AHEI Diet for Endometriosis
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Fred Hutchinson Cancer Research Center
Disqualifiers: Postmenopausal, Pregnant, Hysterectomy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12356How 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.
12678Eligibility 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.
+8 more
Exclusion Criteria
I have a history of kidney stones, cancer (other than skin cancer), or diabetes.
I am postmenopausal.
You are currently pregnant.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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: ControlActive Control1 Intervention
Participants in this arm will not receive the dietary intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fred Hutchinson Cancer Research CenterSeattle, WA
Loading ...
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
Fred Hutchinson Cancer CenterLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Diet quality and perceived effects of dietary changes in Dutch endometriosis patients: an observational study. [2022]What is the current diet of women with endometriosis, in terms of adherence to dietary guidelines and use of diets, and what are the perceived effects of dietary modifications?
Nutritional aspects related to endometriosis. [2016]This literature review analyzed the evidence on nutritional aspects related to the pathogenesis and progression of endometriosis. Diets deficient in nutrients result in changes in lipid metabolism, oxidative stress and promote epigenetic abnormalities, that may be involved in the genesis and progression of the disease. Foods rich in omega 3 with anti-inflammatory effects, supplementation with N-acetylcysteine, vitamin D and resveratrol, in addition to the increased consumption of fruits, vegetables (preferably organic) and whole grains exert a protective effect, reducing the risk of development and possible regression of disease. Dietary re-education seems to be a promising tool in the prevention and treatment of endometriosis.
Effectiveness of Dietary Interventions in the Treatment of Endometriosis: a Systematic Review. [2023]A patients' increasing interest in dietary modifications as a possible complementary or alternative treatment of endometriosis is observed. Unfortunately, the therapeutic potential of dietary interventions is unclear and to date no guidelines to assist physicians on this topic exist. The aim of this study, therefore, was to systematically review the existing studies on the effect of dietary interventions on endometriosis. An electronic-based search was performed in MEDLINE and COCHRANE. We included human and animal studies that evaluated a dietary intervention on endometriosis-associated symptoms or other health outcomes. Studies were identified and coded using standard criteria, and the risk of bias was assessed with established tools relevant to the study design. We identified nine human and 12 animal studies. Out of the nine human studies, two were randomized controlled trials, two controlled studies, four uncontrolled before-after studies, and one qualitative study. All of them assessed a different dietary intervention, which could be classified in one of the following principle models: supplementation with selected dietary components, exclusion of selected dietary components, and complete diet modification. Most of the studies reported a positive effect on endometriosis; they were however characterized by moderate or high-risk bias possibly due to the challenges of conducting dietary intervention trials. According to the available level of evidence, we suggest an evidence-based clinical approach for physicians to use during consultations with their patients. Further well-designed randomized controlled trials are needed to accurately determine the short-term and long-term effectiveness and safety of different dietary interventions.
The effect of dietary interventions on pain and quality of life in women diagnosed with endometriosis: a prospective study with control group. [2023]What is the influence of dietary interventions, namely the low fermentable oligo-, di-, mono-saccharides, and polyols (Low FODMAP) diet and endometriosis diet, on endometriosis-related pain and quality of life (QoL) compared to a control group?
A better quality of life could be achieved by applying the endometriosis diet: a cross-sectional study in Dutch endometriosis patients. [2023]Does the endometriosis diet positively affect quality of life (QoL) in women diagnosed with endometriosis?
Does Nutrition Affect Endometriosis? [2021]Endometriosis is a hormone-related, chronic inflammation in women of childbearing age. The aetiology and pathogenesis of endometriosis are not yet fully understood. For other illnesses classed as lifestyle diseases, the link between nutrition and pathogenesis has already been researched and proven. With regard to these findings, the question continues to arise as to whether and how a specific diet and lifestyle could also influence pathogenesis and the progression of endometriosis. The aim of this review is to examine the data and determine what influence nutrition has on the development of endometriosis or on existing disease. The study results currently available do not permit a clear, scientific recommendation or indicate a detailed diet. In summary, it can be said that fish oil capsules in combination with vitamin B 12 have been associated with a positive effect on endometriosis symptoms (particularly of dysmenorrhoea). Alcohol and increased consumption of red meat and trans fats are associated with a negative effect. The results of the studies listed with regard to fruit and vegetables, dairy products, unsaturated fats, fibre, soy products and coffee are not clear. Therefore, the general recommendations for a balanced and varied diet in line with the guidelines of the Deutsche Gesellschaft für Ernährung e. V. [German Nutrition Society] apply, along with the recommendation to cut out alcohol. In order to be able to derive more concrete recommendations, we require further studies to investigate the influence of nutrition on endometriosis.
I Am the 1 in 10-What Should I Eat? A Research Review of Nutrition in Endometriosis. [2022]Endometriosis is a chronic, painful, estrogen-related inflammatory disease that affects approximately 10% of the female population. Endometriosis has a significant negative impact on quality of life. Nutrition may be involved in the development and severity of endometriosis. The purpose of this paper is to discuss in detail the nutritional recommendations for patients with endometriosis. This article discusses the importance of nutrients such as polyphenols, vitamins C, D and E, PUFAs, and iron in the development of endometriosis. Alternative diets, such as the Mediterranean, anti-inflammatory, vegetarian, low-nickel and low-FODMAP diets, have also been presented in the context of their potential beneficial effects on the course of endometriosis.
Dietary Practices of Women with Endometriosis: A Cross-Sectional Survey. [2021]Background: Endometriosis causes deleterious effects on the lives of sufferers across multiple domains impacting quality of life. Commonly utilized pharmaceutical interventions offer suboptimal efficacy in addition to potentially intolerable side effects for many women. There is some evidence for dietary therapies reducing endometriosis symptoms, but little data on dietary preferences/strategies used, and their impact, in a community setting. Methods: A cross-sectional online survey was conducted between October and December 2017 to investigate the self-management strategies employed by women with endometriosis. Participants were aged 18-45 years, living in Australia, and had a surgically confirmed diagnosis of endometriosis. Results: Four hundred eighty-four responses were included for analysis, with 76% of women reporting the use of general self-management strategies within the last 6 months. Of these, 44% of respondents reported using dietary strategies for symptom management. Reducing or eliminating gluten, reducing or eliminating dairy, and the low-fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet were the most commonly reported dietary strategies utilized. Respondents reported a 6.4/10 effectiveness score for reduction in pelvic pain with dietary changes, with no difference in pain reduction between the various diets used. Furthermore, women self-reported significant improvements in comorbidities such as gastrointestinal (GI) disturbance (39%), nausea and vomiting (15%), and fatigue (15%). Conclusions: Dietary modifications are a very common self-management strategy employed by people with endometriosis, with the greatest benefit reported on GI symptoms. Reducing or eliminating gluten, dairy, or FODMAPs or a combination of these was the most common strategy. No single diet appeared to provide greater self-reported benefits than others.