Clinical trial

Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Invitation only · Not applicable · 1 countries · Registry ID NCT05080699

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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).

Treatments and study arms

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

Change in body weightBaseline, 3 months

Change in body weight, measured in kg

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mayo Clinic in Rochester🇺🇸 Rochester, Minnesota, United States

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