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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks. |
|
| Synbiotics | Active Comparator | Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synbiotic Supplement | Dietary Supplement | Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
No underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AyÅŸenur Emirhuseyinoglu-Calik | Contact | +905315239218 | ayse.emirhuseyinoglu@atlas.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Derya Sivri-Aydın | Atlas University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38172876 | Background | 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. | |
| Background | Koyutürk, 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. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Placebo | Other | Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks. |
|
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| 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. | 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. | 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. | 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. | 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. | From enrollment to the end of treatment at 8 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |