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Meal Intake for Atherosclerosis (HPL Trial)

N/A

Waitlist Available

Led By Bettina Mittendorfer

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

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

Must have

18 years or older

Be older than 18 years old

Must not have

History of Stroke

Taking Torisel/Temsirolimus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of different types of liquid meals on the body's cells.

Who is the study for?

This trial is for adults who can consume milk-based liquid meals. It's not suitable for those with a history of organ transplant, diabetes, heart disease, high blood pressure, stroke or cancer. Pregnant individuals and those allergic to meal ingredients or on certain medications like Rapamycin/Sirolimus and statins cannot participate.

What is being tested?

The study tests the effects of different protein levels in meals on cardiovascular risk factors. Participants will receive one of three types of liquid meals: low protein, high protein, or low protein with added leucine (which activates mTOR signaling). Blood samples will be taken before and after meal consumption to analyze monocyte and platelet activation.

What are the potential side effects?

Since this trial involves dietary intake rather than drugs, side effects may include digestive discomfort related to the liquid meals consumed. However, specific side effects are not detailed as they depend on individual reactions to diet changes.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

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

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I have had a stroke in the past.

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I am currently taking Torisel (Temsirolimus).

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I have a history of diabetes.

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I am currently taking statin medication.

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I have a history of heart disease.

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I have a history of high blood pressure.

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I have had an organ transplant.

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I am currently taking Rapamycin/Sirolimus.

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I am currently taking Afinitor/Everolimus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Active Control

Group I: Standard protein mealActive Control1 Intervention

Participants will receive a standard protein meal, containing about 10% of energy as protein

Group II: High protein mealActive Control1 Intervention

Participants will receive a high protein meal, containing about 50% of energy as protein

Group III: Low protein meal + leucineActive Control1 Intervention

Participants will receive a standard protein meal, containing about 10% of energy as protein to which leucine has been added to match the total leucine content of the high protein meal

0 / 10Eligibility criteria met