Monocyte Priming When Consuming a Western Diet

NCT05348395 | Completed Results DMC

• 2 other identifiers: IRB00083476R01HL153120
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

heart disease; Western Diet; high-calorie diet

Outcome Measures

Primary Outcomes (2)

• Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity

  Analyze plasma from all subjects for their plasma lipid composition using ELISA to quantify MKP-1 protein in blood monocytes.

  Baseline (experimental phase)

• Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity

  Analyze plasma from all subjects for their plasma lipid composition using ELISA to quantify MKP-1 protein in blood monocytes.

  Week 8 (experimental phase)

Secondary Outcomes (1)

• Ribonucleic Acid (RNA) Analysis

  change in at the endpoint of week 8

Other Outcomes (1)

• Measurement of Monocyte Protein S-glutathionylation

  change in at the endpoint of week 8

Study Arms (1)

Experimental diet

EXPERIMENTAL

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

Other: Experimental diet

Interventions

Experimental diet OTHER

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.

Experimental diet

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Elena Boudyguina
• Organization: Advocate Health

Elena.Boudyguina@advocatehealth.org

336-713-1411

Study Officials

• Jamy Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: January 6, 2023
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: before or immediately after publication
• Access Criteria: upon request

Locations

US (1)