PCOS (Polycystic Ovary Syndrome)NCT07342946
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
A study testing Synbiotic Supplement in people with PCOS (Polycystic Ovary Syndrome), run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Synbiotic Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women who are overweight or obese, with a body mass index (BMI) between 25 and 35 kg/m²
- Aged 18 to 45 years (reproductive age)
- Diagnosed with polycystic ovary syndrome (PCOS)
- No underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet
Who cannot join
- Pregnancy or breastfeeding within the past 6 months
- Presence of comorbid conditions, including kidney, liver, or cardiovascular disease, gout, hyperuricemia, or other related disorders
- Use of oral contraceptives
- Following a special dietary treatment or a hypocaloric diet within the last 3 months
- Occasional or current use of medications that may affect fluid balance, including diuretics and laxatives
- Participants will be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atlas University
Istanbul, Istanbul, 34040
Aysenur Calik, Msc,, +905315239218, ayse.emirhuseyinoglu@atlas.edu.tr
About this study
Official title: Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome
This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Participants will be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a placebo (a look-alike product with no active ingredients). All participants will follow the same reduced-calorie Mediterranean diet for 8 weeks. The study team will measure body composition and weight-related measurements, and will collect blood samples to evaluate selected laboratory markers before and after the 8-week period. Participants will also complete the PCOSQ-50 quality-of-life questionnaire before and after the intervention. The goal is to better understand the possible role of synbiotic supplementation alongside dietary treatment in PCOS.
Read the detailed description
This randomized, placebo-controlled, single-blind clinical trial is designed to evaluate the effects of a hypocaloric Mediterranean diet combined with synbiotic supplementation on anthropometric measurements, biochemical parameters, and quality of life in overweight and obese women diagnosed with polycystic ovary syndrome (PCOS). Eligible participants will be randomly assigned to one of two study arms: a synbiotic supplementation group or a placebo group. Both groups will follow the same hypocaloric Mediterranean diet throughout the 8-week intervention period.
Anthropometric assessments, including body weight, body mass index, waist circumference, and body composition, will be performed at baseline and at the end of the intervention. Biochemical parameters will be evaluated through blood samples collected at baseline and after 8 weeks. Quality of life will be assessed using the PCOSQ-50 Quality of Life Questionnaire at both time points.
The study aims to determine whether the addition of synbiotic supplementation to a hypocaloric Mediterranean diet provides additional benefits in the management of PCOS-related metabolic parameters and quality of life compared with dietary intervention alone.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Synbiotic Supplement, Placebo
- Keywords
- synbiotics, pcos, diet, nutrition
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic SupplementDietary supplement
Also called Mediterrenean Diet
Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks.
PlaceboOther
Also called Mediterrenean Diet
Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks. Receives: Other: Placebo |
| Synbiotics | Active comparator | Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks. Receives: Dietary Supplement: Synbiotic Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Changes in body weight measured in kilograms using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in body mass index (BMI)
Changes in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), with body weight measured using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in body composition
Changes in body composition parameters, including fat mass and fat-free mass, assessed using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in waist circumference
Changes in waist circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in hip circumference
Changes in hip circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Change in insulin resistance (HOMA-IR)
Changes in insulin resistance assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting insulin levels. A HOMA-IR value below 2.5 will be considered indicative of the absence of insulin resistance. Measurements will be performed at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in fasting blood glucose
Changes in fasting blood glucose levels measured in mg/dL from venous blood samples collected at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in lipid profile
Changes in serum lipid profile parameters, including high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and total cholesterol, measured in mg/dL from venous blood samples collected at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in follicle-stimulating hormone (FSH) levels
Changes in serum follicle-stimulating hormone (FSH) levels measured from venous blood samples collected at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in luteinizing hormone (LH) levels
Changes in serum luteinizing hormone (LH) levels measured from venous blood samples collected at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Change in quality of life
Changes in quality of life assessed using the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOSQ-50), a validated disease-specific instrument consisting of 50 items across six domains: psychosocial and emotional well-being, fertility, sexual function, obesity and menstrual irregularity, hirsutism, and coping with the disease. Each item is scored on a 5-point Likert scale ranging from 1 (always) to 5 (never), resulting in a total score range of 50 to 250. Higher scores indicate better quality of life. Domain scores are calculated as the mean of the items answered within each domain, excluding unanswered items. Assessments will be performed at baseline and after the 8-week intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start20 Dec 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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 PCOS (Polycystic Ovary Syndrome)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Emirhuseyinoglu Calik, Atlas University
- Investigators
- Derya Sivri-Aydın, Study director, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342946
- Sponsor's protocol ID
- E-22686390-050.99-78501
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hariri Z, Yari Z, Hoseini S, Abhari K, Sohrab G. Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial. BMC Womens Health. 2024 Jan 3;24(1):19. doi: 10.1186/s12905-023-02868-1.
