Tolerability of Oral Supplementation with Microencapsulated Ferric Saccharate Compared to Ferrous Sulphate in Healthy Premenopausal Woman: A Crossover, Randomized, Double-Blind Clinical Trial.

A single-center, crossover, randomized, double-blind, and controlled clinical study was conducted to assess the tolerability profile, especially with regard to gastrointestinal complaints, of oral supplementation with AB-Fortis®, a microencapsulated ferric saccharate (MFS), as compared with conventional ferrous sulphate (FS) in healthy premenopausal women. A dose of 60 mg/day of elemental iron was used. The test products were administered for 14 consecutive days with a washout period of two menstrual episodes and a minimum of one month between the two intervention periods. The subjects completed simple-to-answer questionnaires daily for 14 days during both the intervention and the washout periods, capturing the symptoms associated with oral iron supplementation and overall health aspects. Following product consumption, the incidences of symptoms, numbers of complaints/symptoms, overall intensity, and total days with symptoms were found to be significantly higher for FS consumption as compared to MFS. The better tolerability profile of MFS over FS was further substantiated when both products were compared to a real-life setting (i.e., the washout period). Overall, the administration of both study products was safe with no serious or significant adverse events reported. In summary, the current study shows the better tolerability of the MFS preparation when compared to that of the FS, presenting MFS as a well-tolerated and safe option for improving iron nutrition.

Digestion-resistant maltodextrin effects on colonic transit time and stool weight: a randomized controlled clinical study.

PURPOSE: Increased awareness of the importance of dietary fibre has led to increased interest in "functional" fibre components like digestion-resistant maltodextrin (RMD). This randomized, placebo-controlled, double-blind study assessed the effects of RMD in the colonic transit time (CTT) and defecation characteristics (frequency, stool volume and consistency). METHODS: Sixty-six healthy adult volunteers (32 men) who did not have a daily defecation habit had a 7-day run-in period before the 21-day intervention period with RMD or placebo. CTT and segmental CTT (SCTT) were assessed by a single abdominal X-ray film taken at the end of both periods after radiopaque marker ingestion. Defecation characteristics and intestinal functions were also assessed, which were self-reported by patients. Intragroup comparisons were evaluated by Student's paired t test, Bonferroni test and Chi-square test, while time comparisons by analysis of variance (ANOVA) and time-by-treatment interaction by repeated-measures ANOVA. RESULTS: Fifty-seven subjects were assessed for CTT (placebo, n = 28; RMD, n = 29). In the RMD group, the total CTT, left SCTT and rectosigmoidal SCTT decreased significantly compared to baseline (p < 0.01 each; -13.3, -4.7, -8.7 h, respectively). Significant differences between groups were observed in total CTT and left SCTT. Significant time-by-treatment interaction was observed in the RMD group for stool volume (p = 0.014), increasing 56 % compared to baseline (p < 0.01), while remained unchanged in the placebo group. Stool consistency was improved only in the RMD group (p < 0.01). No adverse effects related to study products were observed. CONCLUSIONS: The results show that RMD improved CTT, stool volume, stool consistency and some intestinal functions in a healthy population.

Dietary supplementation with plant extracts for amelioration of persistent myofascial discomfort in the cervical and back regions: a randomized double-blind controlled study.

Background: Back pain is a common health problem that affects both workers and older people, reducing their quality of life. The primary objective was to assess the effect of dietary supplementation with plant extracts of rosemary, ashwagandha, and sesame consumed for 12 weeks on the intensity of back pain. Methods: A single-center randomized double-blind study with three parallel arms depending on the product consumed. The duration of treatment was 12 weeks. The investigational product, Berelief®, contained a blend of three polyphenolic standardized extracts: rosemary (Rosmarinus officinalis L.), ashwagandha (Withania somnifera L.), and sesame (Sesamum indicum L.) seed. Two doses were tested: low dose (400 mg) and high dose (800 mg). There were 42 subjects in the placebo group, 39 in the low dose and 42 in the high dose groups. Study variables included back pain intensity [VAS score, Patient-Reported Outcomes Measurement Information System (PROMIS-29), and Cornell Musculoskeletal Discomfort Questionnaire; functionality Roland-Morris Disability (RMD) questionnaire]; quality of life (QoL) [36-item Short Form Survey (SF-36), the Beck Depression Inventory-II (BDI-II), the State-Trait Anxiety Inventory (STAI), and the Perceived Stress Scale (PSS)]; sleep quality [accelerometer and Pittsburgh Sleep Quality Index (PSQI)]. Results: The improvement in back pain recorded by the visual analogue scale (VAS) at the study visits after the beginning of treatment, as well as on a weekly basis recorded in the diary card was significantly higher in the intervention group than in the placebo group (p < 0.044 dose-low; p < 0.005 dose-high). Significant differences in pain intensity of the PROMIS-29 (p = 0.002) and upper back pain in the Cornell questionnaire (p = 0.011) in favour of the investigational product were found. Furthermore, benefits in improving health-related quality of life, mood and sleep quality were also detected. Conclusion: Dietary supplementation for 12 weeks of a blend of polyphenolic standardized extracts of rosemary, ashwagandha, and sesame was effective in reducing the intensity of pain in subjects with chronic myofascial cervical and back pain.

Effect of a sustained-release formulation of ß-alanine on laboratory parameters and paresthesia in recreational trained men: a randomized double-blind placebo-controlled study.

Introduction: Beta-alanine is a non-essential amino acid that has been a focus of increasing research by its role as ergogenic aid to improve muscle performance. Methods: A randomized, double-blind and controlled trial was conducted to determine the effect of a nutritional supplement of a sustained-release formulation of ß-alanine in recreational trained men. The active product was an innovative sustained-release ß-alanine microgranules powder blend, administered at high doses (15 g/day) divided into 3 intakes during 30 days. There were 10 participants in the experimental group and 9 in the placebo group, with a mean age of 22.5 ± 3.3 years. Participants were testing at baseline and at the end of study. Results: In the ß-alanine group, there were statistically increases in serum triglycerides, LDL-cholesterol, and urea nitrogen at the end of the study as compared with baseline, although there were no differences with the control group. The occurrence of paresthesia, described above all as tickling, was the majority but presented VAS score less than 3/10 in almost all subjects. Discussion: More studies are required to evaluate the changes in blood parameters that can be caused by high intake of ß-alanine during a long period of time. Clinical trial registration: ClinicalTrials.gov, identifier (NCT05334121).

Correction: de Salazar et al. Oxidative Stress in Endurance Cycling Is Reduced Dose-Dependently after One Month of Re-Esterified DHA Supplementation. Antioxidants 2020, 9, 1145.

Carlos Contreras was not included as an author in the published article [...].

Effect of Dietary Supplementation with a Natural Extract of Sclerocarya birrea on Glycemic Metabolism in Subjects with Prediabetes: A Randomized Double-Blind Placebo-Controlled Study.

A randomized, double-blind, placebo-controlled study was conducted with the primary objective of assessing the effect of a natural extract of Sclerocarya birrea on glucose metabolism in subjects with prediabetes. The duration of the study was 90 days. Thirty-three subjects assigned to the experimental group (daily ingestion of 100 mg of the nutraceutical product) and 34 assigned to the placebo group completed the study. There were 36 men and 31 women with a mean age of 32.3 ± 14.1 years. In the area under the curve (AUC) of the oral glucose tolerance test (OGTT), statistically significant decreases in the experimental group at 40 and 90 days as compared with baseline were found, whereas significant changes in the placebo group were not observed. Within-group differences were statistically significant in favor of the experimental group for glucose peak at OGTT, serum insulin, insulin resistance markers, and flow-mediated dilation. Changes in lipid and anthropometric parameters were not observed, although there was a trend for lower cholesterol levels and a decrease in body weight in the experimental group. Decreases in systolic blood pressure were also higher among subjects in the experimental group. This exploratory study confirms the antidiabetic activity of Sclerocarya birrea in prediabetes. Further studies using better measurements of beta-cell function are needed to clarify the underlying mechanisms of the hypoglycemic effect of this natural compound.

