Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05080699
• Other study ID #: 20-012322
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 25, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Change in body weight, measured in kg	Baseline, 3 months
Secondary	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
Secondary	Change in systolic and diastolic blood pressure	Change in systolic and diastolic blood pressure, measured in mmHg	Baseline, 12 weeks
Secondary	Change in HbA1c	Change in hemoglobin A1c, measured in percentage	Baseline, 12 weeks
Secondary	Change in c-peptide	Change in c-peptide serum levels, measured in ng/mL	Baseline, 12 weeks
Secondary	Change in total cholesterol	Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.	Baseline, 12 weeks
Secondary	Change in HDL	Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.	Baseline, 12 weeks
Secondary	Change in LDL	Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.	Baseline, 12 weeks
Secondary	Change in triglycerides	Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.	Baseline, 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in hand grip strength	Change in hand grip strength, measured by dynamometer.	Baseline, 12 weeks
Secondary	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
Secondary	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