Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05080699

Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Peptamen Intense VHP, Nestlé Health Science, Switzerland

Dietary Supplement

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 outcomes

  1. Change in body weight

    Time frame: Baseline, 3 months

    Change in body weight, measured in kg

Secondary outcomes

  1. Change in lean body mass

    Time frame: 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

    Time frame: Baseline, 12 weeks

    Change in systolic and diastolic blood pressure, measured in mmHg

  3. Change in HbA1c

    Time frame: Baseline, 12 weeks

    Change in hemoglobin A1c, measured in percentage

  4. Change in c-peptide

    Time frame: Baseline, 12 weeks

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

  5. Change in total cholesterol

    Time frame: Baseline, 12 weeks

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

  6. Change in HDL

    Time frame: Baseline, 12 weeks

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

  7. Change in LDL

    Time frame: Baseline, 12 weeks

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

  8. Change in triglycerides

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, 12 weeks

    Change in hand grip strength, measured by dynamometer.

  13. Change in diabetes medications

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2021
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.