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Monocyte Priming When Consuming a Western Diet

Primary Purpose

Heart Diseases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental diet

About this trial

This is an interventional basic science trial for Heart Diseases focused on measuring heart disease, Western Diet, high-calorie diet

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental diet

Arm Description

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

Outcomes

Primary Outcome Measures

Measurement of Mitogen-activated protein kinase phosphate 1 (MKP-1) activity

Analyze plasma from all subjects for their plasma lipid composition using an unbiased lipidomics approach in order to identify the lipid species responsible for monocyte priming

Secondary Outcome Measures

Measurement of Monocyte protein S-glutathionylation

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.

Full Information

NCT ID

NCT05348395

First Posted

April 21, 2022

Last Updated

March 28, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05348395

Brief Title

Monocyte Priming When Consuming a Western Diet

Official Title

Mechanism of Monocyte Priming in Humans - a Feeding Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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. A total of 30 participants, including 15 men and 15 women, will complete a run-in phase where weight stability will be achieved on the control diet. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Diseases

Keywords

heart disease, Western Diet, high-calorie diet

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental diet

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Experimental diet

Intervention Description

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 Outcome Measure Information:

Title

Measurement of Mitogen-activated protein kinase phosphate 1 (MKP-1) activity

Description

Analyze plasma from all subjects for their plasma lipid composition using an unbiased lipidomics approach in order to identify the lipid species responsible for monocyte priming

Time Frame

change in at the endpoint of week 8

Secondary Outcome Measure Information:

Title

Measurement of Monocyte protein S-glutathionylation

Description

Time Frame

change in at the endpoint of week 8

Other Pre-specified Outcome Measures:

Title

Ribonucleic acid (RNA) analysis

Description

Determine the genes and pathways involved in monocyte priming in humans. Quantify mRNA expression of all transcripts in expressed monocytes

Time Frame

change in at the endpoint of week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chelsea Newman, MPH

Phone

336-713-1411

cmnewman@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamy Ard, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chelsea Newman, MPH

Phone

336-713-1411

cmnewman@wakehealth.edu

First Name & Middle Initial & Last Name & Degree

Jamy Ard, MD

First Name & Middle Initial & Last Name & Degree

Reto Asmis, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Our plan to share materials and manage intellectual property will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources.

IPD Sharing Time Frame

before or immediately after publication

IPD Sharing Access Criteria

upon request

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Monocyte Priming When Consuming a Western Diet

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