PubMed 38172876Koyutürk, G., & Külünkoğlu, B. A. (2023). Polikistik Over Sendromu Yaşam Kalitesi-50 Ölçeği'nin Türkçe uyarlamasının geçerlik ve güvenirliği. Sağlık ve Yaşam Bilimleri Dergisi, 5(2), 63-70.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07342946
- Acronym / sponsor ID
- E-22686390-050.99-78501
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- synbiotics, pcos, diet, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 20 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Participants will be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a placebo (a look-alike product with no active ingredients). All participants will follow the same reduced-calorie Mediterranean diet for 8 weeks. The study team will measure body composition and weight-related measurements, and will collect blood samples to evaluate selected laboratory markers before and after the 8-week period. Participants will also complete the PCOSQ-50 quality-of-life questionnaire before and after the intervention. The goal is to better understand the possible role of synbiotic supplementation alongside dietary treatment in PCOS.
Detailed description
This randomized, placebo-controlled, single-blind clinical trial is designed to evaluate the effects of a hypocaloric Mediterranean diet combined with synbiotic supplementation on anthropometric measurements, biochemical parameters, and quality of life in overweight and obese women diagnosed with polycystic ovary syndrome (PCOS). Eligible participants will be randomly assigned to one of two study arms: a synbiotic supplementation group or a placebo group. Both groups will follow the same hypocaloric Mediterranean diet throughout the 8-week intervention period.
Anthropometric assessments, including body weight, body mass index, waist circumference, and body composition, will be performed at baseline and at the end of the intervention. Biochemical parameters will be evaluated through blood samples collected at baseline and after 8 weeks. Quality of life will be assessed using the PCOSQ-50 Quality of Life Questionnaire at both time points.
The study aims to determine whether the addition of synbiotic supplementation to a hypocaloric Mediterranean diet provides additional benefits in the management of PCOS-related metabolic parameters and quality of life compared with dietary intervention alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks. |
| Synbiotics | Active comparator | Dietary Supplement: Synbiotic SupplementParticipants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal women who are overweight or obese, with a body mass index (BMI) between 25 and 35 kg/m²
- Aged 18 to 45 years (reproductive age)
- Diagnosed with polycystic ovary syndrome (PCOS)
- No underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding within the past 6 months
- Presence of comorbid conditions, including kidney, liver, or cardiovascular disease, gout, hyperuricemia, or other related disorders
- Use of oral contraceptives
- Following a special dietary treatment or a hypocaloric diet within the last 3 months
- Occasional or current use of medications that may affect fluid balance, including diuretics and laxatives
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 |
|---|---|---|
| Synbiotic SupplementAlso: Mediterrenean DietParticipants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks. | Dietary supplement | Synbiotics |
| PlaceboAlso: Mediterrenean DietParticipants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks. | Other | Placebo |
Primary outcome
Change in body weight
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in body weight measured in kilograms using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Change in body mass index (BMI)
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²), with body weight measured using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Change in body composition
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in body composition parameters, including fat mass and fat-free mass, assessed using the Tanita MC-780 bioelectrical impedance analysis (BIA) device at baseline and after the 8-week intervention.
Change in waist circumference
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in waist circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
Change in hip circumference
Time frame: From enrollment to the end of treatment at 8 weeks
Changes in hip circumference measured in centimeters using a non-elastic measuring tape at baseline and after the 8-week intervention.
6 secondary outcomes
Change in insulin resistance (HOMA-IR)
Time frame: From enrollment to the end of treatment at 8 weeks
Change in fasting blood glucose
Time frame: From enrollment to the end of treatment at 8 weeks
Change in lipid profile
Time frame: From enrollment to the end of treatment at 8 weeks
Change in follicle-stimulating hormone (FSH) levels
Time frame: From enrollment to the end of treatment at 8 weeks
Change in luteinizing hormone (LH) levels
Time frame: From enrollment to the end of treatment at 8 weeks
Change in quality of life
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 38172876Hariri Z, Yari Z, Hoseini S, Abhari K, Sohrab G. Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial. BMC Womens Health. 2024 Jan 3;24(1):19. doi: 10.1186/s12905-023-02868-1.
- BackgroundKoyutürk, G., & Külünkoğlu, B. A. (2023). Polikistik Over Sendromu Yaşam Kalitesi-50 Ölçeği'nin Türkçe uyarlamasının geçerlik ve güvenirliği. Sağlık ve Yaşam Bilimleri Dergisi, 5(2), 63-70.
- 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.
Derya Sivri-Aydın study director
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Supplement in people with PCOS (Polycystic Ovary Syndrome), run by Atlas 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Emirhuseyinoglu-Calik (+905315239218, ayse.emirhuseyinoglu@atlas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: From enrollment to the end of treatment at 8 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 NCT07342946, 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 28 Oct 2026.