Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Study Overview
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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.

Official Title
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Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peptamen Intense in obese home enteral nutrition patients after stroke<br>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. | Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Change in body weight, measured in kg | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lean body mass | Change in lean body mass, measured as the difference between total body weight and body fat weight reported in percentage | Baseline, 12 weeks | 
| Change in systolic and diastolic blood pressure | Change in systolic and diastolic blood pressure, measured in mmHg | Baseline, 12 weeks | 
| Change in HbA1c | Change in hemoglobin A1c, measured in percentage | Baseline, 12 weeks | 
| Change in c-peptide | Change in c-peptide serum levels, measured in ng/mL | Baseline, 12 weeks | 
| Change in total cholesterol | Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood. | Baseline, 12 weeks | 
| Change in HDL | Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood. | Baseline, 12 weeks | 
| Change in LDL | Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood. | Baseline, 12 weeks | 
| Change in triglycerides | Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood. | Baseline, 12 weeks | 
| Change in percent goal calories provided with enteral nutrition | Change in percent goal calories provided with enteral nutrition , measured percent of calorie provided with enteral nutrition from the estimated goal. | Baseline, 12 weeks | 
| Change in percent goal proteins provided with enteral nutrition | Change in percent goal proteins provided with enteral nutrition , measured percent of protein provided with enteral nutrition from the estimated goal. | Baseline, 12 weeks | 
| Change in tube feeding tolerance | Change in tolerance to tube feeding, measured by follow up questionnaire about symptoms of GI intolerance; namely, diarrhea, constipation, abdominal(stomach/tummy/belly) pain or discomfort, nausea and vomiting. The scale used will asses the frequency of these symptoms using the following terms: not at all, rarely, sometimes, often, and very often with not at all being least frequent and very often being most frequent presence of the concerning symptom. | Baseline, 12 weeks | 
| Change in hand grip strength | Change in hand grip strength, measured by dynamometer. | Baseline, 12 weeks | 
| Change in diabetes medications | Change in diabetes medications, measured by capturing any change in diabetes medications (when applicable) in terms of new medications added, or discontinuation or change in doses of current medications. | Baseline, 12 weeks | 
| Change in anti-hypertensive medications | Change in hypertension medications, measured by capturing any change in hypertension medications (when applicable) in terms of new medications added, or discontinuation or change in doses of current medications. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tube feeding, Obesity, Body mass