Differential bone calcium retention with the use of oral versus vaginal hormonal contraception: A randomized trial using calcium-41 radiotracer.

Objectives: This study aimed to assess if hormonal contraception administered orally (combined oral contraceptive pill, COC) or vaginally (contraceptive vaginal ring) differentially affected bone calcium retention in young females.

Study Design: Reproductive aged females (18-35 years) not using hormonal contraception were dosed with 50 nCi Ca as CaCl in 10 mL of sterile saline (0.9%).

Interrelationships between stress, eating attitudes, and metabolism in endurance athletes across a competitive season.

A competitive sport season represents a multidimensional stressor where physical and psychological stress may render an athlete susceptible to energy deficiency (ED). Downstream effects of ED can include a reduction in measured-to-predicted resting metabolic rate (RMR), indicating metabolic compensation. A pathway linking stress, eating attitudes, and metabolic compensation has not been explored.

Gut microbes differ in postmenopausal women responding to prunes to maintain hip bone mineral density.

Foods high in phenolics such as prunes have been shown to exert protective effects on bone mineral density (BMD), but only certain individuals experience these benefits. This analysis of a 12-month randomized controlled trial aimed to identify the relationship among the gut microbiome, immune responses, and bone protective effects of prunes on postmenopausal women. Subjects who consumed 50-100 g prunes daily were divided into responders ( = 20) and non-responders ( = 32) based on percent change in total hip bone mineral density (BMD, ≥1% or ≤-1% change, respectively).

Effects of Prune (Dried Plum) Supplementation on Cardiometabolic Health in Postmenopausal Women: An Ancillary Analysis of a 12-Month Randomized Controlled Trial, The Prune Study.

Background: Estrogen withdrawal during menopause is associated with an unfavorable cardiometabolic profile. Prunes (dried plums) represent an emerging functional food and have been previously demonstrated to improve bone health. However, our understanding of the effects of daily prune intake on cardiometabolic risk factors in postmenopausal women is limited.

Prunes preserve cortical density and estimated strength of the tibia in a 12-month randomized controlled trial in postmenopausal women: The Prune Study.

Unlabelled: Non-pharmacological therapies, such as whole-food interventions, are gaining interest as potential approaches to prevent and/or treat low bone mineral density (BMD) in postmenopausal women. Previously, prune consumption preserved two-dimensional BMD at the total hip. Here we demonstrate that prune consumption preserved three-dimensional BMD and estimated strength at the tibia.

Are menstrual disturbances associated with an energy availability threshold? A critical review of the evidence.

Exercising women have a high prevalence of menstrual disturbances. In 2003, it was suggested that disruption in luteinizing hormone (LH) pulsatility occurs below a threshold of energy availability (EA) of 30 kcal/kg lean body mass (LBM)/day. This paper is a critical review of the evidence regarding the theory that disruptions to the reproductive axis and menstrual disturbances occur below the proposed threshold.

Prune Consumption Attenuates Proinflammatory Cytokine Secretion and Alters Monocyte Activation in Postmenopausal Women: Secondary Outcome Analysis of a 12-Mo Randomized Controlled Trial: The Prune Study.

Background: Proinflammatory cytokines are implicated in the pathophysiology of postmenopausal bone loss. Clinical studies demonstrate that prunes prevent bone mineral density loss; however, the mechanism underlying this effect is unknown.

Objective: We investigated the effect of prune supplementation on immune, inflammatory, and oxidative stress markers.

Exercise training modifies the bone and endocrine response to graded reductions in energy availability in skeletally mature female rodents.

Introduction: Reductions in energy availability leading to weight loss can induce loss of bone and impact important endocrine regulators of bone integrity. We sought to elucidate whether endurance exercise (EX) can mitigate bone loss observed in sedentary (SED) skeletally mature rodents subjected to graded energy deficits.

Methods: Female virgin rats (n=84, 5-mo-old; 12/group) were randomized to baseline controls and either sedentary (SED) or exercise (EX) conditions, and within each exercise status to adlib-fed (ADLIB), or moderate (MOD) or severe (SEV) energy restriction diets for 12 weeks.

The Influence of Energy Balance and Availability on Resting Metabolic Rate: Implications for Assessment and Future Research Directions.

Resting metabolic rate (RMR) is a significant contributor to an individual's total energy expenditure. As such, RMR plays an important role in body weight regulation across populations ranging from inactive individuals to athletes. In addition, RMR may also be used to screen for low energy availability and energy deficiency in athletes, and thus may be useful in identifying individuals at risk for the deleterious consequences of chronic energy deficiency.

12-months of increased dietary intake does not exacerbate disordered eating-related attitudes, stress, or depressive symptoms in women with exercise-associated menstrual disturbances: The REFUEL randomized controlled trial.

Unlabelled: Disordered eating-related attitudes are a leading cause of energy deficiency and menstrual disturbances in exercising women. Although treatment recommendations include psychological counseling with increases in dietary intake, a key concern is whether increased dietary intake may exacerbate negative eating behaviors.

Objective: To determine the effects of a 12-month nutritional intervention on eating-related attitudes and psychological characteristics in exercising women with oligomenorrhea/amenorrhea (Oligo/Amen).

Associations Between Inflammatory Mediators and Bone Outcomes in Postmenopausal Women: A Cross-Sectional Analysis of Baseline Data from the Prune Study.

Purpose: Hypoestrogenism triggers increased production of inflammatory mediators, which contribute to bone loss during postmenopausal osteoporosis. This study aimed to investigate the association between circulating inflammatory markers and bone outcomes in postmenopausal women.

Materials And Methods: We conducted a cross-sectional, secondary analysis of baseline data from participants who completed a 12-month randomized controlled trial, The Prune Study (NCT02822378), which included healthy postmenopausal women (n=183, 55-75 years old) with bone mineral density (BMD) T-score between 0.

Effects of rifampin on the pharmacokinetics and pharmacodynamics of milvexian, a potent, selective, oral small molecule factor XIa inhibitor.

Milvexian (BMS-986177/JNJ-70033093) is a potent, oral small molecule that inhibits the active form of factor XI with high affinity and selectivity. This study assessed the single-dose pharmacokinetic and pharmacodynamic properties of milvexian co-administered with rifampin, an organic anion transport protein (OATP) inhibitor and potent cytochrome P450 (CYP) 3A and P-glycoprotein (P-gp) inducer. In this open-label, nonrandomized, single-sequence study, healthy participants (N = 16) received single doses of milvexian on Day 1 (100 mg), milvexian and rifampin (600 mg) on Day 4, rifampin on Days 5-11, milvexian and rifampin on Day 12, and rifampin on Days 13-14.

Prune supplementation for 12 months alters the gut microbiome in postmenopausal women.

Prunes have health benefits, particularly in postmenopausal women. It is likely that the gut microbiome mediates some of these effects, but its exact role remains to be elucidated. This study aims to characterize the effect of prune supplementation on the gut microbiome of postmenopausal women.

Sex differences and indications of metabolic compensation in within-day energy balance in elite Division 1 swimmers.

To determine whether mismatched energy intake and expenditure across the day and associated sex differences may be related with metabolic compensation and/or negative health outcomes, we assessed total-day and hourly energy balance (TDEB and EB), total-day and hourly energy intake (TDEI and EI), total-day and hourly energy expenditure (TDEE and EE) and within-day energy balance (WDEB) in elite male and female swimmers ( = 25; 18-22 years). Total triiodothyronine (TT), resting metabolic rate (RMR), and the ratio of actual-to-predicted RMR were determined. Males exhibited higher TDEB (+758 ± 702 kcal vs +52 ± 505 kcal, -test;  = 0.

Association of diet quality and hormonal status in exercising women with menstrual disturbances.

Diet plays a role in the pathophysiology and treatment of women with hyperandrogenic menstrual disturbances; however, limited research exists examining components of dietary intake in women with subclinical menstrual disturbances. The aim of this investigation was to evaluate the relationship between diet quality and hormonal status in exercising women with menstrual disturbances. Eighty exercising women with ovulatory menstrual cycles (OV;  = 32), women with oligo/amenorrhea without evidence of hyperandrogenism (Oligo/Amen-LowFAI;  = 28), and women with oligo/amenorrhea and evidence of subclinical hyperandrogenism (Oligo/Amen-HighFAI;  = 32) participated in the cross-sectional observational study (Clinical Trial Number: NCT00392873).

Prunes preserve hip bone mineral density in a 12-month randomized controlled trial in postmenopausal women: the Prune Study.

Background: Dietary consumption of prunes has favorable impacts on bone health, but more research is necessary to improve upon study designs and refine our understandings.

Objectives: We evaluated the effects of prunes (50 g or 100 g/d) on bone mineral density (BMD) in postmenopausal women during a 12-mo dietary intervention. Secondary outcomes include effects on bone biomarkers.

