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Completed

NCT Number: NCT05348395

Monocyte Priming When Consuming a Western Diet

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

The goal is to challenge metabolically healthy human subjects with a high-calorie, Western diet for 8 weeks to identify the metabolite(s) responsible for monocyte priming and use redox proteomics, RNAseq and Chipseq to determine the genes and pathways involved in monocyte priming in humans. To reflect some key components of the typical Western intake, the Study Team will compose the diet to be high in saturated fat (15% of total energy intake) and fructose (14% of total energy intake) with excess energy intake that is 25% higher than estimated total energy expenditure. Participants will complete a run-in phase where weight stability will be achieved on the control diet. No outcome measures will be collected from the run-in phase. After weight is stabilized during the run-in period, participants will enter the experimental phase of the dietary intervention, where overfeeding will begin with additional calories provided by the key nutrients as noted above. Participants will be monitored throughout the feeding trial. After completion of the 8-week overfeeding period, individuals will be allowed to return to a normal dietary intake. All study participants will be given access to counseling for weight reduction should it be needed following the overfeeding period.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline (experimental phase)

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

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

    Time frame: Week 8 (experimental phase)

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

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Mechanism of Monocyte Priming in Humans - a Feeding Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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