Meal Study for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Statins, β-blockers, TZDs, others

Disqualifiers: Diabetes, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how upper body fat reacts to a meal by studying its cellular activity, focusing on the release of exosomes, which are tiny particles involved in cell communication. Researchers will compare this process between individuals with normal weight and those with obesity. The trial includes two groups: one with normal weight and one with obesity, to observe how their bodies handle a mixed meal challenge. Suitable participants are premenopausal women with obesity (BMI between 29.0-35.0) who are not on certain medications or have specific health conditions. As an unphased trial, this study offers participants the chance to contribute to the scientific understanding of obesity and metabolism.

Will I have to stop taking my current medications?

If you are taking medications that affect blood flow or fat metabolism, like statins or high-dose fish oil supplements, you will need to stop taking them to participate in this trial.

What prior data suggests that this method is safe for participants?

Research has shown that tiny particles called exosomes are released from fat tissue and have been studied in various contexts, including obesity. Exosomes are small packages sent out by cells that carry important messages to other parts of the body. In past studies, exosomes from fat tissue have affected inflammation and energy processing in people with obesity.

While specific safety information for humans is not yet available, these studies suggest that exosomes play a role in managing obesity. This research is ongoing, but some studies with mice have shown benefits like lower blood sugar and fat levels. It is important to remember that these findings are in the early stages, and more research is needed to fully understand their safety and effects in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Upper Body Subcutaneous Exosome Release treatment for obesity because it represents a novel approach compared to traditional treatments like diet, exercise, and medication. This treatment leverages exosomes, tiny particles released by cells, which are thought to play a role in cell communication and metabolism. By focusing on the release of these exosomes in subcutaneous (under the skin) fat, researchers aim to alter metabolic processes in a way that could lead to weight loss. This innovative method could offer a new, less invasive option for managing obesity, potentially bypassing the side effects associated with current drug therapies.

What evidence suggests that this method is effective for studying obesity?

Research has shown that exosomes, tiny particles released from fat tissues, influence how obesity affects the body. Studies suggest these exosomes can alter how the body processes fats in the blood. Some findings indicate that exosomes from certain fat cells might help reduce body fat and inflammation while increasing the body's heat production. This trial will examine the release of exosomes in two groups: a normal weight group and an obesity group. Overall, early research is promising for using exosomes to understand and potentially treat obesity by affecting fat storage and energy use. ^{1 3 6 7 8}

Who Is on the Research Team?

Kelli A Lytle

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who are either of normal weight or have obesity. It aims to study how their upper body fat tissue reacts to a meal by examining blood from a specific vein near the stomach.

Inclusion Criteria

I am a woman and have not gone through menopause.

Exclusion Criteria

I am taking medication that affects blood flow or fat metabolism.

Allergy to lidocaine

I have a history of heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Meal Challenge

Participants undergo a mixed meal challenge to assess upper body subcutaneous adipose tissue response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the meal challenge

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• Upper Body Subcutaneous Exosome Release

Trial Overview The intervention being studied is the body's response to a mixed meal, focusing on exosome release in the blood. Researchers will compare this between people with and without obesity using samples from a targeted vein.

How Is the Trial Designed?

Group I: Obesity group Experimental Treatment 1 Intervention

5 male and 5 female volunteers with obesity (BMI 29.0-35.0 kg/m2)

Group II: Normal weight group Experimental Treatment 1 Intervention

5 male and 5 female volunteers in normal weight range

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11803032/

Omics approach to reveal the effects of obesity on the protein ... Our data provide scientific evidence to suggest SAT-Exos contribute to the changes in plasma lipid profiles under obesity conditions. Supplementary Information.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2090123225003698

Exosomal miR-1246 of adipose stem cells attenuates ... iADSC-EXO alleviates obesity by reducing fat mass, inflammation and enhancing thermogenesis. Impact and underlying molecular mechanism of iADSC-EXO were ...

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1162992/full

Adipose tissue-derived exosomes contribute to obesity- ... Our results demonstrate that obesity alters the effects of adipose tissue-derived exosomes in the liver, potentially becoming a risk factor in the development ...

4. mdpi.com mdpi.com/2673-4540/5/7/52

Exosome-Derived microRNAs: Bridging the Gap Between ... This review provides a comprehensive overview of the interplay between exosome-derived miRNA, obesity, and type 2 diabetes and summarizes the latest findings ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8531905/

The impact of obesity on adipocyte-derived extracellular vesicles This article critically reviews the current findings on the impact of obesity on the exosomal cargo contents that induce the pathophysiological changes.

6. mdpi.com mdpi.com/2218-273X/15/2/231

Obesity and Adipose-Derived Extracellular Vesicles EVs' release from immune cells appear to modulate inflammation and metabolic responses in obesity [3,4] being the macrophages the cells of the immune system ...

7. link.springer.com link.springer.com/article/10.1007/s12672-023-00704-4

Adipocyte-derived extracellular vesicles Obese patients have shown impacts of obesity on the exosomal cargo of adipocyte-derived exosomes. A clinical investigation demonstrates that ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10775587/

Extracellular vesicle therapy for obesity-induced NAFLD We highlight therapeutic approaches using exosomes in the clinical treatment of NAFLD, which provide valuable insights into targeting NAFLD in the clinical ...