AMHAMHNCT06426771
Effect of Antimullerian Hormone Levels on the Inflammatory Index, Phytochemical Index and NRF Nutrient Density
An observational study of AMH and Diet Habit, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- AMH, Diet Habit, Ovarian Failure
- What is being tested?
- Dietary Inflammatory Index and hormone profile
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2024to 10 Nov 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Dietary Inflammatory Index, Dietary Phytochemical Index and NRF Nutrient Density in Patients With High and Low Antimullerian Hormone Levels
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.
Read the detailed description
There is currently growing interest in the relationship between lifestyle, reproductive health and fertility. Recent research emphasizes the influence of environmental and lifestyle factors such as stress, diet and nutritional status on reproductive health. Ovarian reserve refers to the number and quality of eggs and is an indicator of reproductive potential. Ovarian reserve is inversely proportional to the chronological age of the mother, which is the most important determinant of reproductive capacity and reproductive success. It has been shown that reproductive aging accelerates after the age of 35. Therefore, the assessment of ovarian reserve is an important step in both the evaluation and treatment of infertility. Markers of ovarian reserve include antral follicle count (AFC), which is determined by transvaginal ultrasound, and serum levels of various biomarkers such as anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol. Studies show that certain dietary patterns and the intake of certain nutrients are associated with endometriosis, ovarian reserve and egg quality, ovarian infertility and fertility. In addition, there is evidence that modifiable lifestyle factors, such as adherence to certain dietary habits and avoidance of environmental toxins, may also have positive effects on ovarian reserve. Recent studies have shown that women's nutritional status, body mass index and eating habits influence ovarian reserve.
The Dietary Inflammatory Index (DII) is an index developed to assess the impact of general dietary habits on inflammation. It is known that the dietary inflammatory index is high in chronic diseases associated with inflammation. The Phytochemical Index is a calculation based on the consumption of fruits high in phytochemicals, all vegetables except potatoes, legumes, whole grains and whole grain-containing foods, and oilseeds that provides information about the level of phytochemicals in the diet. The NRF Nutrient Density Index is a continuous function and represents an arithmetic combination of weighted variables. In this continuous function algorithm, the negative part (foods that should be restricted) is subtracted from the positive part (foods that should be consumed). In the calculation phase of this model, foods were scored according to their nutrient content per 100 kcal and per serving size. By calculating the nutrient density of the food consumed, the quality of the person's diet can be determined.
Based on this information, it was planned to compare these 3 nutritional indices in patients diagnosed with PCOS with an AMH level above 3.32 ng/ml, in the low ovarian reserve group without a PCOS diagnosis with an AMH level below 1.2 ng/ml and in normo-responder patients with an AMH level between these two values.
- Conditions
- AMH, Diet Habit, Ovarian Failure, Polycystic Ovary Syndrome
- Being tested
- Dietary Inflammatory Index, hormone profile
- Keywords
- NRF Nutrient Density Index, Dietary Inflammatory Index, Phytochemical Index, anti-Müllerian hormone
- Medical subject headings
- Feeding Behavior, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Inflammatory IndexBehavioural
Also called Dietary Phytochemical Index, Nutrient Rich Food Index
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.
hormone profileDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Low AMH Levels- | AMH levels: those with low AMH levels (<1.2 ng/ml): 30 participants Receives: Behavioral: Dietary Inflammatory Index; Diagnostic Test: hormone profile | |
| Normal AMH levels- | normal AMH levels (1.2-3.32 ng/ml): 30 participants Receives: Behavioral: Dietary Inflammatory Index; Diagnostic Test: hormone profile | |
| High AMH levels- | high AMH levels (>3.32 ng/ml): 30 Participants Receives: Behavioral: Dietary Inflammatory Index; Diagnostic Test: hormone profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start20 Sep 2024
- Primary completion1 Oct 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AMHStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde Can Ibanoglu, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Mujde Can Ibanoglu, Principal investigator, Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426771
- Sponsor's protocol ID
- 02/10 28.02.2024
- Acronym
- AMH
- Status last verified
- Nov 2024
- First submitted
- 18 May 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36904180Barrea 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.
