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Scientists feed volunteers western diet to uncover heart disease origins

NCT ID NCT05348395

Knowledge-focused Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how a high-fat, high-sugar Western diet changes immune cells called monocytes in healthy, normal-weight adults aged 20-45. Eight participants ate a controlled Western diet for 8 weeks. Researchers measured specific proteins and genes in the blood to understand the early steps that might lead to heart disease. The goal was to learn more about the process, not to treat or cure any condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

8 people

The number who actually took part.

Started

Jan 2023

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

heart disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart diseases

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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Other studies related to the condition(s) this trial covers.