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Enrolling by invitation NCT05080699

Evaluating Benefit of Peptide Based Diet in Obese HEN Patients

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peptamen Intense VHP, Nestlé Health Science, Switzerland.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 supplement Peptamen 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.

Primary outcome measures

  • Change in body weight [Time frame: Baseline, 3 months]
Secondary outcome measures (12)
  • Change in lean body mass [Time frame: Baseline, 12 weeks]
  • Change in systolic and diastolic blood pressure [Time frame: Baseline, 12 weeks]
  • Change in HbA1c [Time frame: Baseline, 12 weeks]
  • Change in c-peptide [Time frame: Baseline, 12 weeks]
  • Change in total cholesterol [Time frame: Baseline, 12 weeks]
  • Change in HDL [Time frame: Baseline, 12 weeks]
  • Change in LDL [Time frame: Baseline, 12 weeks]
  • Change in triglycerides [Time frame: Baseline, 12 weeks]
  • Change in percent goal calories provided with enteral nutrition [Time frame: Baseline, 12 weeks]
  • Change in percent goal proteins provided with enteral nutrition [Time frame: Baseline, 12 weeks]
  • Change in tube feeding tolerance [Time frame: Baseline, 12 weeks]
  • Change in hand grip strength [Time frame: Baseline, 12 weeks]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT05080699 · 20-012322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