Fat-Soluble Vitamins in Standard vs. Liposomal Form Enriched with Vitamin K2 in Cystic Fibrosis: A Randomized Multi-Center Trial.

BACKGROUND: We aimed to assess a liposomal fat-soluble vitamin formulation containing vitamin K2 with standard treatment in cystic fibrosis (CF). METHODS: A multi-center randomized controlled trial was carried out in 100 pancreatic-insufficient patients with CF. The liposomal formulation contained vitamin A as retinyl palmitate (2667 IU daily) and beta-carotene (1333 IU), D3 (4000 IU), E (150 IU), K1 (2 mg), and K2 as menaquinone-7 (400 µg). It was compared with the standard vitamin preparations in the closest possible doses (2500 IU, 1428 IU, 4000 IU, 150 IU, 2.14 mg, respectively; no vitamin K2) over 3 months. RESULTS: Forty-two patients finished the trial in the liposomal and 49 in the control group (overall 91 pts: 22.6 ± 7.6 years, 62.6% female, BMI 19.9 ± 2.8 kg/m2, FEV1% 70% ± 30%). The main outcome was the change of vitamin status in the serum during the study (liposomal vs. standard): all-trans-retinol (+1.48 ± 95.9 vs. -43.1 ± 121.4 ng/mL, p = 0.054), 25-hydroxyvitamin D3 (+9.7 ± 13.4 vs. +2.0 ± 9.8 ng/mL, p = 0.004), α-tocopherol (+1.5 ± 2.5 vs. -0.2 ± 1.6 µg/mL, p < 0.001), %undercarboxylated osteocalcin (-17.2 ± 24.8% vs. -8.3 ± 18.5%, p = 0.061). The secondary outcome was the vitamin status at the trial end: all-trans-retinol (370.0 ± 116.5 vs. 323.1 ± 100.6 ng/mL, p = 0.045), 25-hydroxyvitamin D3 (43.2 ± 16.6 vs. 32.7 ± 11.5 ng/mL, p < 0.001), α-tocopherol (9.0 ± 3.1 vs. 7.7 ± 3.0 µg/mL, p = 0.037), %undercarboxylated osteocalcin (13.0 ± 11.2% vs. 22.7 ± 22.0%, p = 0.008). CONCLUSION: The liposomal fat-soluble vitamin supplement containing vitamin K2 was superior to the standard form in delivering vitamin D3 and E in pancreatic-insufficient patients with CF. The supplement was also more effective in strengthening vitamin K-dependent carboxylation, and could improve vitamin A status.

Comparison of Subjective and Objective Methods to Measure the Physical Activity of Non-Depressed Middle-Aged Healthy Subjects with Normal Cognitive Function and Mild Cognitive Impairment-A Cross-Sectional Study.

This study compared subjective and objective methods of measuring different categories of physical activity in non-depressed middle-aged subjects with normal cognitive function (NCF) and mild cognitive impairment (MCI). In total, 75 participants (NCF: n = 48, MCI: n = 27) were recruited and physical activity was assessed for seven days using the ActiGraph and the International Physical Activity Questionnaire (IPAQ). Anthropometric parameters, body compositions, resting metabolic rate, and energy expenditure were also assessed. ActiGraph data indicated that subjects with NCF were more active than MCI subjects. A comparison of the IPAQ and the ActiGraph data revealed a significant correlation between these methods for total (r = 0.3315, p < 0.01) and moderate (r = 0.3896, p < 0.01) physical activity in the total population and moderate activity (r = 0.2893, p < 0.05) within the NCF group. No associations between these methods were found within the MCI group. Independent predictors of subjectively evaluated total physical activity were alcohol consumption (p = 0.0358) and socio-professional status (p = 0.0288), while weight (p = 0.0285) and the Montreal Cognitive Assessment results (p = 0.0309) were independent predictors of objectively measured physical activity. In conclusion, the long version of IPAQ is a more reliable tool to assess PA in subjects with NCF than those with MCI. More studies are needed to confirm this finding.

Endurance Training Depletes Antioxidant System but Does Not Affect Endothelial Functions in Women with Abdominal Obesity: A Randomized Trial with a Comparison to Endurance-Strength Training.

