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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in body weight
Change in body weight, measured in kg
Time frame: Baseline, 3 months
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
Time frame: Baseline, 12 weeks
Change in systolic and diastolic blood pressure
Change in systolic and diastolic blood pressure, measured in mmHg
Time frame: Baseline, 12 weeks
Change in HbA1c
Change in hemoglobin A1c, measured in percentage
Time frame: Baseline, 12 weeks
Change in c-peptide
Change in c-peptide serum levels, measured in ng/mL
Time frame: Baseline, 12 weeks
Change in total cholesterol
Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.
Time frame: Baseline, 12 weeks
Change in HDL
Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.
Time frame: Baseline, 12 weeks
Change in LDL
Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.
Time frame: Baseline, 12 weeks
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Change in triglycerides
Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
Change in hand grip strength
Change in hand grip strength, measured by dynamometer.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks