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The long-term goal of our ongoing studies is to determine if, and to what extent, a multi-mineral product (Aquamin) could benefit individuals with ulcerative colitis (UC). As a step toward achieving that goal, we carried out a pilot 180-day biomarker trial (clinicaltrials.gov ID: NCT03869905) in patients with UC in remission or with mild disease. A total of 28 subjects participated in the study. Each subject was randomly assigned to receive either Aquamin for 180 days or placebo for 90 days. At Day-90, placebo subjects crossed over to Aquamin for the final 90 days. At Day-0, -90 and -180, serum samples were analyzed for C-reactive protein (CRP), alkaline phosphatase (ALP), intestine-specific ALP (ALPI), and for biomarkers of bone turnover (osteocalcin, TRAP5b and bone-specific ALP [BALP]). Stool specimens were assessed for fecal calprotectin (fCAL) and colon biopsies were examined histologically by Geboes scoring at the same time points. Each subject underwent DEXA scanning (at Day-0 and Day-180 only). In addition, mass spectrometry-based proteomic assessment was performed using colon biopsies obtained at each time point. Subjects who received Aquamin for the complete 180-day period (a total of 12) demonstrated improvements in all biomarkers (CRP, fCAL, ALP, ALPI, and Geboes scoring); this was not observed in the placebo group (16 subjects). When cumulative pre-post differences were compared between the Aquamin and placebo groups, Aquamin treatment significantly decreased these differences (a 24% decrease as compared to a 38% increase with placebo, p = 0.0284). Subjects who received Aquamin for 90-days showed intermediary responses. Subjects receiving Aquamin for 180 days also demonstrated increases in bone mineral density (BMD) and bone mineral content (BMC), resulting in a statistically significant increase (7.3%, p = 0.0324) in the hip strength index over the treatment period. This was accompanied by increases in osteocalcin and TRAP5b and a decrease in BALP. The proteomic screen demonstrated upregulation of multiple gut barrier proteins, cell surface transporter molecules and certain proteins with anti-inflammatory potential in response to Aquamin. Aquamin treatment also led to downregulation of several proteins associated with the pro-inflammatory state. The results presented here suggest that the use of a multi-mineral intervention improves disease-related biomarkers in patients with UC. These studies suggest the potential value of the mineral intervention as a low-cost, non-toxic adjuvant therapy for mild UC or for individuals with UC in remission.

Mini-abstract The aim of the current study was to examine the effects of light- to moderate intensity aerobic exercise on bone mineral density (BMD) in postmenopausal osteopenic women by using bone formation and resorption markers. In the current study, P1NP and CTX levels increased in both the exercise and the control group. Summary The aim of the current study was to examine the effects of light- to moderate-intensity aerobic exercise on bone mineral density (BMD) in postmenopausal osteopenic women by using rapidly responsive bone formation and resorption markers. Purpose In this prospective, randomized, controlled, single-blind clinical study, women aged 45–65 years with BMD T scores between − 1 and − 2.5 measured by double X-ray absorptiometry (DXA) were included after evaluation of exclusion criteria and the women were divided into 2 groups: aerobic exercise group and control group (exercise, n  = 25; control, n  = 25). At baseline and at the 12-week follow-up, the serum levels of bone formation and resorption biomarkers, including procollagen type 1 N-terminal propeptide (P1NP), cross-linked C-telopeptide of type I collagen (CTX), osteocalcin, oxidative markers such as malondialdehyde, nonbone-specific total alkaline phosphatase, 25(OH)D3, and parathyroid hormone (PTH), were examined in all patients. Results A statistically significant increase in P1NP and CTX levels was noted in both the exercise and control groups at the 12-week evaluation compared to baseline ( p  > 0.05). Although there was no significant change in osteocalcin levels in the control group ( p  > 0.05), a statistically significant increase was observed in the exercise group ( p  < 0.05). In the exercise group, no significant changes were observed in bone formation or resorption markers, including P1NP, CTX, osteocalcin, and total ALP, or in oxidative stress markers, such as malondialdehyde, compared to those in the control group ( p  > 0.05). Conclusion In conclusion, the current study revealed that regular walking exercise of light to moderate intensity significantly contributes to improvements in pain, walking speed, balance, lower extremity dynamic balance, and activities of daily living in postmenopausal women with osteopenia compared to inactive individuals. Trial registration Clinical Trial Number NCT06866561.

