Trial Outcomes & Findings for Monocyte Priming When Consuming a Western Diet (NCT NCT05348395)
NCT ID: NCT05348395
Last Updated: 2026-03-06
Results Overview
Analyze plasma from all subjects for their plasma lipid composition using ELISA to quantify MKP-1 protein in blood monocytes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline (experimental phase)
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
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
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.
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|---|---|
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Run-In Phase (10-14 Days)
STARTED
|
8
|
|
Run-In Phase (10-14 Days)
COMPLETED
|
8
|
|
Run-In Phase (10-14 Days)
NOT COMPLETED
|
0
|
|
Experimental Phase (8 Weeks)
STARTED
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8
|
|
Experimental Phase (8 Weeks)
COMPLETED
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7
|
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Experimental Phase (8 Weeks)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
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.
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|---|---|
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Experimental Phase (8 Weeks)
Withdrawal by Subject
|
1
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Baseline Characteristics
Monocyte Priming When Consuming a Western Diet
Baseline characteristics by cohort
| Measure |
Experimental Diet
n=8 Participants
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
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.
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|---|---|
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Age, Continuous
|
34.5 years
STANDARD_DEVIATION 6.7 • n=41 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=41 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
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Race (NIH/OMB)
White
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7 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
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8 participants
n=41 Participants
|
PRIMARY outcome
Timeframe: Baseline (experimental phase)Analyze plasma from all subjects for their plasma lipid composition using ELISA to quantify MKP-1 protein in blood monocytes.
Outcome measures
| Measure |
Experimental Diet
n=8 Participants
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
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.
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|---|---|
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Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity
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6.71 ng/mg protein
Standard Deviation 1.33
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PRIMARY outcome
Timeframe: Week 8 (experimental phase)Analyze plasma from all subjects for their plasma lipid composition using ELISA to quantify MKP-1 protein in blood monocytes.
Outcome measures
| Measure |
Experimental Diet
n=7 Participants
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
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.
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|---|---|
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Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity
|
5.91 ng/mg
Standard Deviation 3.97
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SECONDARY outcome
Timeframe: change in at the endpoint of week 8Population: Samples not taken for this measure due to lack of funding. No further data/samples will be collected in the future.
Determine the genes and pathways involved in monocyte priming in humans. Quantify mRNA expression of all transcripts in expressed monocytes
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: change in at the endpoint of week 8To 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.
Outcome measures
Outcome data not reported
Adverse Events
Experimental Diet
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Diet
n=8 participants at risk
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
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.
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|---|---|
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Gastrointestinal disorders
Nausea
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37.5%
3/8 • Number of events 6 • from baseline through week 8
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Gastrointestinal disorders
Bloating
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37.5%
3/8 • Number of events 3 • from baseline through week 8
|
|
Gastrointestinal disorders
loose bowel movement
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12.5%
1/8 • Number of events 5 • from baseline through week 8
|
|
Gastrointestinal disorders
diarrhea
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25.0%
2/8 • Number of events 4 • from baseline through week 8
|
|
Gastrointestinal disorders
headache
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12.5%
1/8 • Number of events 1 • from baseline through week 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place