Dieetstudie: The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Completed

CT.gov ID

NCT05714189

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Other: Low FODMAP diet Other: Endometriosis diet	N/A

Detailed Description

This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet. Women chosing to adhere to a diet were extensively guided by a dietician in training. In addition, both groups are asked to complete three questionnaires over a period of six months; once every two months.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Women could chose to adhere to a diet or the control group. there was no cross-over.Women could chose to adhere to a diet or the control group. there was no cross-over.

Masking:

None (Open Label)

Masking Description:

Women were able to choose themselves whether to adhere to a diet, and to which diet, or to adhere to the control group.

Primary Purpose:

Supportive Care

Official Title:

The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention group: adherence to Low FODMAP diet Women chould choose to adhere to the low FODMAP diet, over a period of six months. In the first three months, they reveiced extensive guidance by a dietician in training, in addition to supportive materials such as the Monash app, recipes and grocery lists, in the hope of optimal adherence to the diet. After three months, women were asked to continue the diet independently. In addition, women were asked to complete three questionnaires, one every two months. The questionnaires contained the EHP-30, the GIQLI, and self composed questions on their demographics in the first questionnaire, and their strictness of adherence in the second and third questionnaire. The third questionnaire also contained questions on their satisfaction with the dietary guidance and the dietician in training.	Other: Low FODMAP diet The Low FODMAP diet is an avoidance diet and consist of three phases. In the first phase, all nutrients high in FODMAPs (high-FODMAPS) are eliminated from the daily diet over a period of 2 to 6 weeks to calm down the bowel. The second phase consists of the addition of FODMAP challenges. During this phase the patient continues the Low FODMAP diet, but will reintroduce one high-FODMAP nutrient once every three days to see whether exposure to this high-FODMAP causes IBS symptoms. When this is not the case, the patient can continue eating this high-FODMAP group in their daily diet. In the third and final phase, the diet is fully personalized. This personalization is based on whether the patient tolerated the high-FODMAP nutrient or not during the FODMAP challenges. Only when the high-FODMAP nutrient is not tolerated, it is advised to permanently remove it from the daily diet.
Other: Intervention group: adherence to endometriosis diet Women chould choose to adhere to the endometriosis diet, over a period of six months. In the first three months, they reveiced extensive guidance by a dietician in training, in addition to supportive materials such as the Monash app, recipes and grocery lists, in the hope of optimal adherence to the diet. After three months, women were asked to continue the diet independently. In addition, women were asked to complete three questionnaires, one every two months. The questionnaires contained the EHP-30, the GIQLI, and self composed questions on their demographics in the first questionnaire, and their strictness of adherence in the second and third questionnaire. The third questionnaire also contained questions on their satisfaction with the dietary guidance and the dietician in training.	Other: Endometriosis diet The endometriosis diet The endometriosis diet is a patient experience based, avoidance diet developed by women diagnosed with endometriosis. Therefore no specific recommendations exist regarding the application of the endometriosis diet. With the endometriosis diet, women avoid nutrients they noticed provoked or aggravated their endometriosis-related symptoms such as red meat, coffee, sugar, lactose and soy.
No Intervention: Control group: no diet adherence Women were asked to complete three questionnaires, once every two months. These contained the EHP-30 and GIQLI. The first questionnaire contained questions on their demographics, and whether they applied a diet before.

Arm

Intervention/Treatment

Other: Intervention group: adherence to Low FODMAP diet

Women chould choose to adhere to the low FODMAP diet, over a period of six months. In the first three months, they reveiced extensive guidance by a dietician in training, in addition to supportive materials such as the Monash app, recipes and grocery lists, in the hope of optimal adherence to the diet. After three months, women were asked to continue the diet independently. In addition, women were asked to complete three questionnaires, one every two months. The questionnaires contained the EHP-30, the GIQLI, and self composed questions on their demographics in the first questionnaire, and their strictness of adherence in the second and third questionnaire. The third questionnaire also contained questions on their satisfaction with the dietary guidance and the dietician in training.