Milk products are good sources of calcium that may reduce bone resorption and help prevent bone loss as well as promote bone remodeling and increase bone formation. Kefir is a product made by kefir grains that degrade milk proteins into various peptides with health-promoting effects, including antithrombotic, antimicrobial and calcium-absorption enhancing bioactivities. In a controlled, parallel, double-blind intervention study over 6 months, we investigated the effects of kefir-fermented milk (1,600 mg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. Bone mineral density (BMD) values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months. Among patients treated with kefir-fermented milk, the relationships between baseline turnover and 6 months changes in DXA-determined BMD were significantly improved. The serum β C-terminal telopeptide of type I collagen (β-CTX) in those with T-scores > -1 patients significantly decreased after three months treatment. The formation marker serum osteocalcin (OC) turned from negative to positive after 6 months, representing the effect of kefir treatment. Serum parathyroid hormone (PTH) increased significantly after treatment with kefir, but decreased significantly in the control group. PTH may promote bone remodeling after treatment with kefir for 6 months. In this pilot study, we concluded that kefir-fermented milk therapy was associated with short-term changes in turnover and greater 6-month increases in hip BMD among osteoporotic patients. ClinicalTrials.gov NCT02361372.

Background/Objectives:Vitamin K status has been linked to fat and glucose metabolism by several authors, but whether high vitamin K intake influences body weight or composition has remained unclear. Here we tested the hypothesis that increased vitamin K intake decreases body fat or fat distribution.Subjects/Methods:In a randomized placebo-controlled human intervention trial, 214 postmenopausal women, 55-65 years of age, received either 180 mcg/day of vitamin K2 (menaquinone-7, MK-7) or placebo for 3 years. Osteocalcin (OC) carboxylation was used as a marker for vitamin K status, and fat distribution was assessed by dual-energy X-ray absorptiometry total body scan.Results:In the total cohort, MK-7 supplementation increased circulating carboxylated OC (cOC) but had no effect on body composition. In those with an above-median response in OC carboxylation ('good responders'), MK-7 treatment resulted in a significant increase in total and human molecular weight adiponectin and a decrease in abdominal fat mass and in the estimated visceral adipose tissue area compared with the placebo group and the poor responders.Conclusions:The fact that changes in body composition measures or markers for fat or glucose metabolism were not associated with changes in uncarboxylated OC (ucOC) does not support the assumption that ucOC stimulates fat metabolism in humans. Instead, high vitamin K2 intake may support reducing body weight, abdominal and visceral fat, notably in subjects showing a strong increase in cOC. A causal relation between the changes in cOC and body fat or distribution cannot be concluded from these data.

Brain energy metabolism disorders, including glucose utilization disorders and abnormal insulin sensitivity, are linked to the pathogenesis of postoperative delirium. Intranasal insulin has shown significant benefits in improving glucose metabolism, insulin sensitivity and cognitive function. However, its impact on postoperative delirium and insulin sensitivity biomarkers remains unknown. This randomized, double-blind, placebo-controlled trial was to evaluate whether intranasal insulin reduces the incidence and severity of postoperative delirium (POD) in older patients undergoing joint replacement, and its effect on insulin sensitivity-related biomarkers. 212 older patients (≥65 years) were randomly assigned to receive either 40 IU of intranasal insulin (n=106) or a placebo (n=106) for 8 days. The primary objective was to determine the incidence and severity of POD within 5 days after surgery, estimated using the Confusion Assessment Method (CAM) and the Delirium Rating Scale (DRS)-98. The secondary objective was insulin sensitivity, which was assessed using the homeostasis model Assessment of Insulin Resistance (HOMA-IR) and biomarkers, including total osteocalcin (tOC), uncarboxylated osteocalcin (ucOC), and brain-derived neurotrophic factor (BDNF). Compared to placebo, intranasal insulin significantly reduced the incidence of delirium within 5 days after surgery (8 [8.33%] vs 23 [23.23%], P = 0.004, odds ratio [OR] = 3.33 [95% CI 1.41-7.88]) and the severity of delirium (P<0.001). Intranasal insulin elevated the levels of tOC, ucOC, and BDNF in the CSF on D (all P<0.001) and tOC levels in the plasma on D , D and D (all P<0.001). It elevated ucOC levels in the plasma of the insulin group on D but not on D and D (all P<0.001). Intranasal insulin administration reduced the HOMA-IR on D (P=0.002). Intranasal insulin notably reduced the incidence and severity of POD in older patients undergoing joint replacement, which may be related to the elevation in osteocalcin and BDNF levels. Chinese Clinical Trial Registry (ChiCTR2300068073).

