Assessing electronic device use behaviours in healthy adults: development and evaluation of a novel tool.

BACKGROUND: Chronic exposure of the macula to blue light from electronic devices has been identified as a potential macular health concern. The impacts remain poorly investigated as no validated methods to capture usual device use behaviours exist. PURPOSE: The aim of this study was to develop and validate the Electronic Device Use Questionnaire (EDUQ) against multiple 24-h electronic device use diaries in healthy Australian and United Kingdom adults. METHODS: The EDUQ and diaries were developed to capture device use across categories (television, computer and handheld devices). Over eight weeks 56 Australian and 24 United Kingdom participants completed three questionnaires and eight diaries via online platforms. Tool validity was determined through Bland-Altman plot analysis of mean daily hours of device use between the tools. RESULTS: The EDUQ demonstrated poor validity in both cohorts with poor agreement when compared with the diaries. When the device categories were combined, a mean difference between the tools of 1.54 h/day, and 95% limits of agreement between -2.72 h/day and 5.80 h/day was observed in the Australian cohort. Across both cohorts and all device categories the mean differences indicated individuals were more likely to report higher device use through the questionnaire rather than diaries. CONCLUSIONS: The EDUQ is a novel tool and demonstrated the difficulty for participants of accurately recalling usual behaviour of device use. Poor agreement in reported device use occurred across all device categories. The poor agreement may be related to factors such as memory recall bias, and the number of diaries captured not being reflective of usual use. Future studies should look to address these factors to improve validity of device use capture.

Efficacy of Topical Palmitoylethanolamide (Levagen+) for the Management of Eczema Symptoms: A Double-Blind, Comparator-Controlled, Randomized Clinical Trial.

INTRODUCTION: Eczema is a debilitating skin disorder clinically characterised by the development of itchy, dry, rough, and scaling skin caused by a series of rudimentary clinical phenotypes. METHODS: This double-blind, randomised, comparator-controlled trial evaluated the effectiveness of topical application of a novel palmitoylethanolamide formulation (Levagen+) compared with a standard moisturiser (comparator) to reduce eczema severity and improve patient outcomes. Seventy-two participants aged over 18 years old with atopic eczema (symptoms including redness, dry skin, scaling, and/or itchiness) on their hands or arm were recruited. Participants were randomly allocated to one of two treatment groups (Levagen + or comparator). Treatment was applied to the affected area twice daily for 4 weeks. Outcome measures included Self-Assessed Eczema Area Severity Index (SA-EASI) scoring and Patient-Oriented Eczema Measure (POEM) from baseline to week 4. RESULTS: Levagen+ was effective at alleviating symptom severity of eczema over 4 weeks. Levagen+ significantly reduced redness, dryness, and total POEM score compared to a comparator cream. CONCLUSION: Levagen+ can significantly reduce eczema symptom severity compared to a comparator product, supporting its use as a potential treatment for eczema. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05003453.

The effect of an orally-dosed Gynostemma pentaphyllum extract (ActivAMP®) on body composition in overweight, adult men and women: A double-blind, randomised, placebo-controlled study.

BACKGROUND: The present study examined the effect of a herbal supplement containing a Gynostemma pentaphyllum (Gpp) extract (ActivAMP®) with respect to improving body composition in overweight males and females. METHODS: One-hundred and seventeen men and women aged over 18 years completed 16 weeks of daily supplementation with either Gpp or a placebo. Participants underwent dual-energy X-rays to assess body composition (fat mass, lean mass and mass distribution), as well as anthropometric measures (weight, height, hip and waist circumference), in addition to blood tests to assess inflammatory and safety markers. RESULTS: Following 16 weeks of treatment, the Gpp group had a significant reduction in total body weight, body mass index, total fat mass and gynoid fat mass compared to the placebo group. Blood measures showed plasma triglyceride, alanine aminotransferase and tumour necrosis factor-α to be statistically different between groups at week 16. Subgroup analysis of gender for fat distribution showed males in the Gpp group had a significant reduction in visceral fat compared to males in the placebo group and females in the Gpp group had a significant reduction in gynoid fat compared to the placebo group. CONCLUSIONS: Gpp was capable of altering fat mass and fat distribution in overweight and obese males and females compared to a placebo.

Reliability of a point-of-care device to determine oxidative stress in whole blood before and after acute exercise: A practical approach for the applied sports sciences.

