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Dietary Supplement
Peptide-Based Diet for Obesity
N/A
Waitlist Available
Led By Manpreet Mundi, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of stroke
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
Study Summary
This trial will study the effects of a high protein, low energy tube feeding formula on obese patients who are tube fed. It will assess the formula's impact on body weight, lean body mass, blood pressure, blood sugar, and lipids, as well as the patient's tolerance of the formula.
Who is the study for?
This trial is for obese individuals who are on home enteral nutrition (HEN), meaning they get most of their energy from tube feeding. They should have a stable weight over the past month, a BMI over 30, and a history of stroke. People with active cancer treatment, severe kidney disease, or less than six months to live cannot join.Check my eligibility
What is being tested?
The study is testing Peptamen Intense VHP, which is a low-energy, high-protein tube feeding formula designed by Nestlé Health Science in Switzerland. The goal is to see if it helps reduce body weight while maintaining muscle mass and improving blood pressure, sugar levels, and cholesterol in obese HEN patients.See study design
What are the potential side effects?
Possible side effects may include digestive discomfort due to the new diet composition. Since this intervention involves nutritional changes rather than medication, fewer side effects are expected compared to drug trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a stroke in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in body weight
Secondary outcome measures
Change in HDL
Change in HbA1c
Change in LDL
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Peptamen Intense in obese home enteral nutrition patients after strokeExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,039 Total Patients Enrolled
84 Trials studying Obesity
14,711 Patients Enrolled for Obesity
Manpreet Mundi, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
30 Total Patients Enrolled
2 Trials studying Obesity
30 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely reduced.I have had a stroke in the past.I am currently receiving treatment for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Peptamen Intense in obese home enteral nutrition patients after stroke
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this clinical research that volunteers can fill?
"The investigation described on clinicaltrials.gov is not currently seeking out participants, as its latest update was made in November of 2022. Nevertheless, there are 956 other trials that are actively recruiting patients at this time."
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