NCT03729141

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 4, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

October 26, 2018

Last Update Submit

October 30, 2019

Conditions

Cholesterol

Keywords

CholesterolAdipocyteMacrophage

Outcome Measures

Primary Outcomes (3)

  • Plasma total

    Plasma will be used to measure plasma total

    up to 6 weeks after surgery

  • Adipocyte size

    Adipocyte size will be evaluated by histology by microscopic examination and morphometry.

    within 6 weeks after surgery

  • Lipoprotein cholesterol levels

    Plasma will be used to measure lipoprotein cholesterol levels.

    up to 6 weeks after surgery

Other Outcomes (3)

  • Plasma lipid levels

    up to 12 weeks

  • Ex vivo monocyte chemotaxis

    up to 12 weeks

  • Gene expression

    within 20 weeks of surgery.

Study Arms (2)

Added Cholesterol

EXPERIMENTAL
Dietary Supplement: Added Cholesterol

No Added Cholesterol

ACTIVE COMPARATOR
Other: No Added Cholesterol

Interventions

Added CholesterolDIETARY_SUPPLEMENT

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

Added Cholesterol
No Added CholesterolOTHER

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

No Added Cholesterol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:18 to 70 years old
  • Operated on by one of the study team surgeons at Wake Forest Baptist Medical Center.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Richard Weinberg, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • John Parks, Ph.D

    Wake Forest University Health Sciences

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 2, 2018

Study Start

October 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 4, 2019

Record last verified: 2019-07

Locations

US(1)