Measuring alterations in redox homoeostasis in athletes can provide insights into their responses to training such as adaptations or fatigued states. However, redox monitoring is impractical in athletes given the time burden of venepuncture and subsequent laboratory assays. The ability of point-of-care tests (POC): 1) Free Oxygen Radical Test (FORT) and 2) Free Oxygen Radical Defence (FORD), to reliably measure whole blood oxidative stress between days and after exercise is unknown as well as their relationship with laboratory measures (F2-isoprostanes, total antioxidant capacity; TAC). Participants completed two trials performed on separate days comprising blood sampling at rest (n=22) and after treadmill-running (n=14). Between-day CVs for FORT (4.6%) and FORD (4.8%) were acceptable at rest. There was no difference in the between-day magnitude of change in any biomarker from pre- to post-exercise (p>0.05), yet the within-trial change in FORD was variable (trial one: +4.5%, p=0.15; trial two: +6.3%, p<0.05). TAC and FORD were significantly correlated pre- and post-exercise (r=~0.53, p<0.05), whereas F2-isoprostanes and FORT had a significant correlation pre-exercise only (r=0.45, p=0.03). Overall, the POC tests are reliable and could be used for baseline longitudinal redox monitoring. More data is required on POC tests for assessing redox perturbations induced by exercise.

A self-emulsifying Omega-3 ethyl ester formulation (AquaCelle) significantly improves eicosapentaenoic and docosahexaenoic acid bioavailability in healthy adults.

PURPOSE: Application of intelligent formulation design has the ability to address the poor bioavailability and improve the fasted state bioavailability of fish oils. In this study we assessed the ability of a self-emulsifying drug delivery system (SEDDS), AquaCelle®, as an additive to enhance the oral absorption of Omega-3 ethyl esters (EE) in healthy subjects under low-fat diet conditions. METHODS: Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) EE were formulated with AquaCelle®. A single dose (680 mg dose of oil containing 272 mg of EPA EE and 204 mg of DHA EE), randomized, double-blind, study measured uptake of EPA and DHA over 24 h in healthy adults. Participants were randomized into two groups, receiving either the SEDDS AquaCelle® fish oil formulation or the unformulated fish oil EE as control. RESULTS: The AquaCelle® fish oil EE formulation demonstrated instant and complete emulsification on addition to water to produce an emulsion with an average diameter of 43 µm, compared to the oil alone which did not emulsify. The study revealed a significant difference in absorption (Cmax and AUC0-24h) between the AquaCelle® group and the control group. The AquaCelle® group was capable of increasing maximum plasma concentrations and absorption (AUC0-24h) of total Omega-3 (EPA + DHA) 3.7- and 7.1-fold, respectively, compared to the control. CONCLUSION: Formulating Omega-3 EE with a SEDSS concentrate (AquaCelle®) demonstrated a significant improvement in the oral absorption of Omega-3 fatty acids without requiring a high-fat meal.

The role of the gastrointestinal tract and microbiota on uremic toxins and chronic kidney disease development.

It is well-established that uremic toxins are positively correlated with the risk of developing chronic kidney disease and cardiovascular disease. In addition, emerging data suggest that gut bacteria exert an influence over both the production of uremic toxins and the development of chronic kidney disease. As such, modifying the gut microbiota may have the potential as a treatment for chronic kidney disease. This is supported by data that suggest that rescuing microbiota dysbiosis may: reduce uremic toxin production; prevent toxins and pathogens from crossing the intestinal barrier; and, reduce gastrointestinal tract transit time allowing nutrients to reach the microbiota in the distal portion of the gastrointestinal tract. Despite emerging literature, the gut-kidney axis has yet to be fully explored. A special focus should be placed on examining clinically translatable strategies that might encourage improvements to the microbiome, thereby potentially reducing the risk of the development of chronic kidney disease. This review aims to present an overview of literature linking changes to the gastrointestinal tract with microbiota dysbiosis and the development and progression of chronic kidney disease.

Microbiota and the nitrogen cycle: Implications in the development and progression of CVD and CKD.

Chronic kidney disease (CKD) is associated with an increased risk of death from cardiovascular disease (CVD). One factor involved in CVD development is nitric oxide (NO), which acts as a powerful vasodilator. NO is produced via the nitrogen cycle, through the reduction of nitrate to nitrite with the process mainly occurring in the mouth by commensal microbiota. People with CKD have compromised microbiota (dysbiosis) with an increased abundance of potentially pathogenic and pro-inflammatory bacteria capable of producing uremic toxins that contribute to CKD development and reduce enzymatic NO production. However, to date, few studies have comprehensively documented the gut or saliva microbiota in the CKD population or investigated the role of NO in people with CKD. This review will discuss NO pathways that are linked to the progression of CKD and CVD and therapeutic options for targeting these pathways.

