Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peptamen Intense in obese home enteral nutrition patients after stroke

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.

Group Type EXPERIMENTAL

Peptamen Intense VHP, Nestlé Health Science, Switzerland

Intervention Type DIETARY_SUPPLEMENT

An enteral formula containing hydrolyzed whey protein, maltodextrin, long-chain triglycerides, medium chain triglycerides (MCT), vitamins and minerals. Compared to standard enteral formula, Peptamen Intense is higher in protein (37 kcal%) and lower in carbohydrates (29 kcal%). The energy content is 1.0 kcal/mL.

Interventions

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Peptamen Intense VHP, Nestlé Health Science, Switzerland

An enteral formula containing hydrolyzed whey protein, maltodextrin, long-chain triglycerides, medium chain triglycerides (MCT), vitamins and minerals. Compared to standard enteral formula, Peptamen Intense is higher in protein (37 kcal%) and lower in carbohydrates (29 kcal%). The energy content is 1.0 kcal/mL.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No