AHEI Diet for Endometriosis

Overseen By Holly Harris

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Postmenopausal, Pregnant, Hysterectomy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Alternative Healthy Eating Index (AHEI), a healthy diet, might reduce pain and improve life quality for women with endometriosis. This condition occurs when tissue similar to the uterine lining grows outside the uterus, causing pain. Participants will follow a specific diet plan for 12 weeks to determine if it can lessen their pain and improve certain blood health markers. Women diagnosed with endometriosis through laparoscopy and currently experiencing significant pain might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new dietary recommendations for managing endometriosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the AHEI diet is safe for women with endometriosis?

Research suggests that the Alternative Healthy Eating Index (AHEI) diet may benefit women with endometriosis. Studies have found that women who follow the AHEI diet are less likely to develop endometriosis. This diet emphasizes healthy eating habits, which can reduce pain and improve quality of life.

The AHEI diet is generally safe, as it promotes consuming more fruits, vegetables, whole grains, and healthy fats—common components of a balanced diet. Studies have not reported any serious side effects from following the AHEI diet. However, with any dietary change, monitoring for new or unusual symptoms and consulting a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AHEI diet for endometriosis is unique because it focuses on nutritional therapy rather than medication or surgery, which are common treatments for this condition. Unlike hormone therapies or pain management drugs that can have significant side effects, the AHEI diet emphasizes a balanced intake of healthy foods to potentially alleviate symptoms. Researchers are excited about this approach because it could offer a natural, holistic way to manage endometriosis with fewer side effects and promote overall well-being. Moreover, it empowers individuals to take an active role in their health through dietary choices.

What evidence suggests that the AHEI diet is effective for endometriosis?

Research shows that the Alternative Healthy Eating Index (AHEI) diet might help women with endometriosis. In this trial, participants in the intervention arm will follow the AHEI diet, which studies have found to be associated with less pain, a better quality of life, and reduced inflammation in the body. Early findings suggest that this diet can help manage pain and other symptoms in women with endometriosis. Overall, following the AHEI diet may be a promising way to lessen the impact of endometriosis symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Holly R Harris, PhD

Principal Investigator

Fred Hutchinson Cancer Center

Are You a Good Fit for This Trial?

This trial is for premenopausal women aged 18-45 with laparoscopically confirmed endometriosis and significant pain (VAS score of at least 7 out of 10). Participants should have a poor diet as indicated by an AHEI-2010 score below 75. Women who are pregnant, postmenopausal, or have certain chronic illnesses affecting nutrient absorption cannot join.

Inclusion Criteria

I have experienced significant pain, scoring 7 or more, in the last 3 months.

I am female.

I have had at least one menstrual period in the last 6 months.

Exclusion Criteria

I have a history of kidney stones, cancer (other than skin cancer), or diabetes.

I am postmenopausal.

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary counseling and follow the AHEI diet for 12 weeks, with meals and snacks provided initially.

12 weeks

In-person dietary counseling

Follow-up

Participants are monitored for changes in pain symptoms, quality of life, and inflammatory markers after the dietary intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AHEI diet

Trial Overview The study tests whether following the Alternative Healthy Eating Index (AHEI) diet can reduce pain and improve quality of life in women with endometriosis. It also looks at changes in inflammatory markers from blood samples to assess the diet's impact on inflammation.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period and discontinue any vitamin or supplement intake during this time. During the first 4 weeks 2 meals and 1 snack/day will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.

Group II: Control Active Control 1 Intervention

Participants in this arm will not receive the dietary intervention.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

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]

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]

Women with endometriosis who followed the endometriosis diet reported significantly better quality of life (QoL) across all six domains compared to those who did not adhere to the diet, based on a study of 211 participants.

Strict adherence to the diet led to even higher QoL scores than less strict adherence, suggesting that the diet may have a positive impact on the well-being of women with endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A better quality of life could be achieved by applying the endometriosis diet: a cross-sectional study in Dutch endometriosis patients. van Haaps, A., Wijbers, J., Schreurs, A., et al.[2023]

After 6 months of following either the Low FODMAP diet or the endometriosis diet, women with endometriosis reported significant reductions in pain and improvements in quality of life compared to their baseline measurements.

Participants on these diets experienced less bloating and better quality of life scores in three out of eleven domains compared to a control group, suggesting dietary interventions can be beneficial for managing endometriosis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary interventions on pain and quality of life in women diagnosed with endometriosis: a prospective study with control group. van Haaps, AP., Wijbers, JV., Schreurs, AMF., et al.[2023]

A survey of 484 women with endometriosis revealed that 44% used dietary strategies for symptom management, with common approaches including reducing gluten, dairy, and following a low-FODMAP diet.

Participants reported an average effectiveness score of 6.4/10 for dietary changes in reducing pelvic pain, and significant improvements in gastrointestinal disturbances, nausea, and fatigue, indicating that dietary modifications can be a valuable self-management strategy for endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Practices of Women with Endometriosis: A Cross-Sectional Survey. Armour, M., Middleton, A., Lim, S., 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]

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]

Nutrition plays a significant role in the development and severity of endometriosis, with specific nutrients like polyphenols, vitamins C, D, E, PUFAs, and iron being highlighted for their potential impact.

Various dietary approaches, including the Mediterranean, anti-inflammatory, vegetarian, low-nickel, and low-FODMAP diets, may offer beneficial effects in managing endometriosis symptoms and improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I Am the 1 in 10-What Should I Eat? A Research Review of Nutrition in Endometriosis. Piecuch, M., Garbicz, J., Waliczek, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102961/

Alternative healthy eating index may predict a reduced odd ... Higher adherence to the AHEI was associated with a lower odds of endometriosis as shown in crude model (OR: 0.06, 95%CI: 0.02, 0.15, P for trend ...

2. researchgate.net researchgate.net/publication/392065789_Alternative_healthy_eating_index_may_predict_a_reduced_odd_of_endometriosis_results_from_a_case-control_study

Alternative healthy eating index may predict a reduced odd ... (PDF) Alternative healthy eating index may predict a reduced odd of endometriosis: results from a case-control study.

3. grantome.com grantome.com/grant/NIH/R01-NR017951-03

An AHEI Dietary Intervention to Reduce Pain in Women ... The goal of this study is to evaluate the effects of a 12-week dietary intervention among women with laparoscopically-confirmed endometriosis who had a pain ...

4. trialx.com trialx.com/clinical-trials/listings/270102/an-ahei-dietary-intervention-to-reduce-pain-in-women-with-endometriosis/

An AHEI Dietary Intervention to Reduce Pain in Women ... A healthy diet based on the Alternative Healthy Eating Index (AHEI) influences pain symptoms, quality of life, and inflammatory markers measured in blood ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417264/

Effectiveness of Medical Nutrition Therapy in the Management ... Alternative healthy eating index may predict a reduced odd of endometriosis: results from a case-control study. BMC Womens Health. 2025;25 ...

6. link.springer.com link.springer.com/article/10.1007/s43032-020-00418-w

Effectiveness of Dietary Interventions in the Treatment ... Most of the studies reported a positive effect on endometriosis; they were however characterized by moderate or high-risk bias.