Glutathione depletion and acute exercise increase O-GlcNAc protein modification in rat skeletal muscle.

Post-translational modification of intracellular proteins with O-linked ß-N-acetylglucosamine (O-GlcNAc) profoundly affects protein structure, function, and metabolism. Although many skeletal muscle proteins are O-GlcNAcylated, the modification has not been extensively studied in this tissue, especially in the context of exercise. This study investigated the effects of glutathione depletion and acute exercise on O-GlcNAc protein modification in rat skeletal muscle. Diethyl maleate (DEM) was used to deplete intracellular glutathione and rats were subjected to a treadmill run. White gastrocnemius and soleus muscles were analyzed for glutathione status, O-GlcNAc and O-GlcNAc transferase (OGT) protein levels, and mRNA expression of OGT, O-GlcNAcase and glutamine:fructose-6-phosphate amidotransferase. DEM and exercise both reduced intracellular glutathione and increased O-GlcNAc. DEM upregulated OGT protein expression. The effects of the interventions were significant 4 h after exercise (P < 0.05). The changes in the mRNA levels of O-GlcNAc enzymes were different in the two muscles, potentially resulting from different rates of oxidative stress and metabolic demands between the muscle types. These findings indicate that oxidative environment promotes O-GlcNAcylation in skeletal muscle and suggest an interrelationship between cellular redox state and O-GlcNAc protein modification. This could represent one mechanism underlying cellular adaptation to oxidative stress and health benefits of exercise.

Variability of oxidative stress biomarkers in hemodialysis patients.

Oxidative stress biomarkers may have a role in the future to assist clinical decisions regarding the use of antioxidant therapies and their efficacy. The aims of this study were to evaluate the within and between-individual variability of plasma oxidative stress biomarkers and investigate factors affecting their variability. Plasma F2-isoprostanes and protein carbonyls were measured in 14 hemodialysis patients every 2 weeks for 10 weeks. Within-individual coefficients of variation (CVs) were isoprostanes = 30.4% (range = 6.1-66.7%) and protein carbonyls = 16.3% (8.4-29.5%). Between-individual CVs were isoprostanes = 34.4% (28.9-40.2%) and protein carbonyls = 19.5% (15.6-24.5%). There were no significant (p > 0.05) relationships between the oxidative stress biomarkers and dietary antioxidant intake, medications, clinical and demographic parameters.

Effects of probiotics supplementation on gastrointestinal permeability, inflammation and exercise performance in the heat.

PURPOSE: This study aimed to investigate the effects of multi-strain probiotics supplementation on gastrointestinal permeability, systemic markers of inflammation and running performance when exercising in the heat. METHODS: Ten male runners were randomized to 4 weeks of daily supplementation with a probiotics capsule (45 billion CFU of Lactobacillus, Bifidobacterium and Streptococcus strains) or placebo, separated by a washout period (double-blind, cross-over trial). After each treatment, the runners exercised to fatigue at 80% of their ventilatory threshold at 35 °C and 40% humidity. To assess gastrointestinal permeability, runners ingested lactulose and rhamnose before exercise and post-exercise urine was collected to measure sugar concentrations. Venous blood samples were collected before, immediately after and 1 h after exercise, and core temperature was monitored during exercise. RESULTS: Probiotics supplementation significantly increased run time to fatigue (min:s 37:44 ± 2:42 versus 33:00 ± 2:27; P = 0.03, d = 0.54). Average core temperature during exercise was similar between trials (probiotic 38.1 ± 0.2 °C, placebo 38.1 ± 0.1 °C; P = 0.77, d = 0.13). Serum lipopolysaccharide concentration increased post-exercise (P < 0.001), while there was a moderate to large reduction in pre-exercise (d = 0.70) and post-exercise (d = 1.24) concentration following probiotics supplementation. Plasma concentrations of IL-6, IL-10 and IL-1ra increased after exercise (P < 0.01), but there was no significant difference between trials (P > 0.05). There was a small to moderate reduction (d = 0.35) in urine lactulose:rhamnose and a small reduction (d = 0.25) in symptoms of gastrointestinal discomfort following probiotics supplementation (both P = 0.25). CONCLUSION: Four weeks of supplementation with a multi-strain probiotic increased running time to fatigue in the heat. Further studies are required to elucidate the exact mechanisms for this performance benefit.

