Nutrients 2023 , 15 , 2688
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between 18–32 kg/m 2 , and presenting with osteopenia defined as a dual energy X-ray absorptiometry (DXA) T-score between − 1and − 2.5 (based on the lowest T-score at any site). Exclusion criteria included osteoporosis (i.e., T-score ≤− 2.5), currently taking or had taken within the previous three months any drug for osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate, or denosumab) or any treatment with estrogen or hormone therapy or estrogen agonist/antagonist products (raloxifene or tamoxifene), had taken antibiotics or laxatives during the preceding 2 months, or had experienced gastroenteritis or foodborne illness within 4 weeks prior to the study. Participants had to be healthy, i.e., without uncontrolled hypertension, hypothyroidism, or hyperthyroidism (or must be on stable medication for at least 3 months), without history of cancer within the last five years (except basal cell carcinoma, non-squamous skin carcinoma, or carcinoma in situ with no significant progression over the past 2 years), and without significant cardiovascu- lar, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude supplement ingestion and/or assessment of safety and the study objectives. Additionally, participants that were currently taking or had taken any vitamin K or isoflavones supplementation within the previous 4 weeks, were hypersensitive to any of the components of the investigational product (IP), were smokers, were exhibiting excess alcohol consumption, or had been trying to lose weight for the last 3 months were also excluded. Participants who gave written informed consent and were deemed eligible at their screening visit were assigned a randomization number in chronological order. The ran- domization 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 (SAS ® Software version 9.4, Cary, NC, USA). All research staff involved in the collection and the analysis of the data remained blinded to the treatment random- ization until all aspects of the study were complete, including the statistical analysis. A total of 50 participants were allocated to the hop extract (HE; 1 capsule per day) group, and 50 participants were allocated to the placebo group (1 capsule per day). Both groups also received calcium and vitamin D (CaD) supplements (2 capsules per day, each capsule consisting of 500 mg of calcium and 400 IU of vitamin D3; manufactured by Pharmavite, Nature Made). Participants were instructed to follow their usual dietary habits and main- tain normal physical activity throughout the study, which was monitored via food and exercise questionnaires (see Section 2.6 below for details). Randomized 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 ClinicalTrials.gov (NCT04004013). 2.2. Study Product Hop extract (HE) standardized in 8-PN (Lifenol ® , Givaudan France Naturals, Avignon, France) or placebo was administrated orally in capsules. Each HE capsule comprised
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