Effect of Antimullerian Hormone Levels on the Inflammatory Index, Phytochemical Index and NRF Nutrient Density

NCT06426771 | Completed DMC

• 1 other identifier: 02/10 28.02.2024
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to calculate the dietary inflammatory index, dietary phytochemical index and NRF nutrient density of the dietary pattern routinely consumed by women and to assess whether there is a difference between PCOS patients with high AMH levels and the group with low AMH levels.

Conditions

AMH; Diet Habit; Ovarian Failure; Polycystic Ovary Syndrome

Keywords

NRF Nutrient Density Index; Dietary Inflammatory Index; Phytochemical Index; anti-Müllerian hormone

Outcome Measures

Primary Outcomes (1)

• AMH levels according to dietary indexes

  Patients with low, normal and high AMH values are examined for differences in the indices calculated according to nutrient density.

  6 months

Study Arms (3)

Low AMH Levels-

AMH levels: those with low AMH levels (\<1.2 ng/ml): 30 participants

Behavioral: Dietary Inflammatory Index; Diagnostic Test: hormone profile

Normal AMH levels-

normal AMH levels (1.2-3.32 ng/ml): 30 participants

Behavioral: Dietary Inflammatory Index; Diagnostic Test: hormone profile

High AMH levels-

high AMH levels (\>3.32 ng/ml): 30 Participants

Behavioral: Dietary Inflammatory Index; Diagnostic Test: hormone profile

Interventions

Dietary Inflammatory Index BEHAVIORAL

The aim of this study was to compare the dietary habits of patients with PCOS and an AMH value of \>3.32 ng/ml, of patients with low ovarian reserve without PCOS and an AMH value of less than 1.2 ng/ml and of patients with normal AMH values (between 1.2-3.32 ng/ml) according to Dietary Nutrient Density according to Dietary Inflammatory Index, Dietary Phytochemical Index and Nutrient Rich Food Index.

Also known as: Dietary Phytochemical Index, Nutrient Rich Food Index

High AMH levels-; Low AMH Levels-; Normal AMH levels-

hormone profile DIAGNOSTIC_TEST

In the routine practice of the PCOS clinic, about 7 ml of blood is taken in a vacuum gel tube for hormonal and biochemical analysis by medical staff. The blood samples are centrifuged by the researchers at 1000xg for 20 minutes. In the next step, the supernatant part is separated and transferred to 3 mL Ependorfs. These samples are used to determine the levels of anti-Müllerian hormone (AMH), oestradiol, LH and FSH, which are routinely determined at the PCOS clinic.

High AMH levels-; Low AMH Levels-; Normal AMH levels-

Eligibility Criteria

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

Study Population

This study was designed as a cross-sectional cohort study including individuals who were followed up in the PCOS Clinic and dietetic department of Etlik Zübeyde Hanım Gynaecology Training and Research Hospital. Patients will be divided into 3 groups according to AMH value as those with low AMH value, those with normal AMH value and those with high AMH value (11). The study will include 90 individuals who agreed to be included in the study and accepted the consent form verbally and in writing.

You may qualify if:

• Between the ages of 18 and 40,
• No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),
• Female patients with AMH levels in our hospital,
• Participants attending the PCOS clinic and under the care of our hospital 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 causes, including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia, thyroid dysfunction, and adrenal disease),
• Pre-existing systemic or psychiatric illnesses
• Taking medication that affects carbohydrate or fat metabolism (contraceptive pills, metformin, antiepileptic drugs, antipsychotics, statins and fish oil);
• Certain nutritional therapies or hypocaloric diet in the last three months; supplementation with antioxidants, vitamins or minerals;
• Taking medications that can affect fluid balance, such as non-steroidal anti-inflammatory drugs, diuretics, etc.
• Female patients with implanted pacemakers or defibrillators due to the theoretical possibility of impaired 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)

• Lakoma K, Kukharuk O, Sliz D. The Influence of Metabolic Factors and Diet on Fertility. Nutrients. 2023 Feb 27;15(5):1180. doi: 10.3390/nu15051180.

  PMID: 36904180 BACKGROUND

• 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

Feeding Behavior; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; 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

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: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 23, 2024
• Study Start: September 20, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 10, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

TU (1)