Antioxidant Effect of a Probiotic Product on a Model of Oxidative Stress Induced by High-Intensity and Duration Physical Exercise.

This randomized double-blind and controlled single-center clinical trial was designed to evaluate the effect of a 6-week intake of a probiotic product (1 capsule/day) vs. a placebo on an oxidative stress model of physical exercise (high intensity and duration) in male cyclists (probiotic group, n = 22; placebo, n = 21). This probiotic included three lyophilized strains (Bifidobacterium longum CECT 7347, Lactobacillus casei CECT 9104, and Lactobacillus rhamnosus CECT 8361). Study variables were urinary isoprostane, serum malondialdehyde (MDA), serum oxidized low-density lipoprotein (Ox-LDL), urinary 8-hydroxy-2'-deoxiguanosine (8-OHdG), serum protein carbonyl, serum glutathione peroxidase (GPx), and serum superoxide dismutase (SOD). At 6 weeks, as compared with baseline, significant differences in 8-OHdG (Δ mean difference -10.9 (95% CI -14.5 to -7.3); p < 0.001), MDA (Δ mean difference -207.6 (95% CI -349.1 to -66.1; p < 0.05), and Ox-LDL (Δ mean difference -122.5 (95% CI -240 to -4.5); p < 0.05) were found in the probiotic group only. Serum GPx did not increase in the probiotic group, whereas the mean difference was significant in the placebo group (477.8 (95% CI 112.5 to 843.2); p < 0.05). These findings suggest an antioxidant effect of this probiotic on underlying interacting oxidative stress mechanisms and their modulation in healthy subjects. The study was registered in ClinicalTrials.gov (NCT03798821).

Effectiveness of Consumption of a Combination of Citrus Fruit Flavonoids and Olive Leaf Polyphenols to Reduce Oxidation of Low-Density Lipoprotein in Treatment-Naïve Cardiovascular Risk Subjects: A Randomized Double-Blind Controlled Study.

The aim of the study was to assess whether oral intake of a nutraceutical product (Citrolive™) could determine changes in low-density lipoprotein (LDL) oxidation and other parameters of lipid metabolism and plasma atherogenic capacity. Citrolive™ is a commercial extract obtained from the combination of citrus fruit flavonoids and olive leaf extracts. Twenty-three untreated subjects (69.6% males, 30.4% females, mean age 41.9 ± 9.4 years) with cardiovascular risk factors and a total cholesterol level >200 mg/dL and LDL cholesterol (LDL-C) > 130 mg/dL participated in a 3-month randomized double-blind controlled study. Participants in the intervention group (71.4% males, 28.6% females, mean age 42.7 ± 9.7 years) consumed Citrolive™ (500 mg, two capsules/day), and controls (66.7% males, 33.3% females, mean age 40.6 ± 9.4 years) received a matched placebo. At 3 months, oxidized LDL (ox-LDL) decreased significantly in the intervention group from 93.8 ± 19.1 U/L to 62.8 ± 28.7 U/L (p < 0.05), whereas the control group increased from 98.2 ± 23.5 U/L to 105.7 ± 21.9 U/L (p = 0.1). Between-group differences were also significant (p < 0.05). Similar findings in the ox-LDL/LDL-C ratio were observed. Serum paraoxonase activity (PON1) increased significantly in the intervention group from 64.5 ± 15.6 U/L to 78.7 ± 28.8 U/L (p < 0.05) but remained unchanged in controls. Consumption of Citrolive™ for 3 months in treatment-naïve subjects with moderate risk of atherosclerosis was associated with a reduction in oxidized LDL-C and LDL-oxidase/LDL-C ratio as compared to controls.

