Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Manpreet Mundi, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Tube feeding; Body mass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 20-012322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No