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AHEI Diet for Endometriosis
N/A
Recruiting
Led By Holly Harris
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female
Aged 18-45
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial will test if a healthy diet can help ease endometriosis pain and improve quality of life.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include initial digestive discomfort as the body adjusts to new eating habits. No severe side effects are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
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I am between 18 and 45 years old.
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I have had at least one menstrual period in the last 6 months.
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I have experienced significant pain, scoring 7 or more, in the last 3 months.
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I am female.
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I am between 18 and 45 years old.
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My endometriosis was confirmed through a laparoscopy.
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I have had at least one menstrual period in the last 6 months.
Select...
I have experienced severe pain, scoring 7 or more, in the last 3 months.
Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inflammatory Markers
Pain
Protein Measurement
+5 moreTrial Design
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 Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,272 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,295 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My endometriosis was confirmed through a laparoscopy.I am between 18 and 45 years old.I have a history of kidney stones, cancer (other than skin cancer), or diabetes.I am between 18 and 45 years old.I am female.I am postmenopausal.You are currently pregnant.I have had a hysterectomy or oophorectomy.I have a chronic illness like celiac, Crohn's, ulcerative colitis, or cystic fibrosis.I have had at least one menstrual period in the last 6 months.I have experienced severe pain, scoring 7 or more, in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Endometriosis Patient Testimony for trial: Trial Name: NCT04259788 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible for individuals of advanced age to participate in this investigation?
"Those hoping to join this trial must be over 18 years old and below the age of 45."
Answered by AI
How many participants is the trial recruiting?
"Affirmative, the information found on clinicaltrials.gov confirms that this trial is currently seeking volunteers. This experiment was initially listed on May 24th 2021 and has since been edited for the last time on September 28th 2022. A total of 100 individuals are being sought out from 1 location."
Answered by AI
Are there any vacant positions in this experiment for prospective participants?
"Affirmative. The clinical trial's webpage on clinicaltrials.gov indicates that the study is currently looking for participants, which was initially posted on May 24th 2021 and most recently updated on September 28th 2022. 100 patients from 1 medical facility need to be enrolled in this investigation."
Answered by AI
Could I be eligible to participate in this clinical exploration?
"This investigation is seeking 100 individuals suffering from endometrioma, aged between 18 and 45. Participants must meet a few qualifications to be accepted; they need to have achieved a VAS pain score of no less than 7 out of 10 in the last 3 months, identify as female, be premenopausal (having had at least one cycle within 6 months), and scored below 75 on AHEI-2010."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
Washington
What site did they apply to?
Fred Hutchinson Cancer Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Out of options. I have experienced relief in endometriosis pain with healthy eating in the past.
PatientReceived 1 prior treatment
My endometriosis diagnosis was missed by several healthcare providers over the past 16 years. I’ve experienced dysmenorrhea, dyspareunia, and recently unexplained infertility. After my first IVF failed, my RE didn’t have any explanation. She recommended several options, including being evaluated for endometriosis. I was surprised to learn the severity during the surgery, and frustrated this wasn’t part of my screening earlier on. Now I want to do everything I can to spread awareness about this condition and help improve screening and treatment for it.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Fred Hutchinson Cancer Research Center: < 48 hours
Typically responds via
Email
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