 as determined by chart review
- Active immunomodulation therapy for chronic inflammatory diseases, including but not limited to rheumatoid arthritis, psoriasis, SLE, sarcoidosis, or inflammatory bowel disease
- Diabetes mellitus requiring treatment with oral agents or insulin
- Taking Questran, Colestid, or Zetia
- BMI over 30
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Added Cholesterol
|
Participants assigned to the added cholesterol group will receive snacks containing added cholesterol (1g/day) for 3 weeks prior to surgery.
|
Active Comparator: No Added Cholesterol
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Participants assigned to the no added cholesterol group will receive snacks containing no added cholesterol for 3 weeks prior to surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma total
Time Frame: up to 6 weeks after surgery
|
Plasma will be used to measure plasma total
|
up to 6 weeks after surgery
|
Adipocyte size
Time Frame: within 6 weeks after surgery
|
Adipocyte size will be evaluated by histology by microscopic examination and morphometry.
|
within 6 weeks after surgery
|
Lipoprotein cholesterol levels
Time Frame: up to 6 weeks after surgery
|
Plasma will be used to measure lipoprotein cholesterol levels.
|
up to 6 weeks after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma lipid levels
Time Frame: up to 12 weeks
|
Blood samples will be collected from subjects at baseline and at the time of surgery in which snacks containing either no added cholesterol or 1g/day added cholesterol were eaten for three weeks prior to surgery.
Plasma lipid levels will be measured.
In addition blood will be used to isolate CD14+ monocytes for RNA extraction and storage for future transcriptome studies.
|
up to 12 weeks
|
Ex vivo monocyte chemotaxis
Time Frame: up to 12 weeks
|
Blood samples will be collected from subjects at baseline and at the time of surgery in which snacks containing either no added cholesterol or 1g/day added cholesterol were eaten for three weeks prior to surgery.
Ex vivo monocyte chemotaxis will be measured.
In addition blood will be used to isolate CD14+ monocytes for RNA extraction and storage for future transcriptome studies.
|
up to 12 weeks
|
Gene expression
Time Frame: within 20 weeks of surgery.
|
Visceral and subcutaneous adipose tissue will be collected from subjects in which snacks containing either no added cholesterol or 1g/day added cholesterol were eaten for three weeks prior to surgery.
Tissue samples will be taken from non-obese participants undergoing elective abdominal surgery to be used to measure inflammatory gene expression.
|
within 20 weeks of surgery.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Weinberg, MD, Wake Forest University Health Sciences
- Study Chair: John Parks, Ph.D, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00023743
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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