Peptide-Based Diet for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cancer, Life expectancy < 6 months, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special diet formula to help obese individuals who use tube feeding lose weight and improve health markers like blood pressure and blood sugar. The study employs a high-protein, low-energy formula called Peptamen Intense VHP, designed for those who have had a stroke and rely on tube feeding for most of their nutrition. Ideal participants are patients who receive most of their nutrition from tube feeding, have a BMI over 30, and have had a stroke but have maintained stable weight recently. As an unphased trial, this study provides a unique opportunity to explore new dietary approaches for better health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diet is safe for obese patients?

Research shows that Peptamen Intense VHP is generally well-tolerated by patients. This special liquid food is high in protein, low in carbohydrates, and contains omega-3s, which are healthy fats. The formula helps manage blood sugar and reduce inflammation, which involves swelling and redness in the body. It provides ample protein without excessive calories, crucial for very sick individuals needing tube feeding.

Sources mention no specific safety concerns, which is reassuring. The formula is designed to meet the needs of those requiring a high-protein diet and is intended to be gentle on the stomach. Studies suggest it is safe for the target patient group, including obese patients who rely on tube feeding for most of their nutrition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Peptamen Intense VHP is unique because it offers a peptide-based diet specifically designed for obese patients who need tube feeding, especially after a stroke. Unlike standard nutritional formulas, Peptamen Intense VHP is packed with a high protein content, which can be crucial for healing and maintaining muscle mass. Researchers are excited about this treatment because it may optimize nutrition delivery and improve recovery outcomes for patients who rely on home enteral nutrition, potentially offering a more targeted approach than conventional options.

What evidence suggests that Peptamen Intense VHP might be an effective treatment for obesity?

Research shows that Peptamen Intense VHP, a high-protein formula for tube feeding, can benefit obese patients. Studies have found that 37% of its calories come from protein, which helps maintain muscle strength and supports overall health. Additionally, Peptamen Intense VHP is linked to fewer blood sugar spikes, aiding in blood sugar management. Most patients tolerate this formula well, experiencing no issues. Overall, these findings suggest that Peptamen Intense VHP may be a good option for managing obesity in patients requiring tube feeding. ^{4 6 7 8 9}

Who Is on the Research Team?

Manpreet Mundi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI > 30

I have had a stroke in the past.

HEN patient receiving at least 90% of energy needs from enteral nutrition

Exclusion Criteria

My kidney function is severely reduced.

Life expectancy of less than 6 months

I am currently receiving treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Peptamen Intense VHP formula for up to 12 weeks to assess effects on body weight and health outcomes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peptamen Intense VHP

Trial Overview 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.

How Is the Trial Designed?

Group I: Peptamen Intense in obese home enteral nutrition patients after stroke Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Chronic administration of the GLP-1 receptor agonist semaglutide (SEMA) in rats led to reduced food intake and body weight, indicating its efficacy in weight management, similar to effects seen in humans with obesity.

Interestingly, while SEMA-treated rats consumed more sucrose at lower concentrations compared to controls, their overall energy intake became similar to that of control rats, suggesting that SEMA's impact on food intake may vary depending on the type of caloric source available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Semaglutide Treatment in Rats Leads to Daily Excessive Concentration-Dependent Sucrose Intake. Cawthon, CR., Blonde, GD., Nisi, AV., et al.[2023]

GLP-1 receptor agonists, such as exenatide and liraglutide, have been shown to safely and effectively reduce body weight and BMI in children and adolescents with obesity, based on a meta-analysis of 9 studies involving 574 participants.

While these medications improved glycemic control in children with insulin resistance and led to a modest decrease in systolic blood pressure, they also increased the risk of nausea, highlighting a common gastrointestinal side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Glucagon-Like Peptide-1 Receptor Agonists in Children and Adolescents with Obesity: A Meta-Analysis. Ryan, PM., Seltzer, S., Hayward, NE., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05080699

Evaluating Benefit of Peptide Based Diet in Obese HEN ... 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. Official Title.

2. nestlehealthscience.de nestlehealthscience.de/sites/default/files/2023-08/Peptamen-Has-the-Proof_2020.pdf

PEPTAMEN® has the Proof In ICUs with low baseline nutritional adequacy, the PEPuP protocol results in a statistically significant increase in protein (p=0.005).

3. nestlemedicalhub.com nestlemedicalhub.com/products/peptamen-intense-vhp

PEPTAMEN® Intense VHP The evidence-based, well-tolerated, very high protein, GI formula · Highest percentage of calories from protein (37%) of any complete tube-feeding formula to ...

4. ce.mayo.edu ce.mayo.edu/sites/default/files/Peptamen%20Rice%20Divine%20BG%20Control%20PowerPack.pdf

PEPTAMEN® Intense VHP Formula Use of a very high protein, enzymatically hydrolyzed. 100% whey, lower CHO EN formula was related to decreased hyperglycemic events and insulin.

5. researchgate.net researchgate.net/figure/Composition-Control-and-Experimental-Enteral-Nutrition-Formulas_tbl1_327924839

Composition Control and Experimental Enteral Nutrition ... Malnutrition is frequently seen among patients in the intensive care unit. Evidence shows that optimal nutritional support can lead to better clinical outcomes.

6. nestlehealthscience.ca nestlehealthscience.ca/en/brands/peptamen/peptamen-intense-hp-hcp

PEPTAMEN® INTENSE - Nestlé Health Science With 37% of calories from protein, Peptamen INTENSE High Protein is formulated to help meet protein needs of patients with elevated requirements.

7. medline.com medline.com/product/Peptamen-Intense-VHP-PeptideBased-Complete-Nutrition/Z05-PF137062

Peptamen Intense VHP Peptide-Based Complete Nutrition For feeding critically ill obese patients; Provides a high level of protein in a 1k calorie/mL formulation; Lessens the risk of overfeeding total energy ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7379263/

Dietary Management of Blood Glucose in Medical Critically Ill ... The experimental formula contained high‐whey peptides (37%) and low carbohydrates (29%) (Peptamen Intense VHP, Nestlé Health Science, Bridgewater, NJ). The ...

9. peptamen.com peptamen.com/product/peptamen-intense-vhp

Peptamen® Intense VHP Product Info Peptamen® Intense VHP is a high-protein, low-carb enteral nutrition formula with omega-3 to help manage inflammatory response and blood glucose levels.