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Lipid Metabolism Modulator

High Saturated Fat Diet for Peripheral Vascular Disease

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Healthy adults aged 18-40 years

English-speaking only

Must not have

Healthy individuals under 18 years or over 40 years of age

Heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how artery and microvascular function is affected by eating fats with long or medium chain fatty acids.

Who is the study for?

This trial is for healthy, English-speaking adults aged 18-40 who are not pregnant. It's not suitable for those with blood pressure or heart rate outside of normal ranges, current tobacco users, lactose intolerant individuals, anyone with open mouth sores or wounds, diabetes patients, people with coronary artery disease or high cholesterol, recent chemotherapy patients, and non-English speakers.

What is being tested?

The study aims to see how a high fat meal affects the peripheral vascular function in participants. They will eat meals rich in long chain fatty acids (which may increase plasma ceramides) versus medium chain fatty acids (control). Their artery function and microvascular endothelial function will be measured using laser Doppler flowmetry and the CytoCam device.

What are the potential side effects?

While specific side effects aren't listed for consuming a single high-fat meal as part of this study, potential short-term reactions could include gastrointestinal discomfort such as bloating or indigestion.

Eligibility Criteria

Inclusion Criteria

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

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I am a healthy adult between 18 and 40 years old.

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I speak English.

Exclusion Criteria

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

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I am under 18 or over 40 years old and healthy.

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I have heart failure.

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I have been diagnosed with coronary artery disease.

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I have diabetes.

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I have high blood pressure.

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I have not had chemotherapy in the last 6 months.

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I have visible sores or wounds in my mouth.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Endothelial-Dependent Total Vessel Density

Percentage of Cardiovascular Conductance

Secondary study objectives

Reactive Hyperemia

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Long Chain Fatty Acid High Fat MealExperimental Treatment1 Intervention

This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a long chain fatty acid high fat meal.

Group II: Medium Chain Fatty Acid High Fat MealActive Control1 Intervention

This arm will assess the effect of increased plasma ceramide on peripheral microvascular function after consuming a medium chain fatty acid high fat meal.

0 / 10Eligibility criteria met