RESUMEN
Euglena gracilis produce high amounts of algal ß-1,3-glucan, which evoke an immune response when consumed. This study investigated the effect of supplementation with a proprietary Euglena gracilis fermentate (BG), containing greater than 50% ß-1,3-glucan, on immune function as measured by self-reported changes in upper respiratory tract infection (URTI) symptoms. Thirty-four healthy, endurance-trained participants were randomized and received either 367 mg of BG or placebo (PLA) for 90 days. Symptoms were assessed by the 24-item Wisconsin Upper Respiratory Symptom Survey and safety via clinical chemistry, hematology, vitals, and adverse event reporting. Participants supplemented with BG over 90 days reported fewer sick days (BG: 1.46 ± 1.01; PLA: 4.79 ± 1.47 days; p = 0.041), fewer URTI symptoms (BG: 12.62 ± 5.92; PLA: 42.29 ± 13.17; p = 0.029), fewer symptom days (BG: 5.46 ± 1.89; PLA: 15.43 ± 4.59 days; p = 0.019), fewer episodes (BG: 2.62 ± 0.67; PLA: 4.79 ± 0.67; p = 0.032), and lower global severity measured as area under curve for URTI symptoms (BG: 17.50 ± 8.41; PLA: 89.79 ± 38.92; p = 0.0499) per person compared to placebo. Sick days, symptoms, and global severity were significantly (p < 0.05) fewer over 30 days in the BG group compared to PLA. All safety outcomes were within clinically normal ranges. The study provides evidence that supplementation with a proprietary Euglena gracilis fermentate containing greater than 50% ß-1,3-glucan may reduce and prevent URTI symptoms, providing immune support and protecting overall health.
Asunto(s)
Suplementos Dietéticos , Euglena gracilis , Glucanos/farmacología , Infecciones del Sistema Respiratorio/prevención & control , Adulto , Método Doble Ciego , Euglena gracilis/metabolismo , Femenino , Fermentación , Humanos , Masculino , Persona de Mediana Edad , Infecciones del Sistema Respiratorio/inmunologíaRESUMEN
Previous studies have demonstrated that chronic supplementation with a proprietary spearmint extract (PSE) can improve cognitive performance in individuals 50-70â¯years of age with age-related memory issues. In the present study, our hypothesis was that chronic supplementation of PSE would improve cognitive performance in young, active individuals. Using a randomized, double-blind, placebo-controlled, parallel design, healthy, recreationally active men and women (Nâ¯=â¯142) received 900â¯mg of PSE or placebo (PLA) daily for 90â¯days. Cognition was assessed via cognitive test battery (CNS Vital Signs) that resulted in 10 cognitive domains. Sleep, mood, and quality of life were assessed via validated questionnaires. Measurements were evaluated on days 0, 7, 30, and 90 of supplementation. Significant (Pâ¯<â¯.05) treatment effects were observed for sustained attention, wherein PSE improved sustained attention vs PLA at day 30 (PSE: 33.3⯱â¯0.54 vs PLA: 31.2⯱â¯0.98; Pâ¯=â¯.001) and day 90 (PSE: 34.0⯱â¯0.44 vs PLA: 32.7⯱â¯0.75; Pâ¯=â¯.007). Significant (Pâ¯<â¯.05) treatment × visit interactions were observed for complex attention, wherein PSE improved complex attention compared to PLA at day 7 (PSE: 8.0⯱â¯2.22 vs PLA: 7.6⯱â¯0.57; Pâ¯=â¯.016). Significant (Pâ¯<â¯.05) improvements were observed in 2 individual tests: the shifting attention test and the 4-part continuous performance test. No significant differences were observed in mood, sleep, or quality of life. The current study demonstrates that chronic supplementation with 900â¯mg of PSE improves cognitive performance in a young, active population, further supporting PSE as an efficacious nootropic.
