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

109 Participants Needed

Trial Summary

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 data supports the effectiveness of the AHEI diet treatment for endometriosis?

Research suggests that dietary changes, including increased consumption of foods rich in omega-3, fruits, vegetables, and whole grains, may help reduce the risk and symptoms of endometriosis. Although specific studies on the AHEI diet for endometriosis are limited, these components are part of the AHEI diet and have shown potential benefits in managing the condition. ^{1 2 3 4 5}

Is the AHEI diet safe for humans?

The available studies on dietary interventions for endometriosis, including those similar to the AHEI diet, suggest that these diets are generally safe for humans. They often focus on increasing fruits, vegetables, and whole grains, which are typically considered safe and healthy dietary choices. ^{1 2 3 5 6}

How does the AHEI diet treatment for endometriosis differ from other treatments?

The AHEI diet treatment for endometriosis is unique because it focuses on improving diet quality by increasing the intake of anti-inflammatory foods like fruits, vegetables, and whole grains, which may help reduce symptoms. Unlike pharmaceutical treatments, which can have side effects, this dietary approach aims to manage symptoms through nutritional changes. ^{1 2 6 7 8}

What is the purpose of this trial?

The investigators are conducting this study to examine if a healthy diet based on the Alternative Healthy Eating Index (AHEI) influences pain symptoms, quality of life, and inflammatory markers measured in blood samples in women with endometriosis who are currently experiencing pain symptoms.

Research Team

Holly R Harris, PhD

Principal Investigator

Fred Hutchinson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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]

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

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

4. England 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. [2023]

5. Netherlands 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. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Does Nutrition Affect Endometriosis? [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

I Am the 1 in 10-What Should I Eat? A Research Review of Nutrition in Endometriosis. [2022]

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

Dietary Practices of Women with Endometriosis: A Cross-Sectional Survey. [2021]