Weight Loss for Lipedema

(Lipedema Trial)

Overseen By Nikki Plassmeyer, MA, RDN, LD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Steroids, Anticoagulants, others

Disqualifiers: Menopause, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 5

19 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves lean and obese women with lipedema following a dietitian-guided weight loss plan. The goal is to see if losing weight can improve fat distribution, overall health, and potentially reduce pain and fat buildup in the legs.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that could affect the study results, like steroids or certain cholesterol-lowering drugs, if they can't be temporarily stopped for the study.

What data supports the effectiveness of the Mediterranean diet as a treatment for weight loss in lipedema?

Research shows that a modified Mediterranean diet can help reduce fat in the arms and legs of people with lipedema, making daily activities easier and less painful. Additionally, the Mediterranean diet has been effective in promoting weight loss and improving health in other conditions, such as obesity and metabolic syndrome, due to its anti-inflammatory and antioxidant properties. ^{1 2 3 4 5}

Is the Mediterranean diet safe for humans?

The Mediterranean diet is generally considered safe for humans and has been associated with health benefits such as improved cardiovascular health and reduced obesity. It emphasizes the consumption of vegetables, fruits, whole grains, and healthy fats like olive oil, which contribute to its anti-inflammatory and antioxidant properties. ^{2 4 5 6 7}

How does the Mediterranean diet treatment for lipedema differ from other treatments?

The Mediterranean diet treatment for lipedema is unique because it focuses on a balanced dietary pattern rich in fruits, vegetables, whole grains, and healthy fats, which may help reduce fat mass in areas typically resistant to weight loss. Unlike the ketogenic diet, which is high in fats and low in carbohydrates, the Mediterranean diet offers a more moderate approach that can improve daily physical activities and quality of life without the strict dietary restrictions of other treatments. ^{1 8 9 10 11}

Research Team

Samuel Klein, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for women with lipedema, a condition causing abnormal fat accumulation in the legs. Eligible participants include lean women (BMI between 19.5 and 26) and those with obesity (BMI between 30 and 50), without type 2 diabetes, significant organ dysfunction, or recent cancer. They shouldn't have had bariatric surgery or be on certain medications.

Inclusion Criteria

I am a woman with a BMI between 30 and 50, and have lipedema.

I have been diagnosed with Lipedema.

I am a woman with lipedema and my BMI is between 19.5 and 26.

Exclusion Criteria

I have gone through menopause naturally or due to medical reasons.

I have had weight loss surgery in the past.

My cancer has been in remission for less than 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Baseline testing including MRI, DXA scans, blood samples, and insulin sensitivity assessment

Approximately 30 hours over 2 visits

2 visits (1 inpatient overnight stay)

Diet-Induced Weight Loss

Participants undergo dietitian and/or behaviorist guided weight-loss to achieve 5-10% weight loss

4-6 months

Weekly visits (in-person or remote)

Post-Weight Loss Testing

Repeat of baseline testing to assess changes after weight loss

Approximately 30 hours over 2 visits

2 visits (1 inpatient overnight stay)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mediterranean diet
• Weight loss

Trial Overview The study investigates how diet-induced weight loss affects body composition, insulin sensitivity, and fat tissue biology in women with lipedema. It involves comprehensive testing against control groups to understand the impact of weight loss as a potential therapy for managing lipedema.

Participant Groups

Group I: Women with Obesity and Lipedema Experimental Treatment 1 Intervention

Body composition, adipose tissue biology, insulin sensitivity and immune function/inflammation assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.

Group II: Lean women with Lipedema Experimental Treatment 1 Intervention

Body composition, adipose tissue biology, insulin sensitivity assessed before and after low-calorie diet therapy to achieve 5-10% weight loss.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Lipedema Foundation

Collaborator

Trials

5

Recruited

840+

Findings from Research

The Mediterranean Diet (MedDiet) has been linked to numerous health benefits, particularly in reducing the risk of cardiovascular diseases, metabolic disorders, and cancer, as evidenced by an increase in clinical trials over the last decade.

The diet's positive effects are largely attributed to its anti-inflammatory and antioxidant properties, with strict adherence and specific components like olive oil playing crucial roles in managing obesity and waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean Diet: An Update of the Clinical Trials. Finicelli, M., Di Salle, A., Galderisi, U., et al.[2022]

A 6-month dietary intervention using the Italian Mediterranean Diet (IMD) in 80 patients with metabolic syndrome led to significant weight loss, with body weight decreasing from 102.59 kg to 92.39 kg and waist circumference reducing from 112.23 cm to 92.42 cm (p < 0.001).

The IMD also resulted in improved cardiometabolic health, with 52% of participants resolving their metabolic syndrome and significant reductions in blood pressure, fasting glucose, and harmful cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body composition changes and cardiometabolic benefits of a balanced Italian Mediterranean Diet in obese patients with metabolic syndrome. Di Daniele, N., Petramala, L., Di Renzo, L., et al.[2022]

A Mediterranean diet supplemented with dairy foods significantly reduced systolic and diastolic blood pressure in participants at risk of cardiovascular disease, indicating improved cardiovascular health.

The MedDairy diet also led to favorable changes in cholesterol levels, including higher HDL cholesterol and lower triglycerides, suggesting it may be an effective dietary approach for managing cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. Wade, AT., Davis, CR., Dyer, KA., et al.[2023]

A 20-week behavior program for 54 obese patients following a Mediterranean diet led to significant weight loss and improvements in cardiovascular risk factors and insulin sensitivity, despite a decrease in monounsaturated fatty acid intake.

The study found that while caloric restriction improved insulin sensitivity and reduced various health markers, the lipoprotein profile remained unchanged, suggesting that dietary modifications should carefully consider the balance of fats consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in nutritional pattern, insulin sensitivity and glucose tolerance during weight loss in obese patients from a Mediterranean area. Calle-Pascual, AL., Saavedra, A., Benedi, A., et al.[2011]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Effects of a Modified Mediterranean Diet on Body Composition in Lipoedema. [2021]

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

The Mediterranean Diet: An Update of the Clinical Trials. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Long term successful weight loss with a combination biphasic ketogenic Mediterranean diet and Mediterranean diet maintenance protocol. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Body composition changes and cardiometabolic benefits of a balanced Italian Mediterranean Diet in obese patients with metabolic syndrome. [2022]

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

The Nutrition Health Alliance (NutriHeAl) Study: A Randomized, Controlled, Nutritional Intervention Based on Mediterranean Diet in Greek Municipalities. [2021]

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

A Mediterranean diet supplemented with dairy foods improves markers of cardiovascular risk: results from the MedDairy randomized controlled trial. [2023]

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

Changes in nutritional pattern, insulin sensitivity and glucose tolerance during weight loss in obese patients from a Mediterranean area. [2011]

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

Ketogenic Diet: A Nutritional Therapeutic Tool for Lipedema? [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Management of Lipedema with Ketogenic Diet: 22-Month Follow-Up. [2021]

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

Effect of a ketogenic diet on pain and quality of life in patients with lipedema: The LIPODIET pilot study. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Modified Mediterranean-Ketogenic Diet and Carboxytherapy as Personalized Therapeutic Strategies in Lipedema: A Pilot Study. [2023]