New oral protease-activated receptor 4 antagonist BMS-986120: tolerability, pharmacokinetics, pharmacodynamics, and gene variant effects in humans.

BMS-986120 is a novel first-in-class oral protease-activated receptor 4 (PAR4) antagonist exhibiting robust antithrombotic activity that has shown low bleeding risk in monkeys. We sought to assess pharmacokinetics, pharmacodynamics, and tolerability of BMS-986120 in healthy participants and platelet responses to BMS-986120 in participants carrying PAR4 A120T variants. Phase I, randomized, double-blind, placebo-controlled single-ascending-dose (SAD; N = 56) and multiple-ascending-dose (MAD; N = 32) studies were conducted.

Moderate Weight Loss is associated with Reductions in LH Pulse Frequency and Increases in 24-hour Cortisol with no change in Perceived Stress in Young Ovulatory Women.

Objective: Determine the potential role of cortisol as an indicator of both metabolic and psychosocial stress and its relation to LH pulse dynamics during a three-month diet and exercise intervention causing moderate weight loss.

Methods: Secondary analysis of a randomized controlled trial that demonstrated the causal role of low energy availability in the disruption of the menstrual cycle. Twenty-one women aged 18-24 yrs (BMI 21.

Rationale and study design of Randomized Controlled Trial of Dietary Supplementation with prune (dried plums) on bone density, geometry, and estimated bone strength in postmenopausal women: The Prune study.

The use of non-pharmacological alternatives to pharmacological interventions, e.g., nutritional therapy, to improve or maintain bone mineral density (BMD) in postmenopausal women has gained traction over the past decade, but limited data exist regarding its efficacy.

Effects of Itraconazole and Diltiazem on the Pharmacokinetics and Pharmacodynamics of Milvexian, A Factor XIa Inhibitor.

Introduction: Modulation of Factor XIa (FXIa) may provide a novel mechanism for systemic anticoagulation with the potential to improve the risk-benefit profile observed with existing anticoagulants through greater efficacy or a safer bleeding profile. This study assessed the effects of co-administration with strong and moderate CYP3A inhibitors itraconazole and diltiazem, respectively, on the pharmacokinetic and pharmacodynamic properties of milvexian, a Factor XIa inhibitor.

Methods: This was an open-label, non-randomized, two-period crossover study in healthy participants.

Safety, pharmacokinetics, and pharmacodynamics of milvexian in healthy Japanese participants.

This randomized, double-blind, placebo-controlled, multiple ascending-dose study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of milvexian, an oral small-molecule FXIa inhibitor, in healthy Japanese participants. Participants received oral milvexian daily under fasted (50 mg and 200 mg) or fed conditions (500 mg) or placebo over 14 days; 24 participants (8/cohort: 6 milvexian; 2 placebo) were planned. Due to an unblinding event, participants in one cohort (200 mg daily) were discontinued, and a second cohort enrolled; 32 participants were included in safety and pharmacodynamic analyses, and 24/32 in pharmacokinetic analyses.

Bone mineral density in response to increased energy intake in exercising women with oligomenorrhea/amenorrhea: the REFUEL randomized controlled trial.

Background: Energy deficiency can result in menstrual disturbances and compromised bone health in women, a condition known as the Female Athlete Triad.

Objectives: The REFUEL randomized controlled trial assessed the impact of increased energy intake on bone health and menstrual function in exercising women with menstrual disturbances.

Methods: Exercising women with oligomenorrhea/amenorrhea (Oligo/Amen) were randomly assigned to an intervention group (Oligo/Amen + Cal, n = 40, mean ± SEM age: 21.

The Role of Prunes in Modulating Inflammatory Pathways to Improve Bone Health in Postmenopausal Women.

The prevalence of osteoporosis among women aged 50 y and older is expected to reach 13.6 million by 2030. Alternative nonpharmaceutical agents for osteoporosis, including nutritional interventions, are becoming increasingly popular.

The Deposition of a Lectin from on the Surface of Titanium Dioxide Nanotubes Improved the Cell Adhesion, Proliferation, and Osteogenic Activity of Osteoblast-like Cells.

Titanium and its alloys are used as biomaterials for medical and dental applications, due to their mechanical and physical properties. Surface modifications of titanium with bioactive molecules can increase the osseointegration by improving the interface between the bone and implant. In this work, titanium dioxide nanotubes (TiONTs) were functionalized with a lectin from the plasma of the fish aiming to favor the adhesion and proliferation of osteoblast-like cells, improving its biocompatibility.