Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05080699
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 25, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Peptamen Intense in obese home enteral nutrition patients after stroke
    Subjects currently enrolled in Mayo Clinic Home Enteral Nutrition (HEN) program and anticipated to require tube feedings to provide 90% or more of feeding needs will be placed on a Peptamen Intense VHP for up to 12 weeks.

Primary Outcome Measure

Change in body weight [ Time Frame: Baseline, 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic in Rochester· Rochester, MN

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