Limited data suggested that inclusion of a strength component into endurance exercises might intensify the beneficial effect of training. However, the available data is limited. Therefore, we aimed to compare the effect of endurance and endurance-strength training on anthropometric parameters, endothelial function, arterial stiffness, antioxidant status, and inflammatory markers in abdominally obese women without serious comorbidities. A total of 101 women were recruited and randomly divided into endurance (n = 52) and endurance-strength (n = 49) groups. During the three-month intervention, both groups performed supervised sixty-minute training three times a week. All studied parameters were measured pre- and post-intervention period. In total, 85 women completed the study. Both training significantly decreased anthropometric parameters. Besides, endurance training decreased endothelial nitric oxide synthase, central aortic systolic pressure, pulse wave velocity, glutathione (GSH), total antioxidant status (TAS), interleukin (IL) 8, matrix metalloproteinase (MMP) 9, and tumor necrosis factor alpha, while endurance-strength training decreased MMP-2 concentrations, and increased IL-6, monocyte chemoattractant protein-1, and MMP-9 levels. We observed significant differences between groups for GSH, TAS, and MMP-9 levels. In summary, endurance and endurance-strength training did not differ in the impact on endothelial function and arterial stiffness. However, endurance training significantly depleted the antioxidant defense, simultaneously reducing MMP-9 levels. The study was retrospectively registered with the German Clinical Trials Register within the number DRKS00019832.

Body Fat Changes and Liver Safety in Obese and Overweight Women Supplemented with Conjugated Linoleic Acid: A 12-Week Randomised, Double-Blind, Placebo-Controlled Trial.

Preliminary evidence suggests that conjugated linoleic acid (CLA) may reduce body weight and affect body composition. The present study assessed the effect of CLA supplementation on body fat composition in overweight and obese women, while also evaluating the liver safety of CLA use. Seventy-four obese or overweight women were randomly assigned to receive 3 g/day CLA or placebo for 12 weeks. Body composition (dual-energy X-ray absorptiometry) and liver function (13C-methacetin breath test and serum liver enzymes) were assessed before and after the trial. Patients receiving CLA experienced a significant reduction of total body fat expressed as mass (p = 0.0007) and percentage (p = 0.0006), android adipose tissue (p = 0.0002), gynoid adipose tissue (p = 0.0028), and visceral adipose tissue (p = 4.2 × 10-9) as well as a significant increase in lean body mass to height (p = 6.1 × 10-11) when compared to those receiving a placebo. The maximum momentary 13C recovery changes and end-point values were significantly higher in the CLA group when compared to the placebo group (p = 0.0385 and p = 0.0076, respectively). There were no significant changes in alanine aminotransferase, asparagine aminotransferase, and gamma-glutamyl transpeptidase activities between the groups. In conclusion, CLA supplementation was well tolerated and safe for the liver, which shows beneficial effects on fat composition in overweight and obese women.

Lactose intolerance, lactose malabsorption and genetic predisposition to adult-type hypolactasia in patients after restorative proctocolectomy.

This study provides up-to-date findings on lactose malabsorption, lactose intolerance and genetic predisposition to adult-type hypolactasia in 72 patients after restorative proctocolectomy (RPC). The lactose malabsorption was assessed by hydrogen-methane breath test. Genetic predisposition to adult-type hypolactasia was assessed by detecting -13910T/C polymorphism in the lactase gene. Lactose intolerance was more frequent in UC (ulcerative colitis) patients than FAP (familial adenomatous polyposis) patients (77.5% vs. 55.2%; p=0.01). The C/C genotype of the lactase gene was observed in 39.1% subjects with no significant difference between UC and FAP patients. Lactose malabsorption occurred in 10.1% of subjects and almost only in patients with genetic predisposition, with the same frequency in UC and FAP patients.

Cystic fibrosis dyslipidaemia: A cross-sectional study.

BACKGROUND: The interest in cystic fibrosis (CF) dyslipidaemia as a potential risk factor for cardiovascular disease is increasing with patients' survival. This study aimed to investigate CF dyslipidaemia, its clinical correlates and links to oxidized low-density lipoprotein (oxLDL), adiponectin, and apolipoprotein E (APOE). METHODS: This cross-sectional study assessed clinical characteristics of CF, as well as the serum lipid profile, oxLDL, adiponectin, and APOE. RESULTS: In total, 108 CF subjects were enrolled in this study, with a median age of 22 years, BMI of 20.5 kg/m2, FEV1% of 61%, of which 81% were pancreatic insufficient (PI). Healthy subjects (HS; n = 51) were in similar age. Hypocholesterolaemia occurred in 31% of CF subjects and in no HS. Hypertriglyceridaemia concerned 21% of patients (HS: 8%, p = .04), and low HDL-C 45% (HS: 6%, p < .0001). At least one of these three CF dyslipidaemia disturbances was present in 62% of CF subjects, but there were no significant differences in oxLDL, oxLDL/LDL-C ratio, adiponectin, and APOE between CF and HS groups. PI was independently associated with low total cholesterol, LDL-C, and non-high density lipoprotein cholesterol, with age and sex also modifying lipid levels. In CF (n = 42), triglycerides did not correlate with serum tumour necrosis factor α (TNF-α). CONCLUSIONS: CF dyslipidaemia is highly prevalent and heterogenous. The lipid profile weakly associates with the clinical characteristics of CF as well as oxLDL, adiponectin, and APOE. Further research is needed, especially regarding HDL function in CF, the causes of hypertriglyceridaemia, and the value of essential fatty acid supplementation for CF dyslipidaemia.

