Plant-Based Diet for Endometriosis

Recruiting at 2 trial locations

Overseen By Macy Sutton, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Physicians Committee for Responsible Medicine

Disqualifiers: BMI ≥ 40, Smoking, Alcohol abuse, Unstable illness, Pregnancy, Fibroids, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-fat, plant-based diet can reduce pain and improve the quality of life for women with endometriosis. Participants will either adopt this diet or maintain their usual eating habits for 12 weeks, with both groups taking a vitamin B12 supplement. Researchers will track changes in pain levels, quality of life, and inflammation, along with other health markers such as weight and blood fats. Women diagnosed with endometriosis who can commit to a plant-based diet for 12 weeks may be suitable for this study. As an unphased study, this trial provides a unique opportunity to contribute to understanding how dietary changes might improve endometriosis symptoms.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it requires that your health condition and medications have been stable for the past 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that plant-based diets can be safe and beneficial for people with endometriosis. A study in the UK found that women on a gluten-free diet, similar to a plant-based diet, experienced a 50% reduction in pain over three months. Another study suggests that consuming a lot of vegetables may help reduce endometriosis symptoms.

Plant-based diets are generally easy to follow and can lead to better health compared to diets that include both plants and animal products. This type of diet often improves overall health, indicating its safety.

In this study, participants on the plant-based diet will take a vitamin B12 supplement, as B12 is typically found in animal products. The supplement ensures participants receive necessary nutrients without side effects.

Overall, based on existing studies, a plant-based diet is considered safe for most people, including those with endometriosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for endometriosis, which often include hormonal therapies and pain management medications, the plant-based diet intervention offers a dietary approach that aims to manage the condition naturally. This treatment is unique because it involves adopting a low-fat, plant-based diet, which is known for its anti-inflammatory properties and potential to reduce endometriosis symptoms. Additionally, this approach includes a vitamin B12 supplement to ensure nutritional balance, as plant-based diets can sometimes lack this essential nutrient. Researchers are excited about this treatment because it provides a non-invasive, holistic alternative that could improve quality of life without the side effects typically associated with traditional medications.

What evidence suggests that a plant-based diet might be an effective treatment for endometriosis?

Research has shown that a plant-based diet might help manage endometriosis. This trial will compare a Plant-based Intervention Group with a Control Group. A study in the UK found that women with endometriosis who followed a gluten-free diet for three months experienced a 50% reduction in pain. Although this study focused on gluten-free diets, it suggests that dietary changes can affect pain levels. Plant-based diets, which include fruits, vegetables, whole grains, and omega-3 rich foods, are thought to lower the risk and slow the progression of endometriosis. Additionally, eating more fruit fiber has been linked to a lower risk of developing the condition. These findings suggest that a plant-based diet could benefit those with endometriosis. ^{3 6 7 8 9}

Who Is on the Research Team?

Hana Kahleova, MD, PhD

Principal Investigator

Physicians Committee for Responsible Medicine

Neal Barnard, MD

Principal Investigator

Physicians Committee for Responsible Medicine

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 with endometriosis confirmed by surgery, imaging, or clinical diagnosis. Participants should be in stable health and not have had any changes to their medications in the past three months. They must have a certain level of pelvic pain and be willing to potentially switch to a plant-based diet for 12 weeks.

Inclusion Criteria

I have been diagnosed with endometriosis.

You are willing and able to eat only plant-based foods for 12 weeks.

I am open to changing my diet or keeping it the same as part of a study for 12 weeks.

Exclusion Criteria

I do not have any unstable medical or mental health conditions.

You have a condition related to eating that requires medical attention.

I have fibroids, ovarian cysts, or pelvic inflammatory disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a low-fat, plant-based diet or maintain their usual diet for 12 weeks

12 weeks

Baseline and 12-week visits (in-person or virtual)

Follow-up

Participants are monitored for changes in pain, quality of life, and inflammatory biomarkers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Plant-based Intervention Group

Trial Overview The study compares the effects of a low-fat plant-based diet versus usual diets over 12 weeks on women with endometriosis. It measures changes in pain, quality of life, inflammatory markers, body weight, blood lipids, gut microbiome composition, and hormonal levels without altering exercise habits.

How Is the Trial Designed?

Group I: Plant-based Intervention Group Experimental Treatment 1 Intervention

Intervention group participants will adopt a low-fat, plant-based diet for 12 weeks. Participants will be provided with a commercially available supplement containing 100 micrograms of vitamin B12 and asked to take it daily during the study. Alcoholic beverages will be limited to 1 per day. Participants will be asked to keep their physical activity level constant.

Group II: Control Group Active Control 1 Intervention

Control group participants will be asked to maintain their usual diet for the duration of the 12-week study period. Participants will be provided with a commercially available supplement containing 100 micrograms of vitamin B12 and asked to take it daily during the study. Alcoholic beverages will be limited to 1 per day. Participants will be asked to keep their physical activity level constant. At the conclusion of the 12 weeks, control group participants will be offered instruction in the plant-based diet.

Who Is Running the Clinical Trial?

Physicians Committee for Responsible Medicine

Lead Sponsor

Trials

30

Recruited

2,600+

Published Research Related to This Trial

A case-control study involving 207 women with endometriosis and 206 without found that higher intake of green vegetables, red meat, dairy products, fresh fruit, and grain legumes is associated with a lower risk of developing endometriosis.

Specifically, the study identified significant odds ratios for these foods, indicating that dietary choices may play a protective role against endometriosis in Iranian women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and The Risk of Endometriosis in Iranian Women: A Case-Control Study. Ashrafi, M., Jahangiri, N., Jahanian Sadatmahalleh, SH., et al.[2022]

Fish oil capsules combined with vitamin B12 may help alleviate symptoms of endometriosis, particularly painful menstruation (dysmenorrhea).

