EndometriosisNCT07090096
A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
A study testing A whole food plant based diet in people with Endometriosis, run by University of California, San Diego at 1 site in United States.
Trial summary
This randomized, controlled study will investigate the efficacy of a dietary intervention for women with endometriosis. Participants will be randomly assigned to follow a whole food plant-based (intervention) diet or stay on their usual (control) diet for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- A whole food plant based diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study visits, procedures, requirements, and availability for the duration of the study
- Women with a surgical, imaging, or clinical diagnosis of endometriosis
- Age 18-45 years
- Stable health condition and medications for the past 3 months
- Modified Biberoglu and Behrman (B\&B) pelvic pain score of at least 5/9
- Willing to be randomly assigned to either an active or a control group
- Agreement to adhere to Lifestyle Considerations throughout the study duration
Who cannot join
- Smoking or drug abuse during the past six months
- Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- Already following a WFPB diet
- Pregnant or breastfeeding, or plans of pregnancy within the study period
- Hysterectomy or ovariectomy
- Fibroids, ovarian cysts, pelvic inflammatory disease
- Endocrine inflammatory conditions, such as Cushing's syndrome, Hashimoto's thyroiditis, Graves' disease, type 1 diabetes mellitus, and Addison's disease
- Evidence of an eating disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSD Health
La Jolla, California, 92093
Fernando Martinez, United States ext. 8585348930, fmartinez@health.ucsd.edu
Sanjay Agarwal, MD, United States ext. 8585348930, skagarwal@health.ucsd.edu
About this study
This randomized, controlled study will investigate the efficacy of a dietary intervention for women with endometriosis. Participants will be randomly assigned to follow a whole food plant-based (intervention) diet or stay on their usual (control) diet for 12 weeks.
Read the detailed description
This randomized, controlled study will investigate the efficacy of a dietary intervention for women with endometriosis. Participants will be randomly assigned to follow a whole food plant-based (intervention) diet or stay on their usual (control) diet for 12 weeks. We want to see if this diet improves and pain and quality of life in women with endometriosis.
- Conditions
- Endometriosis
- Being tested
- A whole food plant based diet
- Keywords
- endometriosis, pain, quality of life, inflammatory markers, diet, nutrition
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A whole food plant based dietOther
Also called WFPB
A whole food plant based (WFPB) diet
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm which will receive the intervention | Experimental | This group will receive the dietary intervention Receives: Other: A whole food plant based diet |
| Control | No intervention | This group with continue on their usual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain score
Change in total VAS for dysmenorrhea, dyspareunia and non-menstrual pelvic pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Nov 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled design with an active and control arms
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Agarwal, MD, University of California, San Diego
- Investigators
- Sanjay K Agarwal, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090096
- Sponsor's protocol ID
- 806685
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be proprietary
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Nutritional Intervention for Endometriosis
- ClinicalTrials.gov ID
- NCT07090096
- Acronym / sponsor ID
- 806685
- Conditions
- Endometriosis
- Keywords
- endometriosis, pain, quality of life, inflammatory markers, diet, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, controlled study will investigate the efficacy of a dietary intervention for women with endometriosis. Participants will be randomly assigned to follow a whole food plant-based (intervention) diet or stay on their usual (control) diet for 12 weeks.
Detailed description
This randomized, controlled study will investigate the efficacy of a dietary intervention for women with endometriosis. Participants will be randomly assigned to follow a whole food plant-based (intervention) diet or stay on their usual (control) diet for 12 weeks. We want to see if this diet improves and pain and quality of life in women with endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized controlled design with an active and control arms
| Arm | Type | Receives |
|---|---|---|
| Experimental arm which will receive the intervention | Experimental | Other: A whole food plant based dietThis group will receive the dietary intervention |
| Control | No intervention | –This group with continue on their usual diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study visits, procedures, requirements, and availability for the duration of the study
- Women with a surgical, imaging, or clinical diagnosis of endometriosis
- Age 18-45 years
- Stable health condition and medications for the past 3 months
Key exclusion criteria (8 listed)
- Smoking or drug abuse during the past six months
- Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
- Already following a WFPB diet
- Pregnant or breastfeeding, or plans of pregnancy within the study period
- Hysterectomy or ovariectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A whole food plant based dietAlso: WFPBA whole food plant based (WFPB) diet | Other | Experimental arm which will receive the intervention |
Primary outcome
Total pain score
Time frame: 12 weeks
Change in total VAS for dysmenorrhea, dyspareunia and non-menstrual pelvic pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. It will be proprietary
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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
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Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjay K Agarwal, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A whole food plant based diet in people with Endometriosis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloe Delgado Ramirez (619-929-0828, Krupp-wellness@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pain score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.