Amaranth Oil Increases Total and LDL Cholesterol Levels without Influencing Early Markers of Atherosclerosis in an Overweight and Obese Population: A Randomized Double-Blind Cross-Over Study in Comparison with Rapeseed Oil Supplementation.

BACKGROUND: Atherosclerosis (AT) is a chronic inflammatory process in which oxidative stress is the key event. Amaranth oil (AmO) has potential hypolipidemic and antiatherogenic effects. The aim of the study was to compare the effects of AmO and rapeseed oil (RaO) supplementation on expression of early markers of AT and lipid profile in obese or overweight subjects. METHODS: A randomized, double-blinded cross-over study was conducted, in which participants took 20 mL of AmO in the first arm and 20 mL RaO in the second arm, switching after the washout period. Serum concentrations of adhesion molecules (sP-selectin, sVCAM-1), high-sensitivity C-reactive protein (hsCRP), asymmetric dimethylarginine (ADMA), and lipid profile were assessed before and after nutritional interventions. In addition, anthropometric parameters were measured. RESULTS: The total (TC) and low-density lipoprotein (LDL) cholesterol concentrations increased significantly in the AmO group in comparison with RaO (ΔTC 5.52 ± 35 vs. -8.43 ± 17.65 mg/dL; p = 0.002 and 4.43 ± 34.96 vs. -7.55 ± 16.41 mg/dL; p = 0.002, respectively). There were no significant differences in other parameters analyzed between the groups. CONCLUSION: The use of AmO instead of RaO may increase cardiovascular risk in obese and overweight subjects.

The Central European diet as an alternative to the Mediterranean diet in atherosclerosis prevention in postmenopausal obese women with a high risk of metabolic syndrome - a randomized nutrition-al trial.

BACKGROUND: Metabolic syndrome (MS) is a powerful risk factor for atherosclerosis (AT). The crucial meth- od of minimizing the development of atherosclerosis and its clinical manifestations is lifestyle modifications, including following a healthy diet. The aim of the study was to check if the Central European Diet (CED) could be an alternative to the Mediterranean Diet (MED) in the prevention of AT in patients with a risk of MS. METHODS: The randomized, single-blind nutritional trial involved 144 obese women with a risk of MS. The subjects were randomly assigned to two groups and followed MED (n = 72) or CED (n = 72) for 16 weeks. The concentrations of high-sensitivity C-reactive protein (hs-CRP) and asymmetrical dimethylarginine (ADMA) were measured before and after nutritional intervention. RESULTS: In both studied groups, the concentrations of hs-CRP decreased significantly after the nutritional in- tervention (CED: p = 0.0107; MED: p = 0.0002). The ADMA levels were significantly lower after nutritional intervention in the CED group (p = 0.0187) but not in the MED group (p = 0.8354). However, the observed changes of hs-CRP concentrations (Δhs-CRP) and ADMA levels (ΔADMA) were not different between the groups (p = 0.5307 and p = 0.0905, respectively). CONCLUSIONS: In the Central European post-menopausal obese population, a well-designed, energy-restricted diet with the use of food items traditional for the region (CED) could be a good alternative to MED in terms of AT prevention.

Fecal elastase-1 in healthy children up to 2 years of age: a cross-sectional study.

BACKGROUND: Fecal elastase-1 (E-1) levels in infants and young children may be expected to differ from those in adults and older children because of the immaturity of the gastrointestinal tract and the specificity of their diet. Despite the availability of data describing E-1 levels in the stools of preterm infants, older children, adults and subjects with malabsorption, there is still a lack of data regarding E-1 in healthy infants and toddlers. The aim of this cross-sectional study was to evaluate fecal E-1 concentrations in infants and children from 1 up to 24 months of age. MATERIAL AND METHODS: E-1 was measured in 160 healthy subjects aged 1-24 months (8 groups of 20: aged 1-3, 4-6 months, etc.) using an enzyme-linked immunosorbent assay (ELISA). RESULTS: Fecal E-1 concentrations ranged from 200 to 1695 µg/g of feces. No child had a fecal E-1 level below 200 µg/g of feces. Fecal E-1 concentrations did not significantly differ between age groups. However, fecal E-1 levels in the first 3 months were lower than in the second year of life (1-3 months vs 13-24 months, p=0.0230). A statistically significant correlation between the E-1 concentration and age was found (p=0.0007, r=0.2639; however, it does not affect the cut-off level of the reference values). The trend was rather exponential. Fecal E-1 values reached a plateau around the age of 6-10 months. CONCLUSIONS: Our study has shown that the fecal E-1 test can be reliably applied in infants and toddlers to confirm normal exocrine pancreatic function. However, within the first months of life fecal E-1 concentrations may be lower than later in life.

