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Western Diet for Heart Disease Risk

N/A

Recruiting

Led By Jamy Ard, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 20-45

Be between 18 and 65 years old

Must not have

History of chronic cardiometabolic disease or major risk factor, including diabetes, hypertension, hyperlipidemia, heart disease

Severe pulmonary disease requiring supplemental oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in at the endpoint of week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a Western diet on monocyte priming in humans.

Who is the study for?

This trial is for healthy, normal-weight individuals aged 20-45 who don't smoke or drink excessively. Participants must be free of chronic heart and metabolic diseases, not pregnant or breastfeeding, and able to commit to the study period without working night shifts.

What is being tested?

The trial is testing how a Western diet affects monocyte priming in metabolically healthy adults. The diet is high in saturated fats, fructose, and calories. Subjects will follow this experimental diet strictly for 8 weeks to track changes.

What are the potential side effects?

Potential side effects may include weight gain, increased cholesterol levels, higher blood pressure, and potential negative impacts on heart health due to the nature of the high-fat, high-calorie diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 20 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic condition like diabetes, high blood pressure, high cholesterol, or heart disease.

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I need extra oxygen due to severe lung problems.

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I have had surgery for weight control or liposuction.

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My kidney or liver is not functioning properly.

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I have had a non-skin cancer diagnosis within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in at the endpoint of week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in at the endpoint of week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in at the endpoint of week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Measurement of Monocyte protein S-glutathionylation

Other study objectives

RNA, Messenger

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental dietExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met