Dissociable Effects of Executive Load on Perceived Exertion and Emotional Valence during Submaximal Cycling.

Endurance physical exercise is accompanied by subjective perceptions of exertion (reported perceived exertion, RPE), emotional valence, and arousal. These constructs have been hypothesized to serve as the basis for the exerciser to make decisions regarding when to stop, how to regulate pace, and whether or not to exercise again. In dual physical-cognitive tasks, the mental (executive) workload generated by the cognitive task has been shown to influence these perceptions, in ways that could also influence exercise-related decisions. In the present work, we intend to replicate and extend previous findings that manipulating the amount of executive load imposed by a mental task, performed concomitantly with a submaximal cycling session, influenced emotional states but not perceived exertion. Participants (experienced triathletes) were asked to perform a submaximal cycling task in two conditions with different executive demands (a two-back version of the n-back task vs. oddball) but equated in external physical load. Results showed that the higher executive load condition elicited more arousal and less positive valence than the lower load condition. However, both conditions did not differ in RPE. This experimental dissociation suggests that perceived exertion and its emotional correlates are not interchangeable, which opens the possibility that they could play different roles in exercise-related decision-making.

Re-esterified DHA improves ventilatory threshold 2 in competitive amateur cyclists.

BACKGROUND: Fish oils were studied as ergogenic aids in a number of mixed physical trial designs showing promising results. However, the heterogeneous purity of the studied supplements, combined with the variety of physical tests employed call for more studies to confirm these findings, ideally with standardised supplements. Our aim was to test a supplement highly concentrated in DHA (DHA:EPA ratio equal to approximately 8:1) on a maximal cycling test to elucidate performance improvements mainly due to DHA. METHODS: A double-blind, placebo controlled, randomised balanced, parallel design, in competitive amateur cyclists was employed. They were all male, older than 18 years old, with training routine of 2 to 4 sessions per week lasting at least one hour each. A ramp cycling test to exhaustion with a subsequent 5 min recovery phase was employed before and after treatment to analyse aerobic metabolism and lactate clearance after the bout. After 30 days of supplementation with 975 mg of re-esterified DHA, the thirty-eight cyclist who completed the study were finally included for statistical analysis. RESULTS: Mean power output at ventilatory threshold 2 (VT2) improved after DHA supplementation both as absolute (△DHA versus △PLA: 6.33-26.54 Watts; CI 95%) and relative (p=0.006) values, paralleled with higher oxygen consumption at VT2 both for absolute (DHA 2729.4 ±304.5, 3045.9 ±335.0; PLA 2792.3 ±339.5, 2845.5 ±357.1; ml·min-1 baseline versus post p=0.025) and relative values (DHA 36.6 ±5.0, 41.2 ±5.4; PLA 37.2 ±5.7, 38.1 ±5.2; ml·kg-1·min-1 baseline versus post p=0.024). Heart rate recovery rate improved during the recovery phase in the DHA group compared to PLA (p=0.005). CONCLUSION: DHA is capable of improving mean power output at the ventilatory threshold 2 (anaerobic ventilatory threshold) in amateur competitive cyclists. It is unclear if these findings are the result of the specific DHA supplement blend or another factor.

Oxidative Stress in Endurance Cycling Is Reduced Dose-Dependently after One Month of Re-Esterified DHA Supplementation.