Background/Objective: In patients with acute lymphoblastic leukemia (ALL), it has been demonstrated that the treatment has a negative effect on bone health. The n-3 polyunsaturated fatty acids (LCPUFAs-ω3) may attenuate bone resorption. We evaluated the effects of LCPUFAs-ω3, vitamin D, and calcium supplementation on bone turnover markers and changes in vitamin D concentrations during 6 weeks of supplementation and during 6 weeks of post-intervention follow-up in pediatric patients with ALL. Methods: Thirty-six pediatric patients with ALL were randomly assigned to the ω-3VDCa group (100 mg/kg/d LCPUFAs-ω3 + 4000 IU vitamin D + 1000 mg calcium) or the VDCa group (4000 IU vitamin D + 1000 mg calcium) for 6 weeks. Blood samples were collected to determine 25(OH)D, PTH, ICTP, and TRAP-5b (biomarkers of bone resorption) and osteocalcin (OC, a biomarker of bone production) levels at baseline, 6 weeks, and 12 weeks after supplementation. The 25(OH)D analysis was performed using ultra-high-performance liquid chromatography coupled to a mass spectrometer, and PTH and bone turnover markers were measured by ELISA. Results: The 25(OH)D concentration increased in both groups (ω3VDCa group: 19.4 ng/mL vs. 44.0 ng/mL, p < 0.0001; VDCa group: 15.3 ng/mL vs. 42.8 ng/mL, p = 0.018) and remained significantly higher at 12 weeks. At 12 weeks, ICTP showed lower concentrations in the ω-3VDCa group than in the VDCa group (0.74 ng/mL vs. 1.05 ng/mL, p = 0.024). Conclusions: Combined omega-3 and 4000 IU vitamin D supplementation for 6 weeks had a positive effect on bone health, as indicated by serum ICTP, with no effect on serum 25(OH)D levels over vitamin D supplementation alone.

Osteoporosis is a major health concern in aging populations, where 54% of the U.S. population aged 50 and older have low bone mineral density (BMD). Increases in inflammation and oxidative stress play a major role in the development of osteoporosis. Men are at a greater risk of mortality due to osteoporosis-related fractures. Our earlier findings in rodent male and female models of osteoporosis, as well as postmenopausal women strongly suggest the efficacy of prunes (dried plum) in reducing inflammation and preventing/reversing bone loss. The objective of this study was to examine the effects of two doses of prunes, daily, on biomarkers of inflammation and bone metabolism in men with some degree of bone loss (BMD; t-score between −0.1 and −2.5 SD), for three months. Thirty-five men between the ages of 55 and 80 years were randomized into one of three groups: 100 g prunes, 50 g prunes, or control. Consumption of 100 g prunes led to a significant decrease in serum osteocalcin (p < 0.001). Consumption of 50 g prunes led to significant decreases in serum osteoprotegerin (OPG) (p = 0.003) and serum osteocalcin (p = 0.040), and an increase in the OPG:RANKL ratio (p = 0.041). Regular consumption of either 100 g or 50 g prunes for three months may positively affect bone turnover.

Hypothalamic amenorrhea may be accompanied by low leptin levels. These investigators administered recombinant human leptin to eight women with hypothalamic amenorrhea. Six additional untreated subjects served as historical controls. Treatment with recombinant leptin increased mean luteinizing hormone levels and pulse frequency, improved ovarian variables, and resulted in ovulation in three women and in withdrawal bleeding in two. Leptin administration may improve reproductive, thyroid, and growth hormone function. Hypothalamic amenorrhea, either organic or functional, 1 is characterized by the absence of menstrual cycles, low estrogen levels, and low or normal levels of gonadotropins. It accounts for over 30 percent of cases of amenorrhea in women of reproductive age 2 and may lead to infertility and bone loss. 3 Functional hypothalamic amenorrhea occurs when a relative energy deficit (owing to weight loss, excessive exercise, or eating disorders) disrupts the secretion of hypothalamic gonadotropin-releasing hormone (GnRH) and other neuroendocrine axes. 4 – 7 However, the precise signal or signals indicating the availability of energy remain unknown. Leptin, a hormone secreted by adipocytes that regulates energy . . .

