Back to resultsEvaluating Benefit of Peptide Based Diet in Obese HEN Patients
Primary Purpose
Obesity
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peptamen Intense VHP, Nestlé Health Science, Switzerland
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Tube feeding, Obesity, Body mass
Eligibility Criteria
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).
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peptamen Intense in obese home enteral nutrition patients after stroke
Arm 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.
Outcomes
Primary Outcome Measures
Change in body weight
Change in body weight, measured in kg
Secondary Outcome Measures
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
Change in systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure, measured in mmHg
Change in HbA1c
Change in hemoglobin A1c, measured in percentage
Change in c-peptide
Change in c-peptide serum levels, measured in ng/mL
Change in total cholesterol
Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Change in HDL
Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.
Change in LDL
Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.
Change in triglycerides
Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.
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.
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.
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.
Change in hand grip strength
Change in hand grip strength, measured by dynamometer.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05080699
Brief Title
Evaluating Benefit of Peptide Based Diet in Obese HEN Patients
Official Title
Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Tube feeding, Obesity, Body mass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peptamen Intense in obese home enteral nutrition patients after stroke
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Peptamen Intense VHP, Nestlé Health Science, Switzerland
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Description
Change in body weight, measured in kg
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in lean body mass
Description
Change in lean body mass, measured as the difference between total body weight and body fat weight reported in percentage
Time Frame
Baseline, 12 weeks
Title
Change in systolic and diastolic blood pressure
Description
Change in systolic and diastolic blood pressure, measured in mmHg
Time Frame
Baseline, 12 weeks
Title
Change in HbA1c
Description
Change in hemoglobin A1c, measured in percentage
Time Frame
Baseline, 12 weeks
Title
Change in c-peptide
Description
Change in c-peptide serum levels, measured in ng/mL
Time Frame
Baseline, 12 weeks
Title
Change in total cholesterol
Description
Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Time Frame
Baseline, 12 weeks
Title
Change in HDL
Description
Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.
Time Frame
Baseline, 12 weeks
Title
Change in LDL
Description
Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.
Time Frame
Baseline, 12 weeks
Title
Change in triglycerides
Description
Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.
Time Frame
Baseline, 12 weeks
Title
Change in percent goal calories provided with enteral nutrition
Description
Change in percent goal calories provided with enteral nutrition , measured percent of calorie provided with enteral nutrition from the estimated goal.
Time Frame
Baseline, 12 weeks
Title
Change in percent goal proteins provided with enteral nutrition
Description
Change in percent goal proteins provided with enteral nutrition , measured percent of protein provided with enteral nutrition from the estimated goal.
Time Frame
Baseline, 12 weeks
Title
Change in tube feeding tolerance
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in hand grip strength
Description
Change in hand grip strength, measured by dynamometer.
Time Frame
Baseline, 12 weeks
Title
Change in diabetes medications
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in anti-hypertensive medications
Description
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.
Time Frame
Baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manpreet Mundi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Evaluating Benefit of Peptide Based Diet in Obese HEN Patients
We'll reach out to this number within 24 hrs