Acceptability, adherence and feasibility of a Mediterranean diet intervention on anthropometric, biochemical and hormonal parameters in women with Polycystic Ovary Syndrome

Nicole Scannell

doi:10.25907/01096

Polycystic Ovary Syndrome (PCOS) affects approximately 13% of women of reproductive age and has extensive physiological and psychological consequences. A healthy diet is considered first-line treatment for managing PCOS, yet no specific therapeutic dietary interventions, beyond standard population-based guidelines, have been identified. Many women with PCOS also seek nutraceutical and micronutrient supplementation as adjunct therapies for management of PCOS symptoms. However, due to the lack of evidence, no clear recommendations exist regarding their use. Given the interest in novel dietary approaches, a Mediterranean diet (MedDiet) may offer potential benefits for women with PCOS by improving cardiometabolic, reproductive, and psychological outcomes. The primary aim of this thesis was to investigate the acceptability, adherence and feasibility of a MedDiet intervention for the management of anthropometric, biochemical and hormonal parameters of PCOS. The secondary aim was to identify the most commonly studied micronutrient and nutraceutical supplements with regard to PCOS related outcomes. To achieve these study aims, this thesis employs a combination of reviews and a randomised controlled trial (RCT) using a mixed methods approach. The Scoping Review systematically mapped the literature to date for the use of nutraceutical and micronutrient supplementation in PCOS symptom management. A comprehensive search identified 344 studies, covering 41 different supplements, with inositols (n = 86), vitamin D (n = 53), N-acetylcysteine (n = 27), and omega-3 fatty acids (n = 25) being the most frequently investigated. The most reported outcomes were reproductive (83%), followed by metabolic (67%), anthropometric (57%), and psychological (2%). These findings highlight a paucity of studies to elicit psychological outcomes and the need for adequately powered RCTs to establish therapeutic doses, efficacy and safety to inform clinical recommendations. The Literature Review reviewed the potential role of a MedDiet for the therapeutic management of PCOS-related health outcomes, including cardiometabolic, reproductive, and psychological features. Observational evidence suggests there is an inverse relationship between MedDiet adherence and PCOS features, particularly insulin resistance and hyperandrogenemia. These benefits are likely mediated by the anti-inflammatory properties and the bioactive compounds present within a MedDiet, including carotenoids, polyphenols, and omega-3 polyunsaturated fatty acids (PUFAs). While results from this review were positive, gaps in the literature were identified including the need for RCTs to evaluate the acceptability, feasibility, and efficacy of a MedDiet intervention for PCOS management. The Study Protocol developed a protocol for a 12-week pilot RCT to investigate the efficacy of a MedDiet intervention on anthropometric, biochemical and hormonal parameters in women with PCOS. The study aimed to assess both clinical outcomes and the acceptability and feasibility of an ad libitum MedDiet. Eligible women with PCOS and a BMI ≥ 25 kg/m² (aged 18 - 45 years) were randomised to either an ad libitum MedDiet intervention or a Healthy Eating intervention (control) based on dietary advice consistent with the Australian Dietary Guidelines. Participants would receive fortnightly counselling to facilitate behaviour change. Key outcome measures included changes in insulin resistance, glucose levels, total testosterone, sex hormone-binding globulin, body weight and waist circumference. An evaluation of participants’ adherence, the lived experiences for those participants randomised to the MedDiet intervention and feasibility was also explored. This study provided a protocol which aimed to identify critical insights of dietary strategies for PCOS management. Study 1 examined adherence and the lived experiences of participants randomised to the MedDiet group of the RCT. Ten women (BMI ≥ 25 kg/m²) completed the 12- week intervention, with adherence significantly improving from baseline (4.1 ± 1.85) to week 12 (8.3 ± 2.31; P = 0.001). Significant improvements were also observed in nutrition knowledge (P = 0.004), cooking confidence (P = 0.01), and time management (P = 0.01). Guided by the Capability, Opportunity, Motivation- Behaviour (COM-B) model, semi-structured interviews identified influencers to MedDiet adherence, that were mapped across 12 of the 14 domains of the Theoretical Domains Framework (TDF). Facilitators included perceived health benefits, reduced pressure to lose weight, improved knowledge, and simple dietary guidelines. Barriers included difficulties with food preparation, food availability, and external influences. Integration of these findings and subsequent mapping to the Behaviour Change Wheel (BCW) highlighted the need for MedDiet education, behaviour change support, practical resources, and professional training for healthcare providers. These strategies could facilitate the implementation of the MedDiet as a dietary management approach for women with PCOS. Study 2 investigated the feasibility of the pilot RCT and evaluated aspects including participant recruitment and retention and preliminary efficacy. Twenty-six women with PCOS (BMI ≥ 25 kg/m²) were randomised to follow either an ad libitum MedDiet intervention (n = 12) or an ad libitum Healthy Eating (control) intervention (n = 14). The study identified a significantly higher attrition rate in the control and challenges to recruitment. Key recommendations for future research include addressing barriers to recruitment and expansion of the inclusion criteria. Findings suggest that women with PCOS prefer personalised, novel dietary interventions over standard population guidelines. Future studies should consider expanding the inclusion criteria to help facilitate adequately powered studies.

Acceptability, adherence and feasibility of a Mediterranean diet intervention on anthropometric, biochemical and hormonal parameters in women with Polycystic Ovary Syndrome

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