Asunto(s)
Atención/efectos de los fármacos , Cognición/efectos de los fármacos , Suplementos Dietéticos , Mentha spicata , Nootrópicos/farmacología , Extractos Vegetales/farmacología , Adulto , Afecto/efectos de los fármacos , Método Doble Ciego , Femenino , Humanos , Masculino , Calidad de Vida , Valores de Referencia , Sueño/efectos de los fármacos , Adulto JovenRESUMEN
BACKGROUND: Proprietary spearmint extract (PSE) containing a minimum 14.5% rosmarinic acid and 24% total phenolic content, has evinced positive effects on cognition in individuals aged 50-70 with memory impairment after chronic supplementation. To address the growing interest in connecting mental and physical performance, the present study examined whether the nootropic effects of PSE translate into changes in reactive agility following daily supplementation with PSE. METHODS: Utilizing a randomized, double-blind, placebo-controlled, parallel design, healthy, recreationally-active men and women (n = 142) received 900 mg of PSE or placebo (PLA) daily for 90 days. Reactive agility, our primary outcome, was determined by measuring the number of hits and average reaction time (ART) on a Makoto Arena II, a 3600 audio-visual device that measures stationary, lateral, and multi-directional active choice reaction performance. Safety was evaluated using complete blood count, comprehensive metabolic panel, and blood lipids. Measurements were evaluated on days 7, 30, and 90 of supplementation. RESULTS: An overall treatment effect (p = 0.019) was evident for increased hits with PSE on the stationary test with footplates, with between group differences at Day 30 (PSE vs. PLA: 28.96 ± 2.08 vs. 28.09 ± 1.92 hits; p = 0.040) and Day 90 (PSE vs. PLA: 28.42 ± 2.54 vs. 27.02 ± 3.55 hits; p = 0.002). On the same task, ART improved (treatment effect, p = 0.036) with PSE at Day 7 (PSE vs. PLA: 0.5896 ± 0.060 vs. 0.6141 ± 0.073 s; p = 0.049) and Day 30 (PSE vs. PLA: 0.5811 ± 0.068 vs. 0.6033 ± 0.055 s; p = 0.049). PSE also significantly increased hits (treatment effect, p = 0.020) at Day 30 (PSE vs. PLA: 19.25 ± 1.84 vs. 18.45 ± 1.48 hits; p = 0.007) and Day 90 (PSE vs. PLA: 19.39 ± 1.90 vs. 18.66 ± 1.64 hits; p = 0.026) for the multi-directional test with footplates. Significant differences were not observed in the remaining Makoto tests. PSE was well tolerated as evidenced by no effects observed in the blood safety panels. CONCLUSIONS: The findings of the current study demonstrate that consumption of 900 mg of PSE improved specific measures of reactive agility in a young, active population. TRIAL REGISTRATION: clinicaltrials.gov, NCT02518165 . Registered August 7, 2015 - retrospectively registered.
Asunto(s)
Mentha spicata/química , Nootrópicos/farmacología , Extractos Vegetales/farmacología , Tiempo de Reacción/efectos de los fármacos , Adulto , Cinamatos , Depsidos , Femenino , Humanos , Masculino , Adulto Joven , Ácido RosmarínicoRESUMEN
OBJECTIVE: The purpose of this study was to investigate the effects of supplementation with a spearmint (Mentha spicata L.) extract, high in polyphenols including rosmarinic acid, on cognitive performance, sleep, and mood in individuals with age-associated memory impairment (AAMI). DESIGN: Subjects with AAMI (N = 90; 67% female; age = 59.4 ± 0.6 years) were randomly assigned (n = 30/group) to consume 900, 600, or 0 mg/day (two capsules, once daily) spearmint extract for 90 days, in this double-blind, placebo-controlled trial. Assessments were completed for cognition (days 0, 45, and 90), sleep (days 0 and 90), and mood (days 0 and 90) by using the Cognitive Drug Research (CDR) System™, Leeds Sleep Evaluation Questionnaire (LSEQ), and Profile of Mood States (POMS™), respectively. RESULTS: Quality of working memory and spatial working memory accuracy improved after supplementation with 900 mg/day spearmint extract by 15% (p = 0.0469) and 9% (p = 0.0456), respectively, versus placebo. Subjects consuming 900 mg/day spearmint extract reported improvement in their ability to fall asleep, relative to subjects consuming placebo (p = 0.0046). Overall treatment effects were evident for vigor-activity (p = 0.0399), total mood disturbance (p = 0.0374), and alertness and behavior following wakefulness (p = 0.0415), with trends observed for improvements after spearmint supplementation relative to placebo. CONCLUSIONS: These results suggest that the distinct spearmint extract may be a beneficial nutritional intervention for cognitive health in older subjects with AAMI.
Asunto(s)
Trastornos de la Memoria/tratamiento farmacológico , Memoria a Corto Plazo/efectos de los fármacos , Extractos Vegetales/farmacología , Extractos Vegetales/uso terapéutico , Cinamatos , Cognición/efectos de los fármacos , Depsidos , Femenino , Humanos , Masculino , Mentha spicata , Persona de Mediana Edad , Polifenoles , Sueño/efectos de los fármacos , Ácido RosmarínicoRESUMEN
The effect of potato protease inhibitor II (PI2) on postprandial appetite was examined in a randomized double-blind placebo-controlled cross-over trial involving 44 healthy women. In separate test sessions, participants consumed a capsule containing placebo or potato extract standardized to 15 or 30 mg PI2 after overnight fasting. One hour later, a standard 390 kcal breakfast was served. At regular time points during the three-hour period after breakfast, appetite was measured by visual analog scales, and blood samples were collected for assay of cholecystokinin, insulin, and glucose. Compared with the placebo, consumption of 15 mg or 30 mg PI2 one hour prior to a standard breakfast meal resulted in significantly lower postprandial hunger, desire to eat, and prospective consumption, as well as significantly higher postprandial fullness. Consumption of 15 mg PI2 also resulted in significantly higher postprandial plasma levels of cholecystokinin compared with the placebo. No significant main effect of treatment was found on insulin and glucose. No adverse events were reported. Results from the study revealed that consumption of potato PI2 at the examined doses was well tolerated, suppressed subjective appetite in a dose-dependent manner, and increased plasma concentrations of cholecystokinin. Future studies are needed to evaluate the long-term effect of PI2 on body weight.