Probiotics, prebiotics and the gastrointestinal tract in health and disease.

The microbiome located in the human gastrointestinal tract (GIT) comprises the largest community (diverse and dense) of bacteria, and in conjunction with a conducive internal milieu, promotes the development of regulated pro- and anti-inflammatory signals within the GIT that promotes immunological and metabolic tolerance. In addition, host-microbial interactions govern GIT inflammation and provide cues for upholding metabolic regulation in both the host and microbes. Failure to regulate inflammatory responses can increase the risk of developing inflammatory conditions in the GIT. Here, we review clinical studies regarding the efficacy of probiotics/prebiotics and the role they may have in restoring host metabolic homeostasis by rescuing the inflammatory response. The clinical studies reviewed included functional constipation, antibiotic-associated diarrhoea, Clostridium difficile diarrhoea, infectious diarrhoea/gastroenteritis, irritable bowel syndrome, inflammatory bowel diseases and necrotizing enterocolitis. We have demonstrated that there was an overall reduction in risk when probiotics were administered over placebo in the majority of GIT inflammatory conditions. The effect size of a cumulative reduction in relative risk for the GIT conditions/diseases investigated was 0.65 (0.61-0.70) (z = 13.3); p < 0.0001 that is an average reduction in risk of 35 % in favour of probiotics. We also progress a hypothesis that the GIT comprises numerous micro-axes (e.g. mucus secretion, Th1/Th2 balance) that are in operational homeostasis; hence probiotics and prebiotics may have a significant pharmacobiotic regulatory role in maintaining host GIT homeostasis in disease states partially through reactive oxygen species signalling.

Effectiveness of Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Pain, Duration, and Medication Use during Migraines in Otherwise Healthy Participants-A Double-Blind Randomised Controlled Study.

Migraines are a common neurological disorder that generally affects young to middle-aged adults and females more than males. Various treatment options are available; however, these can cause undesirable side effects. Therefore, alternative treatments with minimal side effects are still being investigated. Palmitoylethanolamide (PEA) is a signalling lipid known to have anti-inflammatory and analgesic properties. Previous prophylactic research has reported PEA supplementation to decrease pain associated with migraines. Upon commencement of migraine symptoms, participants were supplemented with either 600 mg of PEA (Levagen+) or a placebo (maltodextrin). Once a dose was taken, participants recorded a visual analogue scale (VAS) for pain every 30 min for 4 h or until the migraine resolved. If the migraine had not resolved 2 h post-dose, participants were instructed to take a second dose. Levagen+ supplementation resolved more headaches after 2- and 8 h, had a lower VAS for pain score at 1.5 and 4 h, and reduced rescue medication use significantly more than a placebo. No adverse events were reported in either group. Overall, PEA was safe and effective in reducing migraine pain, duration, and medication use in an otherwise healthy adult population.

A randomized double-blind trial to measure the absorption characteristics of eicosapentaenoic acid and docosahexaenoic acid rich oil blend with natural lipid-based delivery system.

A randomized, double-blinded trial with 65 subjects was conducted to compare the pharmacokinetics between PhytoMarineCelle (PM) that consists of eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) plus a self-emulsifying drug delivery system (SEDDS), and a standard EPA + DHA ethyl ester (SEE) that does not contain SEDDS. PM showed 1.6-fold greater plasma area under the curve (AUC) than SEE at 300 mg, although no significant difference was observed. PM showed a 3.1 and 3.2-fold (p < 0.05) greater plasma AUC than SEE at 500 mg and 1000 mg respectively. The concentration max (Cmax) of EPA + DHA did not change between PM and SEE at 300 mg. Cmax of PM was twofold greater than SEE at 500 mg and 1000 mg respectively. The Cmax of EPA + DHA achieved significant difference (p < 0.05) only with the 500 mg dose. The PM formulation increased the bioavailability of EPA + DHA by threefold compared to SEE at 500 and 1000 mg.

Effect of Palmitoylethanolamide Compared to a Placebo on the Gut Microbiome and Biochemistry in an Overweight Adult Population: A Randomised, Placebo Controlled, Double-Blind Study.

