Heart Diseases
Conditions
Keywords
heart disease, Western Diet, high-calorie diet
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. 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.
Interventions
OTHERExperimental 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
Wake Forest University Health Sciences
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Mitogen-activated Protein Kinase Phosphate 1 (MKP-1) Activity | Baseline (experimental phase) | Analyze plasma from all subjects for their plasma lipid composition using ELISA to quantify MKP-1 protein in blood monocytes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ribonucleic Acid (RNA) Analysis | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJamy Ard, MD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 6 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
None listed