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Dietary Cholesterol and Adipose Tissue Inflammation

NCT03729141 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-11-04

No results posted yet for this study

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.

Conditions

  • Cholesterol

Interventions

DIETARY_SUPPLEMENT

Added Cholesterol

Participants assigned to the added cholesterol group will receive snacks containing added cholesterol (1g/day) for 3 weeks prior to surgery.

OTHER

No Added Cholesterol

Participants assigned to the no added cholesterol group will receive snacks containing no added cholesterol for 3 weeks prior to surgery.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Richard Weinberg, MD · Wake Forest University Health Sciences

  • John Parks, Ph.D · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729141 on ClinicalTrials.gov