This study investigates the effects of palmitoylethanolamide (PEA) on the gut microbiome of overweight adults. Fifty-eight participants (twenty males, thirty-eight females) aged 18-65 years with a BMI range of 30-40 kg/m2 were recruited. Participants were randomised to receive PEA (n = 36) or a placebo (n = 22) for 12 weeks. Microbiota composition, richness, diversity, and metabolic functions, faecal short chain fatty acids and calprotectin, pathology markers, and health-related questionnaires were analysed throughout the 12 weeks of supplementation. PEA supplementation significantly reduced triglyceride levels and IL-2 concentrations. No significant differences were found in the overall microbiota composition between the groups, and microbiota richness and diversity remained consistent for both groups. Functional analysis demonstrated no differences in functional richness and diversity, but specific pathways were modified. PEA supplementation resulted in a decrease in the abundance of pathways related to aromatic compound degradation, NAD interconversion, and L-glutamate degradation, while pathways associated with molybdopterin biosynthesis and O-antigen building blocks exhibited increased abundance. Increased production of O-antigen results in smooth LPS associated with reduced pathogenic stealth and persistence. PEA supplementation may influence specific microbial species, metabolic pathways, and reduce serum triglyceride and IL-2 concentration, shedding light on the intricate relationship between PEA, the microbiome, and host health.

Newly developed dietary assessment tools for lutein and zeaxanthin are correlated with 24-hour diet recalls, but are not a valid measure of intake in Australian and United Kingdom adults.

Habitual dietary intake measurement of carotenoids lutein and zeaxanthin (L/Z) has often been omitted or attempted with tools of unknown validity in past research. It was hypothesized that the dietary assessment tool, the L/Z screener, developed as part of this study, would be valid with agreement within 0.25 mg/day when compared against multiple 24-hour diet recalls in healthy Australian and United Kingdom adults. Two screeners with 91 food items were developed, 1 with a recall timeframe of a month and the other a week. Over 4 weeks, 56 Australian and 47 United Kingdom participants completed 4 weekly screeners, 2 monthly screeners, and eight 24-hour diet recalls. Validity was assessed through Bland-Altman plot analysis. L/Z intake measured by all tools was significantly correlated, with correlation coefficients from 0.58 to 0.83. Despite these correlations, the screeners were not valid, with poor Bland-Altman plot agreement when compared with the diet recalls. The Australian weekly screener performed best, demonstrating a mean difference of 0.51 mg/day and 95% limits of agreement between -1.46 mg/day and 2.49 mg/day of L/Z intake. Baby spinach, broccoli, and pumpkin provided the greatest proportion of L/Z intake. The low validity may be explained by high rates of misestimation or missed capture of moderate to high L/Z containing foods such as baby spinach. Prior research reliant on correlational statistics for L/Z tool validity should be interpreted with caution, and future screener development should prioritize accurate capture of high contribution foods.

Variability in oxidative stress biomarkers following a maximal exercise test.

The oxidative stress response to maximal exercise may provide useful clinical biomarkers for assessing redox homeostasis. The aim was to determine the between-individual variability in the exercise-induced change in oxidative stress measures and investigate predictors of these responses. Plasma F2-isoprostanes (Isop), protein carbonyls (PCs), glutathione peroxidase (GPX) activity and total antioxidant capacity (TAC) were measured before and after a maximal treadmill exercise test. Exercise produced significant increases in Isop (27.0%), PC (6.2%) and GPX (7.8%). There were large between-individual coefficients of variation: Isop (152%), PC, (240%), GPX (130%) and TAC (243%).

The Effect of Levagen+ (Palmitoylethanolamide) Supplementation on Symptoms of Allergic Rhinitis-A Double-Blind Placebo-Controlled Trial.

BACKGROUND: Allergic rhinitis (AR) is an inflammatory, symptomatic disorder stimulated by antigen-specific immunoglobulin E inflammation in response to allergens. Current treatments include the use of corticosteroids and antihistamines to reduce inflammation by preventing histamine release. Palmitoylethanolamide (PEA) is reported to be an alternative treatment, shown to downregulate mast cell activation and increase the synthesis of endocannabinoid 2-Arachidonoylglycerol to reduce histamine and the symptoms of AR. METHOD: A double-blind, randomised, placebo-controlled clinical trial in which 108 participants presenting with seasonal AR were supplemented with either 350 mg of PEA (Levagen+) or a placebo daily for two weeks. Symptom scores were recorded using the reflective total nasal symptom score (rTNSS) twice a day (morning and evening) for the two weeks, and blood was taken at baseline and week 2. RESULTS: 101 participants completed the study with no baseline group differences. No significant difference was seen between groups for allergy symptoms scores (rTNSS) throughout the 14 days of treatment. A sub-group analysis of participants scoring over four (mild-to-moderate) on the total rTNSS at baseline showed that Levagen+ significantly reduced scores compared to the placebo group. Only 36 participants had full sets of blood taken due to COVID-19. The pathology results showed a significant difference in change from baseline between groups. The Levagen+ group had a significant decrease from baseline in histamine, IL-4, IL-8, IL-10, and TNF-α. The placebo group only had a reduction in IL-4. CONCLUSION: The results of this study show that Levagen+ can alleviate AR symptoms, resulting in a reduction in histamine and inflammatory markers.

