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Monocyte Priming When Consuming a Western Diet

NCT05348395 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-03-06

Study results available
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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.

Conditions

  • Heart Diseases

Interventions

OTHER

Experimental diet

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jamy Ard, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2024-10-11
Completion
2024-10-11

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 NCT05348395 on ClinicalTrials.gov