2.1. Study Design and Participants
RECRUITMENT
This study was a 48-week, parallel-design, placebo-controlled, double-blind, randomized clinical trial. The clinical aspects of the study were carried out from August 2019 to December 2020 in Cork (Ireland), including screening, recruitment, and follow-up. Participants were recruited through advertisements (local newspaper and social media platforms) or referred by local general practitioners in the area. A total of 221 participants were screened to identify 100 eligible participants, all of whom were postmenopausal women (>1-year post-menopause), between 50 and 85 years of age, with a body mass index (BMI) between 18–32 kg/mParticipants who gave written informed consent and were deemed eligible at their screening visit were assigned a randomization number in chronological order. The randomization list was generated by an independent biostatistician (Atlanstat, France). A permuted-block, fixed randomization schedule was used with 2 block sizes (the first 14 blocks were size 6 and the next 14 blocks size 4), based on a computer-generated random numbers program (SASRandomized participants were scheduled to attend 5 visits at the research center at baseline (0), 12, 24, 36, and 48 weeks. Anthropometric parameters (height, weight, BMI, waist circumference, and hip circumference), vitals (blood pressure, heart rate, and temperature), quality of life assessed by the 36-item short form (SF-36), and physical activity assessed by the Physical Activity Scale for the Elderly (PASE) were measured at each visit. DXA measurements (BMD at femoral neck, L2–L4, total hip and total body, T-score at femoral neck and L2–L4, FRAX scores and body composition), fecal samples, and blood samples were collected at baseline, at 24 weeks, and at 48 weeks, while urine samples and dietary intake assessed by the food frequency questionnaire (FFQ) were collected at baseline and at 48 weeks only. Due to the COVID-19 pandemic and Irish government restrictions, it was not possible to conduct interim visits (weeks 12, 24, and 36) at the research center. Notably, DXA, anthropometric, and laboratory assessments were either collected on site later or were unable to be collected at these interim visits. The research was conducted under guidelines stated in the current revision of the Declaration of Helsinki, was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals, and was registered at 