Experimental diet for Heart Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Wake Forest University Health Sciences, Winston-Salem, NC
Heart Diseases
Experimental diet - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

To determine the mechanism of monocyte priming in humans, the study team will conduct a complete feeding trial in normal weight and metabolically healthy human subjects (20-45 years of age) using a western diet (WD), characterized as being high-saturated fat, high-fructose, and high-calorie for 8 weeks.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: change in at the endpoint of week 8

Week 8
Measurement of Mitogen-activated protein kinase phosphate 1 (MKP-1) activity
Measurement of Monocyte protein S-glutathionylation
Ribonucleic acid (RNA) analysis

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Experimental diet
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Experimental diet · No Placebo Group · N/A

Experimental diet
Other
Experimental Group · 1 Intervention: Experimental diet · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in at the endpoint of week 8
Closest Location: Wake Forest University Health Sciences · Winston-Salem, NC
2008First Recorded Clinical Trial
4 TrialsResearching Heart Diseases
423 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,915,159 Total Patients Enrolled
847 Trials studying Heart Diseases
32,429,250 Patients Enrolled for Heart Diseases
Wake Forest University Health SciencesLead Sponsor
1,100 Previous Clinical Trials
1,128,995 Total Patients Enrolled
6 Trials studying Heart Diseases
737 Patients Enrolled for Heart Diseases
National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,527 Total Patients Enrolled
18 Trials studying Heart Diseases
3,202 Patients Enrolled for Heart Diseases
Jamy Ard, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
318 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to communicate in English.
You have a normal body mass index.
You are able to eat the prescribed diet.
You are a non-smoker.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.