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ObesityNCT05080699

Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

A study testing Peptamen Intense VHP, Nestlé Health Science, Switzerland in people with Obesity, run by Mayo Clinic at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Peptamen Intense VHP, Nestlé Health Science, Switzerland
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
25 Mar 2023to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study

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.

Conditions
Obesity
Being tested
Peptamen Intense VHP, Nestlé Health Science, Switzerland
Keywords
Tube feeding, Obesity, Body mass
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05080699
Study groupRoleWhat they receive
Peptamen Intense in obese home enteral nutrition patients after strokeExperimentalSubjects 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.
Receives: Dietary Supplement: Peptamen Intense VHP, Nestlé Health Science, Switzerland

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Change in body weight, measured in kg

    Measured: Baseline, 3 months

Secondary outcomes (14)

  1. 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

    Measured: Baseline, 12 weeks

  2. Change in systolic and diastolic blood pressure

    Change in systolic and diastolic blood pressure, measured in mmHg

    Measured: Baseline, 12 weeks

  3. Change in HbA1c

    Change in hemoglobin A1c, measured in percentage

    Measured: Baseline, 12 weeks

  4. Change in c-peptide

    Change in c-peptide serum levels, measured in ng/mL

    Measured: Baseline, 12 weeks

  5. Change in total cholesterol

    Change in total cholesterol, measured in milligrams (mg) of cholesterol per deciliter (dL) of blood.

    Measured: Baseline, 12 weeks

  6. Change in HDL

    Change in HDL, measured in milligrams (mg) of HDL per deciliter (dL) of blood.

    Measured: Baseline, 12 weeks

  7. Change in LDL

    Change in LDL, measured in milligrams (mg) of LDL per deciliter (dL) of blood.

    Measured: Baseline, 12 weeks

  8. Change in triglycerides

    Change in triglycerides, measured in milligrams (mg) of triglycerides per deciliter (dL) of blood.

    Measured: Baseline, 12 weeks

  9. 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.

    Measured: Baseline, 12 weeks

  10. 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.

    Measured: Baseline, 12 weeks

  11. 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.

    Measured: Baseline, 12 weeks

  12. Change in hand grip strength

    Change in hand grip strength, measured by dynamometer.

    Measured: Baseline, 12 weeks

  13. 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.

    Measured: Baseline, 12 weeks

  14. 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.

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start25 Mar 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05080699
Sponsor's protocol ID
20-012322
Status last verified
Jan 2026
First submitted
4 Oct 2021
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Peptamen Intense VHP, Nestlé Health Science, Switzerland in people with Obesity, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05080699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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