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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Peptamen Intense VHP for obesity?

Research on protein-sparing modified fasts (PSMF) shows significant weight loss in obese patients, with more than half losing over 9 kg (20 lb). A revised protein-sparing diet also led to weight loss and improved metabolic health in just 21 days, suggesting that high-protein diets can be effective for obesity management. ^{1 2 3 4 5}

Is the peptide-based diet for obesity safe for humans?

Research on glucagon-like peptide-1 (GLP-1) receptor agonists, which are related to the peptide-based diet, shows they are generally safe in humans, including children and adolescents with obesity. These treatments have been approved by the USFDA for obesity and type 2 diabetes, indicating a recognized safety profile. ^{6 7 8 9 10}

How does the Peptamen Intense VHP treatment for obesity differ from other treatments?

Peptamen Intense VHP is unique because it is a peptide-based diet that may leverage the effects of specific peptides like GLP-1, which are involved in regulating appetite and satiety. Unlike traditional weight loss methods, this treatment could potentially enhance the body's natural satiety signals, helping to control food intake more effectively. ^{8 11 12 13 14}

Research Team

Manpreet Mundi, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Results of the treatment of obesity with a protein-sparing modified fast. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Revised Protein Sparing Diet in Obesity and Type 2 Diabetes Mellitus. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[The clinical efficacy of glutamine dipeptides on postoperative patients: an updated systematic review of randomized controlled trials from Europe and Asia (1997 - 2005)]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Total parenteral nutrition with glutamine dipeptide after major abdominal surgery: a randomized, double-blind, controlled study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Weight reduction utilizing a protein-sparing modified fast. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Chronic Semaglutide Treatment in Rats Leads to Daily Excessive Concentration-Dependent Sucrose Intake. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Colonic Delivery of Nutrients for Sustained and Prolonged Release of Gut Peptides: A Novel Strategy for Appetite Management. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 in the pathogenesis of obesity. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The potential use of parenteral dipeptides in clinical nutrition. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Glucagon-Like Peptide-1 Receptor Agonists in Children and Adolescents with Obesity: A Meta-Analysis. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Milk-derived peptide Val-Pro-Pro (VPP) inhibits obesity-induced adipose inflammation via an angiotensin-converting enzyme (ACE) dependent cascade. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of an Amino Acid Mix on the Secretion of Gastrointestinal Peptides, Glucometabolic Homeostasis, and Appetite in Obese Adolescents Administered with a Fixed-Dose or ad Libitum Meal. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Anti-obesity effects of Rapha diet® preparation in mice fed a high-fat diet. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Emerging hormonal-based combination pharmacotherapies for the treatment of metabolic diseases. [2022]