The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome

Официальное название

Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Synbiotic Supplement
  Participants in this arm will receive a hypocaloric Mediterranean diet in addition to synbiotic supplementation for a period of 8 weeks.
• Другое Placebo
  Participants in this arm will receive a hypocaloric Mediterranean diet in addition to a placebo for a period of 8 weeks.

Первичные конечные точки

• Change in body weight [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in body mass index (BMI) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in body composition [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in waist circumference [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in hip circumference [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (6)

• Change in insulin resistance (HOMA-IR) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in fasting blood glucose [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in lipid profile [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in follicle-stimulating hormone (FSH) levels [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in luteinizing hormone (LH) levels [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Change in quality of life [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 38172876
• 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.

Идентификаторы

NCT: NCT07342946 · E-22686390-050.99-78501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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