Conjugated linoleic acid does not affect digestion and absorption of fat and starch-a randomized, double-blinded, placebo-controlled parallel study.

OBJECTIVE: Conjugated linoleic acid (CLA) is known as a potent agent for altering body weight and composition. However, its effect on the process of digestion is still unknown. The aim of this study has been to elucidate the effect of a 3-month supplementation with CLA on starch and fat digestion and absorption in humans. APPROACH: The study included 74 obese and overweight adults who were randomized to receive 3.0 g of CLA or sunflower oil as placebo daily for 3 months. Digestion and absorption of fat and starch was assessed using non-invasive breath tests with a stable 13C isotope (cumulative percentage dose recovery, CPDR) before and after the supplementation period. To exclude the effect of oxidation, in addition total energy expenditure (TTE) was measured by a 13C bicarbonate breath test. RESULTS: The changes in CPDR values (∆CPDR median 〈interquartile range〉) were no different between subjects from the CLA group and the placebo group (fat: -0.2 〈-9.1-4.1〉 versus 0.6 〈-7.0-8.0〉, p < 0.4796; starch: -1.3 〈-9.5-2.4〉 versus -1.0 〈-5.1-1.7〉, p < 0.5520, respectively). The incidence of negative and positive values of ∆CPDR was no different between groups [for fat: 53.1% versus 46.7%, RR 1.138, (95% CI 0.689-1.882) and for starch: 67.7% versus 56.7%, RR 1.195, (95% CI 0.804-1.777)]. The changes in TTE did not differ between the CLA and the placebo group (respectively 1 〈48; 267〉 versus -8 〈-120;93〉 kcal; p < 0.2728). CONCLUSION: Supplementation with CLA for 3 months did not affect fat and starch digestion assessed by 13C mixed triglyceride breath test and 13C starch breath test.

Determinants of Serum Glycerophospholipid Fatty Acids in Cystic Fibrosis.

The etiology of altered blood fatty acid (FA) composition in cystic fibrosis (CF) is understood only partially. We aimed to investigate the determinants of serum glycerophospholipids' FAs in CF with regard to the highest number of FAs and in the largest cohort to date. The study comprised 172 CF patients and 30 healthy subjects (HS). We assessed Fas' profile (gas chromatography/mass spectrometry), CF transmembrane conductance regulator (CFTR) genotype, spirometry, fecal elastase-1, body height and weight Z-scores, liver disease, diabetes and colonization by Pseudomonas aeruginosa. The amounts of saturated FAs (C14:0, C16:0) and monounsaturated FAs (C16:1n-7, C18:1n-9, C20:1n-9, C20:3n-9) were significantly higher in CF patients than in HS. C18:3n-6, C20:3n-6 and C22:4n-6 levels were also higher in CF, but C18:2n-6, C20:2n-6 and C20:4n-6, as well as C22:6n-3, were lower. In a multiple regression analysis, levels of seven FAs were predicted by various sets of factors that included age, genotype, forced expiratory volume in one second, pancreatic status and diabetes. FA composition abnormalities are highly prevalent in CF patients. They seem to be caused by both metabolic disturbances and independent clinical risk factors. Further research into the influence of CFTR mutations on fat metabolism and desaturases' activity is warranted.

Exocrine pancreatic function in children with Alagille syndrome.

Alagille syndrome (AGS) is often associated with symptoms of maldigestion, such as steatorrhea, hypotrophy and growth retardation. Exocrine pancreatic insufficiency was proposed as the underlying cause. We aimed to assess the exocrine pancreatic function with the use of different methods in AGS patients. Concentrations of fecal elastase-1 (FE1) and fecal lipase (FL) activities were measured in 33 children with AGS. The C-mixed triglyceride breath test (MTBT) in a subgroup comprising 15 patients. In all patients studied, FE1 concentrations and FL activities were normal. Abnormal MTBT results were documented in 4 (26.7%) patients. The FE1 and FL levels in MTBT-positive and MTBT-negative children did not differ. The results of this research do not confirm the presence of exocrine pancreatic dysfunction in AGS patients. Routine screening for exocrine pancreatic insufficiency of this group of patients is not necessary.