The Results of the Mediterranean Diet for PCOS

NCT06442189 | Completed DMC

• 1 other identifier: 01/06 22.01.2024
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis.

Conditions

Polycystic Ovary Syndrome; Diet Habit

Keywords

polycystic ovary syndrome; Mediterranean diet; obesity

Outcome Measures

Primary Outcomes (4)

• the effect of applying a Mediterranean diet on Homa-IR in PCOS

  Homeostasis model assessment (HoMA)-IR

  3 months

• PREDIMED in PCOS

  PREDIMED questionnaire

  3 months

• the effect of applying a Mediterranean diet on glucose in PCOS

  Fasting plasma glucose

  3 months

• the effect of applying a Mediterranean diet on HbA1c in PCOS

  HbA1c values

  3 months

Study Arms (1)

3. month

Once the baseline values have been determined at the first visit, all tests are repeated after the diet has been followed for 3 months.

Dietary Supplement: Mediterranean Diet

Interventions

Mediterranean Diet DIETARY_SUPPLEMENT

The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month of patients with a body mass index of 25 and more who were treated in our clinic due to a diagnosis of PCOS.

Also known as: Baseline, 3. Month

3. month

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People receiving care at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital who have a body mass index of 25 or more and follow a Mediterranean diet will be included in the study group. 98 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing will be included in the study. The study was designed to be prospective. Data will be collected after 0 and 3 months.

You may qualify if:

• At the age of 18-40 years,
• No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),
• With a body mass index of 25 and above,
• Female patients attending the PCOS clinic and under the care of our hospital's dietitian will be enrolled in the study.

You may not qualify if:

• Age \< 18 and \> 40 years;
• Menopause, pregnancy or breastfeeding in the last 6 months;
• Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary etiologies, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction and adrenal disorders),
• Pre-existing systemic or psychiatric disease
• Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills, metformin, anti-epileptics, antipsychotics, statins and fish oil);
• Certain eating regimens or hypocaloric diet in the last three months; supplementing with antioxidants, vitamins or minerals;
• Non-steroidal anti-inflammatory drugs, diuretics, etc. use of medications that may affect fluid balance
• Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of interference with device activity.

Sponsors & Collaborators

• Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital: lead

Study Sites (1)

Etlik Zübeyde Hanım

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

• Legro RS, Kunselman AR, Dodson WC, Dunaif A. Prevalence and predictors of risk for type 2 diabetes mellitus and impaired glucose tolerance in polycystic ovary syndrome: a prospective, controlled study in 254 affected women. J Clin Endocrinol Metab. 1999 Jan;84(1):165-9. doi: 10.1210/jcem.84.1.5393.

  PMID: 9920077 RESULT

• Barrea L, Arnone A, Annunziata G, Muscogiuri G, Laudisio D, Salzano C, Pugliese G, Colao A, Savastano S. Adherence to the Mediterranean Diet, Dietary Patterns and Body Composition in Women with Polycystic Ovary Syndrome (PCOS). Nutrients. 2019 Sep 23;11(10):2278. doi: 10.3390/nu11102278.

  PMID: 31547562 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Feeding Behavior; Obesity

Interventions

Diet, Mediterranean; BaseLine dental cement

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mujde Can Ibanoglu

  Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 4, 2024
• Study Start: September 20, 2024
• Primary Completion: October 7, 2024
• Study Completion: November 11, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)