Plant-Based Diet for Endometriosis

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

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 their usual diets for 12 weeks. Participants in both groups will be asked to make no changes to their exercise patterns for the study period. Changes in pain, quality of life, and inflammatory biomarkers from baseline to final will be the primary outcomes. Secondary outcomes will include changes in body weight, blood lipids, gut microbiome composition, and hormonal changes.

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.

What data supports the effectiveness of the treatment 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 their anti-inflammatory effects. However, more well-designed studies are needed to confirm the effectiveness of dietary interventions for endometriosis. ^{1 2 3 4 5}

Is a plant-based diet safe for humans?

A plant-based diet is generally considered safe for humans and can be part of a healthy lifestyle. It emphasizes fruits, vegetables, whole grains, and legumes, which are associated with various health benefits. However, it's important to ensure a balanced intake of nutrients, such as vitamin B12, which may require supplementation. ^{1 3 5 6 7}

How does a plant-based diet treatment for endometriosis differ from other treatments?

A plant-based diet treatment for endometriosis is unique because it focuses on dietary changes, emphasizing low-fat, whole foods, and vegan options, which may help reduce inflammation and improve symptoms. Unlike standard medical treatments, which often involve medication or surgery, this approach uses nutrition to potentially manage the condition. ^{1 2 3 4 8}

Research Team

Hana Kahleova, MD, PhD

Principal Investigator

Physicians Committee for Responsible Medicine

Neal Barnard, MD

Principal Investigator

Physicians Committee for Responsible Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Diet quality and perceived effects of dietary changes in Dutch endometriosis patients: an observational study. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Nutritional aspects related to endometriosis. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Diet and risk of endometriosis in a population-based case-control study. [2021]

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

Effectiveness of Dietary Interventions in the Treatment of Endometriosis: a Systematic Review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Food groups and nutrients consumption and risk of endometriosis: a systematic review and meta-analysis of observational studies. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

Influence of diet on the risk of developing endometriosis. [2018]

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

Does Nutrition Affect Endometriosis? [2021]

8. Iran pubmed.ncbi.nlm.nih.gov

Diet and The Risk of Endometriosis in Iranian Women: A Case-Control Study. [2022]