The Efficacy of Palmitoylethanolamide (Levagen+) on the Incidence and Symptoms of Upper Respiratory Tract Infection-A Double Blind, Randomised, Placebo-Controlled Trial.

INTRODUCTION: Upper respiratory tract infections (URTIs) are caused by bacteria or viruses, with the most common causes being the common cold and influenza. The high occurrence of URTI means therapies that are effective with minimal side effects are in constant demand. Palmitoylethanolamide (PEA) is a signaling lipid previously shown to be effective in improving the incidence of URTIs. The aim of this study was to assess the effectiveness of PEA (Levagen+) on URTI incidence, duration, and severity. METHODS: Participants (n = 426) consumed either 300 mg of Levagen+ or a placebo (maltodextrin) twice daily for 12 weeks. Participants completed the Wisconsin Upper Respiratory Symptom Survey 24 questionnaire daily upon the commencement of symptoms until symptoms subsided. RESULTS: The Levagen+ group reported fewer URTI episodes (39 vs. 64) compared to the placebo group. The Levagen+ group reported a significant reduction in the median severity score of URTI symptoms for scratchy throat (3 vs. 7) and cough (2 vs. 7) compared to the placebo group. CONCLUSIONS: The results of this study show Levagen+ to be safe and effective in reducing the incidence and symptoms associated with URTIs.

Libifem® (Trigonella foenum-graecum) in conjunction with exercise on muscle strength, power, endurance, and body composition in females aged between 25 and 45 years.

Introduction: This study examined the effects of Libifem® on exercise performance and body composition in females 25-45 years old. Methods: Participants were randomized to three equal groups to consume: 600 mg Libifem®/day, 300 mg Libifem®/day or a placebo for 8 weeks. Participants completed a whole-body exercise program three times a week for 8 weeks. At baseline, week 4 and week 8, muscle strength and endurance, functional threshold power, body composition, and sex hormones were measured. At week 8, all three groups increased leg press 1RM compared to baseline. Results: A significant difference between group treatment effect was seen for leg press at week 8 (p = 0.045), with the 600 mg Libifem® group significantly increasing their leg press 1RM compared to placebo (p = 0.014). The 600 mg Libifem® group significantly reduced their total fat mass (0.96 kg loss) from baseline compared to placebo group (0.09 kg gain). There was no significant difference in fat mass for the 300 mg Libifem® group (0.23 kg loss). The 600 mg Libifem® group had a significant increase in lean mass compared to both the 300 mg and placebo groups (p = 0.011 and 0.009, respectively). Discussion: Overall, there were significant and dose-related changes in body composition and ergogenic parameters, comparable with previous findings in males. Clinical Trial Registration: This trial was registered with the Australian and New Zealand Clinical Trials registry [ACTRN12618001538235].

A double-blind, randomised cross-over study to evaluate the absorption of a commercially available Ginkgo biloba extract compared to the liposomal extract Ginkgosome.

BACKGROUND: Ginkgo biloba extracts (GBE) have been used in traditional medicines for centuries. GBE has been shown to deliver protective effects against symptoms of age-related cognitive decline. Despite there being standardised extractions for GBE, there is still variability in the absorption and efficacy of different extracts. Following the development of a liposomal GBE (Ginkgosome™), the aim of this study is to investigate the absorption of the liposomal formulation compared to a comparator formulation of equal dose. METHODS: Thirteen healthy male and female volunteers completed this single equivalent dose, randomised, double-blind crossover study. Plasma concentrations were determined at baseline and at regular intervals over a 24-h period following ingestion of 120 mg of either a liposomal or comparator formulation. RESULTS: The liposomal formulation was able to increase plasma concentration of ginkgolide B and C by 1.9 and 2.2-fold compared to the comparator formulation. CONCLUSION: The novel liposomal formulation is safe in humans and demonstrates superior absorption for the supply of GBE constituents compared to a comparator standardised formulation.