Polycystic Ovary SyndromeNCT05830487
Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients
A study testing Low AGE diet with reduced energy and fat and Energy and fat-reduced normal diet in people with Polycystic Ovary Syndrome and Diet Habit, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Recently, the negative effects of advanced glycation end products on the pathophysiology of some diseases have attracted attention. This study was planned to evaluate the effect of dietary intervention and weight loss on serum advanced glycation and disease pathogenesis in patients with polycystic ovary syndrome. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Diet Habit
- What is being tested?
- Low AGE diet with reduced energy and fat and Energy and fat-reduced normal diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2021to Nov 2023
- Phase
- Interventional
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Presence of chronic disease (Diabetes, Hypertension, Atherosclerotic heart diseases, gastrointestinal system diseases..)
- Being in pregnancy-lactation or menopause period
- Using oral contraceptive medication
- Using vitamin-mineral support
- Receiving a special dietary treatment
- To have applied a weight loss diet in the last 3 months
- To smoke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dietary Intervention on Serum Advanced Glycation End Products and Metabolic Profile in Polycystic Ovary Syndrome Patients
Recently, the negative effects of advanced glycation end products on the pathophysiology of some diseases have attracted attention. This study was planned to evaluate the effect of dietary intervention and weight loss on serum advanced glycation and disease pathogenesis in patients with polycystic ovary syndrome.
Read the detailed description
The significantly increased consumption of processed foods in recent years has also increased the amount of sugar and fat in the diet. These changes in dietary habits also increase exposure to advanced glycation end products. Advanced glycation end products (AGEs) are the products occurred as a result of the Maillard reaction by the combination of the carbonyl group of carbohydrates and the free amino groups of amino acids. Advance glycation end products causes irreversible cross-linking of proteins, resulting in loss of protein structure and function. Advanced glycation end products formation is a slow process in normal conditions, but chronic diseases such as diabetes, insulin resistance, aging, oxidative stress and PCOS accelerate the occurrence of endogenous AGEs.
Polycystic ovary syndrome (PCOS) is an endocrine disorder that is characterized by hyperandrogenism, oligo/anovulation and polycystic ovaries and it affects up to 25% of reproductive-aged women. Women with PCOS have been shown to have an increase in the levels of AGEs in the bloodstream and the expression of proinflammatory receptors of AGEs in the ovaries, such as RAGE. In addition, the levels of protective anti-inflammatory receptors called soluble receptors for advanced glycation end products (sRAGE) were found to be low in women with PCOS. Patient with PCOS in particular have high levels of serum AGEs, regardless of their body weight or the presence of insulin resistance.
In this project, aimed to investigate effect of a diet with reduced energy and fat content and a low AGE diet with reduced energy and fat content for 12 weeks in overweight and obese individuals with polycystic ovary syndrome.
Body composition, anthropometric measurements, serum AGE levels, serum antioxidant capacity, inflammation, cardio metabolic profile, hormonal profile, and also Anti-Mullerian Hormone (AMH) values will be examined in individuals and the results will be evaluated by comparing diet groups. Volunteers participating in the study will apply one of two different dietary treatments to be determined by stratified randomization method for 12 weeks. The smallest sample size was calculated as a total of 24 patients, 12 patients in each intervention group, taking into account the change in serum AGE value at 80% power and 95% confidence intervals.
- Conditions
- Polycystic Ovary Syndrome, Diet Habit
- Being tested
- Low AGE diet with reduced energy and fat, Energy and fat-reduced normal diet
- Keywords
- advanced glycation end products, diet
- Medical subject headings
- Polycystic Ovary Syndrome, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low AGE diet with reduced energy and fatBehavioural
This group will be given a low AGE diet with reduced energy and fat,.
Energy and fat-reduced normal dietBehavioural
This group will be given a diet with reduced energy and fat, and AGE levels will not be interfered with
| Study group | Role | What they receive |
|---|---|---|
| Low AGE diet with reduced energy and fat | Experimental | Low advanced glycation end products diet with reduced energy and fat Receives: Behavioral: Low AGE diet with reduced energy and fat |
| Energy and fat-reduced normal diet | Experimental | only energy and fat-reduced diet, advanced glycation end products intake will not be interfered with. Receives: Behavioral: Energy and fat-reduced normal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum advanced glycation end products levels
The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention
Measured: 12 weeks
Total antioxidant/oxidant capacity
The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention
Measured: 12 weeks
İnflammation
The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention
Measured: 12 weeks
Cardio metabolic profile
The comparison of fasting insulin (mg/dL), fasting blood sugar (mg/dL), lipid parameters (triglyceride (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), total cholesterol (mg/dL)) values of 24 patients at baseline and week 12.
Measured: 12 weeks
Hormonal Profile
From hormonal indicators total testosterone (ng/mL), sex hormone-binding globulin ng/mL) , Anti mullerian hormone (ng/mL) values of 24 patients at baseline and week 12 will be compared.
Measured: 12 weeks
Secondary outcomes (4)
Body composition
The comparison of body fat percentage of 24 patients at baseline and week 12
Measured: 12 weeks
Body weight
The comparison of body weight (kg) of 24 patients at baseline and week 12
Measured: 12 weeks
Body Mass İndex
Body mass index (kg/m^2) of 24 patients at baseline and week 12 will be compared
Measured: 12 weeks
Circumference measurements
waist circumference (cm) and hip circumference (cm) of 24 patients at baseline and week 12 will be compared
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start30 Nov 2021
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Özdemir, Hacettepe University
- Investigators
- merve özdemir, Principal investigator, researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830487
- Sponsor's protocol ID
- HACETTEPE UNIVERSITY-OZDEMIR-1
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozdemir M, Mumusoglu S, Bilgic P. Comparison of Metabolic and Hormonal Profiles between Low-Advanced Glycation End Products (AGEs) and Standard AGEs-Containing Weight-Loss Diets in Overweight Phenotype-A PCOS Patients: A Randomized Clinical Trial. Reprod Sci. 2025 Apr;32(4):1190-1201. doi: 10.1007/s43032-025-01808-8. Epub 2025 Feb 14.
