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Effects of ketogenic diet in patients with endometriosis

Investigating the effects of MCT-modified ketogenic diet on clinical symptoms, systemic inflammation and the expression of gene coding B-catenin in patients with endometriosis: A parallel randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131125015536N15
Enrollment
50
Registered
2024-07-24
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis. Endometriosis of uterus

Interventions

Intervention 1: Intervention group: In addition to the prescription of the standard drug regimen, i.e., oral contraceptive pills, the intervention of the ketogenic diet is explained to the patients of

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 35 Years

Inclusion criteria

Inclusion criteria: Age range between 25 and 35 years being married Diagnosis of endometriosis based on laparoscopic and pathological findings Having stage one or two endometriosis based on diagnostic laparoscopy or patients with a higher grade who underwent diagnostic-therapeutic laparoscopy and 3 months after laparoscopy, their disease stage was reduced to stage one or two Body mass index between 21 and 25 kg/m2 Having a VAS score of 3 out of 10 or greater than 3 out of 10 for pelvic pain and dyspareunia (pain during intercourse) and dyschezia (pain during defecation)

Exclusion criteria

Exclusion criteria: Smoking and alcohol consumption Taking antidepressants for the past 6 months Pregnancy, breastfeeding and menopause Women who intend to become pregnant or take drugs such as clomifene, letrozole and gonadotropin Intestinal malabsorption (history of bariatric surgery, inflammatory bowel disease, celiac disease) Suffering from other diseases such as kidney disease and kidney stones, liver disorders and gallstones, cancer, heart diseases, acute and chronic infectious diseases, type 1 and 2 diabetes, Cushing's disease, acromegaly, and gigantism. Having myoma or polyps in the uterus

Design outcomes

Primary

MeasureTime frame
Expression of the gene coding beta-catenin protein. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the intervention). Method of measurement: RT-PCR method.;Score of clinical symptoms including pelvic pain, dyspareunia, and dyschezia. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the intervention). Method of measurement: visual analog scale.

Secondary

MeasureTime frame
Anthropometric measurements including weight, body mass index, waist circumference. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: By a trained person using a scale and tape measure and calculating body mass index using the formula.;Systemic inflammation indices including neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and systemic inflammation response index. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Using the formula and data from the complete blood cell count test.;Lipid profile including total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Photometric method using laboratory kits.;Liver enzymes (ALT and AST). Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Enzymatic method using laboratory kits.;Systolic and diastolic blood pressure. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of the intervention). Method of measurement: Sphygmomanometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Javad Hosseinzadeh Attar

Tehran University of Medical Sciences

Hosseinzadeh.md.phd@gmail.com+98 21 8895 5742

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026