Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Mayo Clinic

Status: Invitation-only

Conditions: Obesity

Treatments: Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland

Study type: Interventional

Funder types: Other

Identifiers

NCT05080699

20-012322

Details and patient eligibility

About

The purpose of this study is to assess the effects of a low energy, high protein tube feeding formula on body weight in tube fed patients who are obese. It will also assess study formula tolerance as well as impact of the study formula on lean body mass, blood pressure, blood sugar and lipids.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Home Enteral Nutrition (HEN) patient receiving at least 90% of energy needs from enteral nutrition.
• BMI > 30.
• History of stroke.
• Weight stable over the past month.

Exclusion criteria

• Diagnosis of cancer undergoing active treatment (chemotherapy, radiation, immunotherapy).
• Life expectancy of less than 6 months.
• Stage IV or higher kidney disease (GFR < 30).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Peptamen Intense in obese home enteral nutrition patients after stroke

Experimental group

Description:

Subjects currently enrolled in Mayo Clinic Home Enteral Nutrition (HEN) program and anticipated to require tube feedings to provide 90% or more of feeding needs will be placed on a Peptamen Intense VHP for up to 12 weeks.

Treatment:

Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland