NCT05080699

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
18mo left

Started Mar 2023

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2023Dec 2027

First Submitted

Initial submission to the registry

October 4, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 25, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4.7 years

First QC Date

October 4, 2021

Last Update Submit

January 22, 2026

Conditions

Obesity

Keywords

Tube feedingObesityBody mass

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    Change in body weight, measured in kg

    Baseline, 3 months

Secondary Outcomes (14)

  • Change in lean body mass

    Baseline, 12 weeks

  • Change in systolic and diastolic blood pressure

    Baseline, 12 weeks

  • Change in HbA1c

    Baseline, 12 weeks

  • Change in c-peptide

    Baseline, 12 weeks

  • Change in total cholesterol

    Baseline, 12 weeks

  • +9 more secondary outcomes

Study Arms (1)

Peptamen Intense in obese home enteral nutrition patients after stroke

EXPERIMENTAL

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.

Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland

Interventions

Peptamen Intense VHP, Nestlé Health Science, SwitzerlandDIETARY_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.

Peptamen Intense in obese home enteral nutrition patients after stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosis of cancer undergoing active treatment (chemotherapy, radiation, immunotherapy).
  • Life expectancy of less than 6 months.
  • Stage IV or higher kidney disease (GFR \< 30).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manpreet Mundi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 18, 2021

Study Start

March 25, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)