Impaired iron metabolism is associated with increased risk of many morbidities. Exercise was shown to have a beneficial role; however, the mechanism is not well understood. The purpose of this study was to assess the relationship between exerkines and iron metabolism in elderly women before and after 12 weeks of Nordic Walking (NW) training. Exerkines like myostatin, adiponectin, and osteocalcin have been shown to have several positive effects on metabolism. Thirty-six post-menopausal women (66 ± 5 years old, mean ± SD) were randomly assigned to a NW intervention group (n = 18; body mass, 68.8 ± 11.37 kg; fat, 23.43 ± 7.5 kg; free fat mass, 45.37 ± 5.92 kg) or a control group (n = 18; body mass, 68.34 ± 11.81 kg; fat, 23.61 ± 10.03 kg; free fat mass, 44.73 ± 3.9 kg). The training was performed three times a week for 12 weeks, with the intensity adjusted to 70% of the individual maximum ability. Before and one day after the 12-weeks intervention, performance indices were assessed using a senior fitness test. Blood samples (5 mL) were obtained from the participants between 7 and 8 AM, following an overnight fast, at baseline and one day immediately after the 12-week training program. A significant and large time × group interaction was observed for iron (NW: 98.6 ± 26.68 to 76.1 ± 15.31; CON: 100.6 ± 25.37 to 99.1 ± 27.2; p = 0.01; η p 2 = 0.21), myostatin (NW: 4.42 ± 1.97 to 3.83 ± 1.52; CON: 4.11 ± 0.95 to 4.84 ± 1.19; p = 0.00; η p 2 = 0.62), adiponectin (NW: 12.0 ± 9.46 to 14.6 ± 10.64; CON: 12.8 ± 8.99 to 11.9 ± 8.53; p = 0.00; η p 2 = 0.58), and osteocalcin (NW: 38.9 ± 26.04 to 41.6 ± 25.09; CON: 37.1 ± 33.2 to 37.2 ± 32.29; p = 0.03; η p 2 = 0.13). Furthermore, we have observed the correlations: basal ferritin levels were inversely correlated with changes in myostatin (r = −0.51, p = 0.05), change in adiponectin, and change in serum iron (r = −0.45, p = 0.05), basal iron, and osteocalcin after training (r = -0.55, p = 0.04). These findings indicate that iron modulates NW training-induced changes in exerkine levels.

Vitamin K is required for the carboxylation of Gla-proteins in the liver (coagulation factors) and extra-hepatic tissues, such as bone (osteocalcin, OC), and arterial wall (matrix Gla-protein, MGP). Although the coagulation factors are essentially fully carboxylated under normal conditions, 10–40 % of OC and MGP remains undercarboxylated. We were therefore interested to study the dose–response effects of extra intake of menaquinones on the carboxylation of the extra-hepatic Gla-proteins. A total of forty-two healthy Dutch men and women aged between 18 and 45 years were randomised into seven groups to receive: placebo capsules or menaquinone-7 (MK-7) capsules at a daily dose of 10, 20, 45, 90, 180 or 360 μg. Circulating uncarboxylated OC (ucOC), carboxylated OC (cOC) and desphospho-uncarboxylated MGP were measured by ELISA. The ucOC:cOC ratio was calculated from circulating ucOC and cOC values. Endogenous thrombin potential and peak height were determined by calibrated automated thrombography. To increase the statistical power, we collapsed the treatment groups into three dosage groups: placebo, low-dose supplementation (doses below RDA, Commission Directive 2008/100/EC), and high-dose supplementation (doses around RDA, Commission Directive 2008/100/EC). MK-7 supplementation at doses in the order of the RDA (Commission Directive 2008/100/EC) increased the carboxylation of circulating OC and MGP. No adverse effects on thrombin generation were observed. Extra MK-7 intake at nutritional doses around the RDA (Commission Directive 2008/100/EC) improved the carboxylation of the extra-hepatic vitamin K-dependent proteins. Whether this improvement contributes to public health, i.e. increasing the protection against age-related diseases needs further investigation in specifically designed intervention trials.