Docosahexaenoic acid (DHA) supplementation can reduce exercise-induced oxidative stress generated during long aerobic exercise, with the minimum dose yet to be elucidated for physically active subjects. In this study, we performed a dose finding with re-esterified DHA in triglyceride form in a randomized double-blind parallel trial at different doses (350, 1050, 1750, and 2450 mg a day) for 4 weeks in males engaged in regular cycling (n = 100, 7.6 ± 3.7 h/week). The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention. To ascertain incorporation of DHA, erythrocyte polyunsaturated fatty acid (PUFA) composition was compared along groups. We found a dose-dependent antioxidant capacity of DHA from 1050 mg with a trend to neutralization for the highest dose of 2450 mg (placebo: n = 13, F = 0.041; 350 mg: n = 10, F = 0.268; 1050 mg: n = 11, F = 7.112; 1750 mg: n = 12, F = 9.681; 2450 mg: n = 10, F = 15.230). In the erythrocyte membrane, the re-esterified DHA increased DHA and omega-3 percentage and decreased omega 6 and the omega-6 to omega-3 ratio, while Eicosapentaenoic acid (EPA) and PUFA remained unchanged. Supplementation of re-esterified DHA exerts a dose-dependent endogenous antioxidant property against moderate-intensity long-duration aerobic exercise in physically active subjects when provided at least 1050 mg a day for 4 weeks.

Supplementation of Re-Esterified Docosahexaenoic and Eicosapentaenoic Acids Reduce Inflammatory and Muscle Damage Markers after Exercise in Endurance Athletes: A Randomized, Controlled Crossover Trial.

This study aimed to analyse the effect of 10 weeks of a highly concentrated docosahexaenoic acid (DHA) + eicosapentaenoic (EPA) supplementation (ratio 8:1) on strength deficit and inflammatory and muscle damage markers in athletes. Fifteen endurance athletes participated in the study. In a randomized, double-blinded cross-over controlled design, the athletes were supplemented with a re-esterified triglyceride containing 2.1 g/day of DHA + 240 mg/day of EPA or placebo for 10 weeks. After a 4-week wash out period, participants were supplemented with the opposite treatment. Before and after each supplementation period, participants performed one eccentric-induced muscle damage exercise training session (ECC). Before, post-exercise min and 24 and 48 h after exercise, muscle soreness, knee isokinetic strength and muscle damage and inflammatory markers were tested. No significant differences in strength deficit variables were found between the two conditions in any of the testing sessions. However, a significant effect was observed in IL1ß (p = 0.011) and IL6 (p = 0.009), which showed significantly lower values after DHA consumption than after placebo ingestion. Moreover, a significant main effect was observed in CPK (p = 0.014) and LDH-5 (p = 0.05), in which significantly lower values were found after DHA + EPA consumption. In addition, there was a significant effect on muscle soreness (p = 0.049), lower values being obtained after DHA + EPA consumption. Ten weeks of re-esterified DHA + EPA promoted lower concentrations of inflammation and muscle damage markers and decreased muscle soreness but did not improve the strength deficit after an ECC in endurance athletes.

Pomegranate Extract Improves Maximal Performance of Trained Cyclists after an Exhausting Endurance Trial: A Randomised Controlled Trial.

The efficacy of pomegranate (Punica granatum) extract (PE) for improving performance and post-exercise recovery in an active population was equivocal in previous studies. In this study, a randomised, double-blinded, placebo-controlled, balanced, cross-over trial with two arms was conducted. Eligibility criteria for participants were as follows: male, amateur cyclist, with a training routine of 2 to 4 sessions per week (at least one hour per session). The cyclists (n = 26) were divided into treatment (PE) and placebo (PLA) groups for a period of 15 days. After physical tests, the groups were exchanged after a 14-day washout period. Exercise tests consisted of endurance bouts (square-wave endurance exercise test followed by an incremental exercise test to exhaustion) and an eccentric exercise drill. The objective was to assess the efficacy of PE in performance outcomes and post-exercise muscular recovery and force restoration after a prolonged submaximal effort. Twenty-six participants were included for statistical analysis. There was a statistically significant difference in total time to exhaustion (TTE)(17.66⁻170.94 s, p < 0.02) and the time to reach ventilatory threshold 2 (VT2)(26.98⁻82.55 s, p < 0.001), with greater values for the PE compared to the PLA group. No significant results were obtained for force restoration in the isokinetic unilateral low limb test. PE, after a prolonged submaximal effort, may be effective in improving performance outcomes at maximal effort and might help to restore force in the damaged muscles.