- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05348395
Monocyte Priming When Consuming a Western Diet
Mechanism of Monocyte Priming in Humans - a Feeding Trial
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chelsea Newman, MPH
- Phone Number: 336-713-1411
- Email: cmnewman@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Chelsea Newman, MPH
- Phone Number: 336-713-1411
- Email: cmnewman@wakehealth.edu
-
Principal Investigator:
- Jamy Ard, MD
-
Sub-Investigator:
- Reto Asmis, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 20-45
- Planning to be available for the entire study period
- Able to speak and read English
- Normal weight (body mass index 18.5-24.9 kg/m2)
- Able to eat the prescribed diet
- Non-smoker
Exclusion Criteria:
- Excessive alcohol consumption
- History of chronic cardiometabolic disease or major risk factor, including diabetes, hypertension, hyperlipidemia, heart disease
- History of prior surgical procedure for weight control or liposuction
- Use of weight loss medications in previous 6 months
- Recent self-reported weight change
- Severe pulmonary disease requiring supplemental oxygen
- Abnormal renal or liver function
- History of non-skin cancer in the past 5 years
- Regular use of medications (prescribed or over-the-counter) that affect blood pressure, lipids, glucose, inflammation, or body weight
- Works night shifts
- Exercise per week > 420 minutes total for moderate activity or > 210 minutes for vigorous activity
- Any medical or behavioral indication that would make participation unsafe based on the judgement of the study physician
- Pregnant or lactating women
- Known or discovered intolerances, allergies or difficulty consuming any of the foods included in the study diets
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental diet
The experimental diet will provide 15% of calories from saturated fat and 14% of calories from fructose with a goal of providing 1.25x total energy needs
|
Participants that successfully complete the run-in phase will participate in the experimental diet for 8 weeks of feeding.
The Participants' adherence will be monitored using direct observation, written daily food diaries, and food waste inventory (i.e., participants are trained to estimate portion of uneaten foods).
Participants will be asked to eat one meal onsite 2-3 weekdays (e.g., Monday, Wednesday, and Friday), at which time they will receive meals and snacks for the remainder of that day and enough until the next scheduled visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Mitogen-activated protein kinase phosphate 1 (MKP-1) activity
Time Frame: change in at the endpoint of week 8
|
Analyze plasma from all subjects for their plasma lipid composition using an unbiased lipidomics approach in order to identify the lipid species responsible for monocyte priming
|
change in at the endpoint of week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Monocyte protein S-glutathionylation
Time Frame: change in at the endpoint of week 8
|
To identify which proteins alter their S-glutathionylation status (and possibly their expression levels) in response to HCD-induced monocyte priming, and which signaling pathways are altered in these cells. Isolate S-glutathionylated proteins from all samples and subject them to redox proteomics approach to identify S-glutathionylated proteins and to determine the extent and directionality of modifications on their cysteine residues. |
change in at the endpoint of week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ribonucleic acid (RNA) analysis
Time Frame: change in at the endpoint of week 8
|
Determine the genes and pathways involved in monocyte priming in humans.
Quantify mRNA expression of all transcripts in expressed monocytes
|
change in at the endpoint of week 8
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jamy Ard, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00083476
- R01HL153120 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
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.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
Xiao-dong ZhuangRecruitingValvular Heart DiseaseChina
Clinical Trials on Experimental diet
-
Marjukka KolehmainenLund University; Uppsala University; Aarhus University Hospital; University of... and other collaboratorsCompletedCardiovascular Diseases | Insulin Resistance | Type 2 Diabetes | Impaired Glucose Tolerance | Abdominal ObesitySweden, Denmark, Finland, Iceland, Norway
-
University of LausanneUniversity of LiegeCompletedHereditary Fructose IntoleranceBelgium
-
Laval UniversityCanadian Institutes of Health Research (CIHR); Heart and Stroke Foundation...CompletedCardiovascular DiseasesCanada
-
Chonbuk National University HospitalCompletedFunctional ConstipationKorea, Republic of
-
Universitätsmedizin MannheimCompletedQuality of LifeGermany
-
Milton S. Hershey Medical CenterStanley Medical Research InstituteCompleted
-
Rhode Island HospitalEnrolling by invitationGastrointestinal Diseases | Colitis | Pediatric Disorder | Pediatric Crohns Disease | Procedural SequelaeUnited States
-
Azienda Ospedaliera Specializzata in Gastroenterologia...Dr. Di Stasi Vincenza; Dr. Donvito Rosanna; Dr. Cozzolongo Raffaele; Dr. Giannuzzi... and other collaboratorsNot yet recruiting
-
Société des Produits Nestlé (SPN)CompletedToddlers Bone MetabolismPhilippines
-
Hospital of South West JutlandCompletedWeight Loss | Morbid ObesityDenmark