Evaluating Benefit of Peptide Based Diet in Obese HEN Patients
- Conditions
- Obesity
- Registration Number
- NCT05080699
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in body weight Baseline, 3 months Change in body weight, measured in kg
- Secondary Outcome Measures
Name Time Method Change in LDL Baseline, 12 weeks Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.
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
Change in systolic and diastolic blood pressure Baseline, 12 weeks Change in systolic and diastolic blood pressure, measured in mmHg
Change in HbA1c Baseline, 12 weeks Change in hemoglobin A1c, measured in percentage
Change in total cholesterol Baseline, 12 weeks Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Change in c-peptide Baseline, 12 weeks Change in c-peptide serum levels, measured in ng/mL
Change in HDL Baseline, 12 weeks Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.
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.
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.
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.
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.
Change in hand grip strength Baseline, 12 weeks Change in hand grip strength, measured by dynamometer.
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.
Change in triglycerides Baseline, 12 weeks Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States