PubMed 39953370
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Intervention on Serum Advanced Glycation End Products and Metabolic Profile in Polycystic Ovary Syndrome Patients
- ClinicalTrials.gov ID
- NCT05830487
- Acronym / sponsor ID
- HACETTEPE UNIVERSITY-OZDEMIR-1
- Conditions
- Polycystic Ovary Syndrome, Diet Habit
- Keywords
- advanced glycation end products, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 26 Apr 2023 (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.
Recently, the negative effects of advanced glycation end products on the pathophysiology of some diseases have attracted attention. This study was planned to evaluate the effect of dietary intervention and weight loss on serum advanced glycation and disease pathogenesis in patients with polycystic ovary syndrome.
Detailed description
The significantly increased consumption of processed foods in recent years has also increased the amount of sugar and fat in the diet. These changes in dietary habits also increase exposure to advanced glycation end products. Advanced glycation end products (AGEs) are the products occurred as a result of the Maillard reaction by the combination of the carbonyl group of carbohydrates and the free amino groups of amino acids. Advance glycation end products causes irreversible cross-linking of proteins, resulting in loss of protein structure and function. Advanced glycation end products formation is a slow process in normal conditions, but chronic diseases such as diabetes, insulin resistance, aging, oxidative stress and PCOS accelerate the occurrence of endogenous AGEs.
Polycystic ovary syndrome (PCOS) is an endocrine disorder that is characterized by hyperandrogenism, oligo/anovulation and polycystic ovaries and it affects up to 25% of reproductive-aged women. Women with PCOS have been shown to have an increase in the levels of AGEs in the bloodstream and the expression of proinflammatory receptors of AGEs in the ovaries, such as RAGE. In addition, the levels of protective anti-inflammatory receptors called soluble receptors for advanced glycation end products (sRAGE) were found to be low in women with PCOS. Patient with PCOS in particular have high levels of serum AGEs, regardless of their body weight or the presence of insulin resistance.
In this project, aimed to investigate effect of a diet with reduced energy and fat content and a low AGE diet with reduced energy and fat content for 12 weeks in overweight and obese individuals with polycystic ovary syndrome.
Body composition, anthropometric measurements, serum AGE levels, serum antioxidant capacity, inflammation, cardio metabolic profile, hormonal profile, and also Anti-Mullerian Hormone (AMH) values will be examined in individuals and the results will be evaluated by comparing diet groups. Volunteers participating in the study will apply one of two different dietary treatments to be determined by stratified randomization method for 12 weeks. The smallest sample size was calculated as a total of 24 patients, 12 patients in each intervention group, taking into account the change in serum AGE value at 80% power and 95% confidence intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low AGE diet with reduced energy and fat | Experimental | Behavioral: Low AGE diet with reduced energy and fatLow advanced glycation end products diet with reduced energy and fat |
| Energy and fat-reduced normal diet | Experimental | Behavioral: Energy and fat-reduced normal dietonly energy and fat-reduced diet, advanced glycation end products intake will not be interfered with. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Presence of chronic disease (Diabetes, Hypertension, Atherosclerotic heart diseases, gastrointestinal system diseases..)
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 |
|---|---|---|
| Low AGE diet with reduced energy and fatThis group will be given a low AGE diet with reduced energy and fat,. | Behavioural | Low AGE diet with reduced energy and fat |
| Energy and fat-reduced normal dietThis group will be given a diet with reduced energy and fat, and AGE levels will not be interfered with | Behavioural | Energy and fat-reduced normal diet |
Primary outcome
Serum advanced glycation end products levels
Time frame: 12 weeks
The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention
Total antioxidant/oxidant capacity
Time frame: 12 weeks
The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention
İnflammation
Time frame: 12 weeks
The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention
Cardio metabolic profile
Time frame: 12 weeks
The comparison of fasting insulin (mg/dL), fasting blood sugar (mg/dL), lipid parameters (triglyceride (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), total cholesterol (mg/dL)) values of 24 patients at baseline and week 12.
Hormonal Profile
Time frame: 12 weeks
From hormonal indicators total testosterone (ng/mL), sex hormone-binding globulin ng/mL) , Anti mullerian hormone (ng/mL) values of 24 patients at baseline and week 12 will be compared.
4 secondary outcomes
Body composition
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Body Mass İndex
Time frame: 12 weeks
Circumference measurements
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 39953370Ozdemir M, Mumusoglu S, Bilgic P. Comparison of Metabolic and Hormonal Profiles between Low-Advanced Glycation End Products (AGEs) and Standard AGEs-Containing Weight-Loss Diets in Overweight Phenotype-A PCOS Patients: A Randomized Clinical Trial. Reprod Sci. 2025 Apr;32(4):1190-1201. doi: 10.1007/s43032-025-01808-8. Epub 2025 Feb 14.
- Individual participant dataSharing planned: No
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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.
merve özdemir principal investigator
researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low AGE diet with reduced energy and fat and Energy and fat-reduced normal diet in people with Polycystic Ovary Syndrome and Diet Habit, run by Hacettepe University 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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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?
Results are not available in the source record.
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?
Serum advanced glycation end products levels (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT05830487, which also lists 1 linked publication.
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 26 Apr 2023.