Other: Low FODMAP diet

The Low FODMAP diet is an avoidance diet and consist of three phases. In the first phase, all nutrients high in FODMAPs (high-FODMAPS) are eliminated from the daily diet over a period of 2 to 6 weeks to calm down the bowel. The second phase consists of the addition of FODMAP challenges. During this phase the patient continues the Low FODMAP diet, but will reintroduce one high-FODMAP nutrient once every three days to see whether exposure to this high-FODMAP causes IBS symptoms. When this is not the case, the patient can continue eating this high-FODMAP group in their daily diet. In the third and final phase, the diet is fully personalized. This personalization is based on whether the patient tolerated the high-FODMAP nutrient or not during the FODMAP challenges. Only when the high-FODMAP nutrient is not tolerated, it is advised to permanently remove it from the daily diet.

Other: Intervention group: adherence to endometriosis diet

Women chould choose to adhere to the endometriosis diet, over a period of six months. In the first three months, they reveiced extensive guidance by a dietician in training, in addition to supportive materials such as the Monash app, recipes and grocery lists, in the hope of optimal adherence to the diet. After three months, women were asked to continue the diet independently. In addition, women were asked to complete three questionnaires, one every two months. The questionnaires contained the EHP-30, the GIQLI, and self composed questions on their demographics in the first questionnaire, and their strictness of adherence in the second and third questionnaire. The third questionnaire also contained questions on their satisfaction with the dietary guidance and the dietician in training.

Other: Endometriosis diet

The endometriosis diet The endometriosis diet is a patient experience based, avoidance diet developed by women diagnosed with endometriosis. Therefore no specific recommendations exist regarding the application of the endometriosis diet. With the endometriosis diet, women avoid nutrients they noticed provoked or aggravated their endometriosis-related symptoms such as red meat, coffee, sugar, lactose and soy.

No Intervention: Control group: no diet adherence

Women were asked to complete three questionnaires, once every two months. These contained the EHP-30 and GIQLI. The first questionnaire contained questions on their demographics, and whether they applied a diet before.

Outcome Measures

Primary Outcome Measures

pain scores [6 months]
The primary outcome focused on pain scores (in VAS, scale 0-10cm) of the endometriosis-related symptoms dysmenorrhea, deep dyspareunia, chronic pelvic pain, dysuria, dyschezia, tiredness and bloating.

Secondary Outcome Measures

Quality of Life (QoL) [6 months]
Secondary outcome focused on QoL, expressed using the EHP-30 questionnaire
Gastro-Intestinal Health [6 months]
Secondary outcome focused on gastro-intestinal health, expressed using the GIQLI questionnaire
Adhesion to dietary intervention [6 months]
with every follow-up visit, women were asked on their dietary adhesion. they were asked how often they made an exeption, with what meal (snack/main meal) and what strictness score they gave themselves.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women diagnosed with endometriosis, either through radiologic imaging (transvaginal ultrasound and/or MRI) or laparoscopy
A reported pain score of ≥ 3 (Visual Analogue Score (VAS), scale 0-10cm) in one or more of the following symptoms: dysmenorrhea, deep dyspareunia and chronic pelvic pain

Exclusion Criteria:

about to undergo an operation within six months
Undergone an operation in the past six weeks
a switch in hormonal therapy within six weeks
Women that were pregnant or breastfeeding
women diagnosed with a malignancy
An additional diagnosis with Coeliac Disease (CD) and/or lactose intolerance.
Not sufficient in the Dutch or English language.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amsterdam AMC	Amsterdam		Netherlands	1081HV

Sponsors and Collaborators

Amsterdam UMC, location VUmc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Velja Mijatovic, Professor Doctor, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT05714189

Other Study ID Numbers:

W20_534 # 20.593

First Posted:

Feb 6, 2023

Last Update Posted:

Feb 6, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Feb 6, 2023