PubMed 31547562
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dietary Inflammatory Index, Dietary Phytochemical Index and NRF Nutrient Density in Patients With High and Low Antimullerian Hormone Levels
- ClinicalTrials.gov ID
- NCT06426771
- Acronym / sponsor ID
- AMH / 02/10 28.02.2024
- Conditions
- AMH, Diet Habit, Ovarian Failure, Polycystic Ovary Syndrome
- Keywords
- NRF Nutrient Density Index, Dietary Inflammatory Index, Phytochemical Index, anti-Müllerian hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 23 May 2024 (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.
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.
Detailed description
There is currently growing interest in the relationship between lifestyle, reproductive health and fertility. Recent research emphasizes the influence of environmental and lifestyle factors such as stress, diet and nutritional status on reproductive health. Ovarian reserve refers to the number and quality of eggs and is an indicator of reproductive potential. Ovarian reserve is inversely proportional to the chronological age of the mother, which is the most important determinant of reproductive capacity and reproductive success. It has been shown that reproductive aging accelerates after the age of 35. Therefore, the assessment of ovarian reserve is an important step in both the evaluation and treatment of infertility. Markers of ovarian reserve include antral follicle count (AFC), which is determined by transvaginal ultrasound, and serum levels of various biomarkers such as anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol. Studies show that certain dietary patterns and the intake of certain nutrients are associated with endometriosis, ovarian reserve and egg quality, ovarian infertility and fertility. In addition, there is evidence that modifiable lifestyle factors, such as adherence to certain dietary habits and avoidance of environmental toxins, may also have positive effects on ovarian reserve. Recent studies have shown that women's nutritional status, body mass index and eating habits influence ovarian reserve.
The Dietary Inflammatory Index (DII) is an index developed to assess the impact of general dietary habits on inflammation. It is known that the dietary inflammatory index is high in chronic diseases associated with inflammation. The Phytochemical Index is a calculation based on the consumption of fruits high in phytochemicals, all vegetables except potatoes, legumes, whole grains and whole grain-containing foods, and oilseeds that provides information about the level of phytochemicals in the diet. The NRF Nutrient Density Index is a continuous function and represents an arithmetic combination of weighted variables. In this continuous function algorithm, the negative part (foods that should be restricted) is subtracted from the positive part (foods that should be consumed). In the calculation phase of this model, foods were scored according to their nutrient content per 100 kcal and per serving size. By calculating the nutrient density of the food consumed, the quality of the person's diet can be determined.
Based on this information, it was planned to compare these 3 nutritional indices in patients diagnosed with PCOS with an AMH level above 3.32 ng/ml, in the low ovarian reserve group without a PCOS diagnosis with an AMH level below 1.2 ng/ml and in normo-responder patients with an AMH level between these two values.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low AMH Levels- | – | Behavioral: Dietary Inflammatory Index, Diagnostic Test: hormone profileAMH levels: those with low AMH levels (<1.2 ng/ml): 30 participants |
| Normal AMH levels- | – | Behavioral: Dietary Inflammatory Index, Diagnostic Test: hormone profilenormal AMH levels (1.2-3.32 ng/ml): 30 participants |
| High AMH levels- | – | Behavioral: Dietary Inflammatory Index, Diagnostic Test: hormone profilehigh AMH levels (>3.32 ng/ml): 30 Participants |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
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 |
|---|---|---|
| Dietary Inflammatory IndexAlso: Dietary Phytochemical Index, Nutrient Rich Food IndexThe 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. | Behavioural | High AMH levels-, Low AMH Levels-, Normal AMH levels- |
| hormone profileIn 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. | Diagnostic test | High AMH levels-, Low AMH Levels-, Normal AMH levels- |
Primary outcome
AMH levels according to dietary indexes
Time frame: 6 months
Patients with low, normal and high AMH values are examined for differences in the indices calculated according to nutrient density.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 36904180Lakoma 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.
- Results publication: PubMed 31547562Barrea 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.
- Individual participant dataSharing planned: Undecided
Related trials for AMH
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
RecruitingObservational study
Anti-Müllerian Hormone in Breast Cancer Clinical Practice
Breast Cancer
Recruiting
Anti-mullerian Hormone Levels in Healthy Females
Healthy
Recruiting
Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)
Polycystic Ovarian Syndrome in Adolescent Females, Vitamin D Deficiency
Not yet recruiting
Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography
Ovarian Reserve Markers, Ovarian Function
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. This study is not recruiting at the moment.
Mujde Can Ibanoglu principal investigator
Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMH and Diet Habit, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 19 Nov 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH levels according to dietary indexes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426771, which also lists 2 linked publications.
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 19 Nov 2024.