Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05080699
Collaborator
(none)
12
1
1
12
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in body weight [Baseline, 3 months]

    Change in body weight, measured in kg

Secondary Outcome Measures

  1. 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

  2. Change in systolic and diastolic blood pressure [Baseline, 12 weeks]

    Change in systolic and diastolic blood pressure, measured in mmHg

  3. Change in HbA1c [Baseline, 12 weeks]

    Change in hemoglobin A1c, measured in percentage

  4. Change in c-peptide [Baseline, 12 weeks]

    Change in c-peptide serum levels, measured in ng/mL

  5. Change in total cholesterol [Baseline, 12 weeks]

    Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.

  6. Change in HDL [Baseline, 12 weeks]

    Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.

  7. Change in LDL [Baseline, 12 weeks]

    Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.

  8. Change in triglycerides [Baseline, 12 weeks]

    Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.

  9. 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.

  10. 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.

  11. 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.

  12. Change in hand grip strength [Baseline, 12 weeks]

    Change in hand grip strength, measured by dynamometer.

  13. 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.

  14. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Manpreet Mundi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Manpreet S. Mundi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05080699
Other Study ID Numbers:
  • 20-012322
First Posted:
Oct 18, 2021
Last Update Posted:
Jul 6, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Manpreet S. Mundi, Principal Investigator, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022