High consumption of alcohol, red meat, and trans fats is linked to worsening endometriosis symptoms, while the effects of fruits, vegetables, dairy, unsaturated fats, fiber, soy, and coffee remain unclear, highlighting the need for further research on dietary influences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Nutrition Affect Endometriosis? Helbig, M., Vesper, AS., Beyer, I., et al.[2021]

In a study of 157 women with endometriosis, participants reported making various dietary changes, with 46.5% following specific diets and 56.1% using dietary supplements, but overall, their diet quality was lower than that of a healthy reference group.

While dietary adjustments did not correlate with improved quality of life, many participants (71.3%) felt that these changes, particularly the removal of gluten, dairy, or soy, helped reduce pain-related symptoms of endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet quality and perceived effects of dietary changes in Dutch endometriosis patients: an observational study. Krabbenborg, I., de Roos, N., van der Grinten, P., et al.[2022]

A systematic review identified 21 studies (9 human and 12 animal) on dietary interventions for endometriosis, with most reporting positive effects on symptoms, although many had moderate to high risk of bias.

The study highlights the need for more rigorous randomized controlled trials to better understand the effectiveness and safety of dietary modifications as a treatment for endometriosis, as current evidence is inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Dietary Interventions in the Treatment of Endometriosis: a Systematic Review. Nirgianakis, K., Egger, K., Kalaitzopoulos, DR., et al.[2023]

Nutritional deficiencies can lead to changes in lipid metabolism and oxidative stress, which may contribute to the development and progression of endometriosis.

Diets rich in omega-3 fatty acids, along with supplements like N-acetylcysteine, vitamin D, and resveratrol, as well as increased intake of fruits, vegetables, and whole grains, may help reduce the risk of endometriosis and support its regression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional aspects related to endometriosis. Halpern, G., Schor, E., Kopelman, A.[2016]

Higher total dairy intake is associated with a decreased risk of endometriosis, with a relative risk of 0.90, indicating that consuming dairy may be protective against this condition.

Conversely, increased consumption of red meat, trans fatty acids, and saturated fatty acids is linked to a higher risk of endometriosis, with relative risks of 1.17, 1.12, and 1.06 respectively, suggesting that certain dietary fats may contribute to the development of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food groups and nutrients consumption and risk of endometriosis: a systematic review and meta-analysis of observational studies. Arab, A., Karimi, E., Vingrys, K., et al.[2022]

In a study of 284 women with endometriosis and 660 controls, higher total fat consumption was linked to a decreased risk of developing endometriosis, suggesting that dietary fat may play a protective role.

Conversely, increased intake of β-carotene and higher fruit consumption were associated with a higher risk of endometriosis, indicating that certain dietary components may contribute to the disease's development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and risk of endometriosis in a population-based case-control study. Trabert, B., Peters, U., De Roos, AJ., et al.[2021]

Dietary factors may play a significant role in the development of endometriosis, with certain foods like fruits, vegetables, fish oils, and dairy rich in calcium and vitamin D potentially lowering the risk of the disease.

Conversely, high consumption of trans-unsaturated fatty acids, fats, red meat, and alcohol may increase the risk of developing endometriosis, highlighting the need for further research to clarify these dietary influences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of diet on the risk of developing endometriosis. Jurkiewicz-Przondziono, J., Lemm, M., Kwiatkowska-Pamuła, A., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-endometriosis-2-2022-9b092

Plant-Based Diet for Endometriosis Research suggests that diets rich in omega-3 fatty acids, fruits, vegetables, and whole grains may help reduce the risk and progression of endometriosis due to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12299565/

The Role of Plant-Based Diets and Personalized Nutrition in ... A UK-based study found that women with endometriosis who followed a gluten-free diet for three months experienced a 50% reduction in pain [89].

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9259892/

Endometriosis and the effects of dietary interventions Many women experience that changing their diet helps to suppress pain symptoms. But it is not clear why changing the diet is effective.

4. healio.com healio.com/news/womens-health-ob-gyn/20230306/plant-based-diet-may-aid-in-preventing-treating-endometriosis

Plant-based diet may aid in preventing, treating ... A plant-based diet and vitamin D possibly beneficial in preventing and treating the disease, according to a review published in Frontiers in Nutrition.

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2023.1089891/full

Nutrition in the prevention and treatment of endometriosis Increased fruit fiber has been associated with a reduced risk of endometriosis in two independent studies (34, 42). Plant-based foods contain increased amounts ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322004963

What Role Do Plant-Based Diets Play in Supporting the ... A well-balanced and adequately planned plant-based diet has been shown to be superior in comparison to an omnivore diet in various health outcomes (1, 2, 6, 8., ...

7. news-medical.net news-medical.net/news/20251022/Mediterranean-diet-linked-to-dramatically-lower-odds-of-endometriosis.aspx

Mediterranean diet linked to dramatically lower odds of ... A new case–control study found that women with stronger adherence to the Mediterranean diet had dramatically lower odds of endometriosis.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05175248

NCT05175248 | Nutritional Intervention for Endometriosis In a 12-week parallel study, women with a verified diagnosis of endometriosis will be randomly assigned to follow a low-fat plant-based diet or to stay on ...

9. mdpi.com mdpi.com/2304-8158/14/12/2087

Diet and Endometriosis: An Umbrella Review A higher intake of vegetables and dairy products may reduce the risk and/or symptoms of endometriosis, while a high intake of caffeine and butter may increase ...