Obesity
Conditions
Keywords
Tube feeding, Obesity, Body mass
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.
Interventions
DIETARY_SUPPLEMENTPeptamen 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline, 3 months | Change in body weight, measured in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline, 12 weeks | Change in hemoglobin A1c, measured in percentage |
| Change in c-peptide | Baseline, 12 weeks | Change in c-peptide serum levels, measured in ng/mL |
| Change in total cholesterol | Baseline, 12 weeks | Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood. |
| Change in HDL | Baseline, 12 weeks | Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood. |
| 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 triglycerides | Baseline, 12 weeks | Change in triglycerides, measured in milligrams (mg) of triglycerides 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 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 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 systolic and diastolic blood pressure | Baseline, 12 weeks | Change in systolic and diastolic blood pressure, measured in mmHg |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORManpreet Mundi, MD
Mayo Clinic
Outcome results
None listed