Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland

• Registration Number: NCT05080699
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-18
• Study Start: 2023-03-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 12

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peptamen Intense in obese home enteral nutrition patients after stroke	Peptamen Intense VHP, Nestlé Health Science, Switzerland	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.

Primary Outcome Measures

Name	Time	Method
Change in body weight	Baseline, 3 months	Change in body weight, measured in kg

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol	Baseline, 12 weeks	Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Change in LDL	Baseline, 12 weeks	Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.
Change in lean body mass	Baseline, 12 weeks	Change in lean body mass, measured as the difference between total body weight and body fat weight reported in percentage
Change in systolic and diastolic blood pressure	Baseline, 12 weeks	Change in systolic and diastolic blood pressure, measured in mmHg
Change in HbA1c	Baseline, 12 weeks	Change in hemoglobin A1c, measured in percentage
Change in c-peptide	Baseline, 12 weeks	Change in c-peptide serum levels, measured in ng/mL
Change in HDL	Baseline, 12 weeks	Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.
Change in percent goal calories provided with enteral nutrition	Baseline, 12 weeks	Change in percent goal calories provided with enteral nutrition , measured percent of calorie provided with enteral nutrition from the estimated goal.
Change in percent goal proteins provided with enteral nutrition	Baseline, 12 weeks	Change in percent goal proteins provided with enteral nutrition , measured percent of protein provided with enteral nutrition from the estimated goal.
Change in triglycerides	Baseline, 12 weeks	Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.
Change in diabetes medications	Baseline, 12 weeks	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.
Change in tube feeding tolerance	Baseline, 12 weeks	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.
Change in hand grip strength	Baseline, 12 weeks	Change in hand grip strength, measured by dynamometer.
Change in anti-hypertensive medications	Baseline, 12 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States