CholesterolNCT03729141
Dietary Cholesterol and Adipose Tissue Inflammation
A study testing Added Cholesterol and No Added Cholesterol in people with Cholesterol, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesterol
- What is being tested?
- Added Cholesterol and No Added Cholesterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:18 to 70 years old
- Operated on by one of the study team surgeons at Wake Forest Baptist Medical Center.
Who cannot join
- 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
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- Diabetes mellitus requiring treatment with oral agents or insulin
- Taking Questran, Colestid, or Zetia
- BMI over 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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 (i.e., 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 cholesterol/day (~0.4 mg/Kcal 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 1g/day 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.
- Conditions
- Cholesterol
- Being tested
- Added Cholesterol, No Added Cholesterol
- Keywords
- Cholesterol, Adipocyte, Macrophage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Added CholesterolDietary supplement
Participants assigned to the added cholesterol group will receive snacks containing added cholesterol (1g/day) for 3 weeks prior to surgery.
No Added CholesterolOther
Participants assigned to the no added cholesterol group will receive snacks containing no added cholesterol for 3 weeks prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Added Cholesterol | Experimental | Not described Receives: Dietary Supplement: Added Cholesterol |
| No Added Cholesterol | Active comparator | Not described Receives: Other: No Added Cholesterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma total
Plasma will be used to measure plasma total
Measured: up to 6 weeks after surgery
Adipocyte size
Adipocyte size will be evaluated by histology by microscopic examination and morphometry.
Measured: within 6 weeks after surgery
Lipoprotein cholesterol levels
Plasma will be used to measure lipoprotein cholesterol levels.
Measured: up to 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study startOct 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Study had funding issues and difficulties with recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholesterolStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Weinberg, MD, Principal investigator, Wake Forest University Health SciencesJohn Parks, Ph.D, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729141
- Sponsor's protocol ID
- IRB00023743
- Status last verified
- Jul 2019
- First submitted
- 26 Oct 2018
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol Mobilization and Adipocyte Function in Humans
- ClinicalTrials.gov ID
- NCT03729141
- Acronym / sponsor ID
- IRB00023743
- Conditions
- Cholesterol
- Keywords
- Cholesterol, Adipocyte, Macrophage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study had funding issues and difficulties with recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., 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 cholesterol/day (~0.4 mg/Kcal 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 1g/day 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Added Cholesterol | Experimental | Dietary Supplement: Added Cholesterol |
| No Added Cholesterol | Active comparator | Other: No Added Cholesterol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age:18 to 70 years old
- Operated on by one of the study team surgeons at Wake Forest Baptist Medical Center.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Added CholesterolParticipants assigned to the added cholesterol group will receive snacks containing added cholesterol (1g/day) for 3 weeks prior to surgery. | Dietary supplement | Added Cholesterol |
| No Added CholesterolParticipants assigned to the no added cholesterol group will receive snacks containing no added cholesterol for 3 weeks prior to surgery. | Other | No Added Cholesterol |
Primary outcome
Plasma total
Time frame: up to 6 weeks after surgery
Plasma will be used to measure plasma total
Adipocyte size
Time frame: within 6 weeks after surgery
Adipocyte size will be evaluated by histology by microscopic examination and morphometry.
Lipoprotein cholesterol levels
Time frame: up to 6 weeks after surgery
Plasma will be used to measure lipoprotein cholesterol levels.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Weinberg, MD principal investigator
Wake Forest University Health Sciences
John Parks, Ph.D study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Added Cholesterol and No Added Cholesterol in people with Cholesterol, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma total (time frame: up to 6 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.