Asunto(s)
Apetito/efectos de los fármacos , Inhibidores de Proteasas/administración & dosificación , Solanum tuberosum/química , Adolescente , Adulto , Glucemia/metabolismo , Desayuno/efectos de los fármacos , Método Doble Ciego , Femenino , Humanos , Insulina/metabolismo , Persona de Mediana Edad , Periodo Posprandial , Saciedad/efectos de los fármacos , Adulto JovenRESUMEN
Spearmint (Mentha spicata L.) and spearmint extracts are Generally Recognized as Safe (GRAS) for use as flavoring in beverages, pharmaceuticals, and confectionaries. Studies of spearmint extracts in humans and animals have reported conflicting results with respect to toxicity. Since the chemical composition of these extracts was not reported and the spearmint source material was different, the relevance of these existing data to evaluating the risks associated with ingestion of a dried aqueous spearmint extract standardized to rosmarinic acid is not clear. Hence, the safety and tolerability of the dried aqueous spearmint extract was evaluated as part of a double-blind, randomized, placebo-controlled trial in healthy adults with age-associated memory impairment. Ingestion of both 600 and 900 mg/day for 90 days had no effect on plasma levels of follicular stimulating hormone, luteinizing hormone, or thyroid stimulating hormone, or other safety parameters including vital signs, plasma chemistry or whole blood hematology values. Additionally, there were no reported severe adverse events, no significant between-group differences in the number of subjects reporting adverse effects and the adverse events reported could not be attributed to ingestion of the extract. These results therefore show that ingestion of the aqueous dried spearmint extract is safe and well-tolerated.
Asunto(s)
Aromatizantes/administración & dosificación , Aromatizantes/efectos adversos , Mentha spicata/química , Extractos Vegetales/administración & dosificación , Extractos Vegetales/efectos adversos , Productos Biológicos , Método Doble Ciego , HumanosRESUMEN
A proprietary dry spearmint extract containing 15.4% rosmarinic acid was assessed in a 90-day study with Sprague-Dawley rats that were gavaged at 0, 422 (low), 844 (mid), or 1948 (high) mg dry spearmint extract/kg bw/day, (equivalent to 0, 65, 130, or 300 mg rosmarinic acid/kg bw/day, respectively). No treatment-related clinical signs or adverse effects were observed in body weight, feed consumption, neurological parameters, hematology, clinical chemistry, gross pathology, and histopathology. However, there were statistically significant increases in the absolute and relative weight of the pituitary gland in mid- and high-dose males, absolute and relative weight of the thyroid gland in the high-dose groups of both sexes and in mid-dose males, and absolute and relative weight of the salivary glands in high-dose females compared to vehicle control group. These changes were considered non-adverse since no corresponding microscopic changes were seen. Based on these findings, the no-observed-adverse-effect level (NOAEL) for the dry spearmint extract was 1948 mg extract/kg bw/day, the highest dose tested, in Sprague-Dawley rats. In addition, the extract showed no mutagenic activity in the Ames assay using Salmonella typhimurium strains (TA98, TA100, TA102, TA1535, and TA1537) and did not induce chromosomal aberrations when tested with human peripheral blood lymphocytes.
Asunto(s)
Mentha spicata , Extractos Vegetales/administración & dosificación , Adulto , Animales , Células Cultivadas , Femenino , Humanos , Leucocitos Mononucleares/efectos de los fármacos , Masculino , Mentha spicata/efectos adversos , Extractos Vegetales/efectos adversos , Ratas , Ratas Sprague-Dawley , Pruebas de Toxicidad Aguda/métodosRESUMEN
OBJECTIVE: Prehypertensive and hypertensive individuals are at increased risk of atherosclerotic cardiovascular disease (CVD), in part because hypertension contributes to endothelial dysfunction and increased cell adhesion molecule expression. Soy protein and isoflavones may favorably alter CVD risk factors, and hence the aim of this study was to determine whether intake of cow's milk compared with soy beverage prepared from whole soy bean (WSB) or soy protein isolate (SPI) would lower soluble cell adhesion molecule concentrations as a means of decreasing CVD risk. METHODS: We enrolled healthy prehypertensive/stage 1 hypertensive men (n = 60; 18-63 years) and premenopausal women (n = 8; 20-48 years). Participants were randomized to 1 of 3 groups for 8 weeks: cow's milk (600 mL/d), SPI beverage (840 mL/d; 30.1 mg total isoflavones/d), or WSB beverage (840 mL/d; 91.4 mg total isoflavones/d). We measured soluble vascular cell adhesion molecule-1 (VCAM-1), intercellular cell adhesion molecule-1 (ICAM-1), and endothelial-leukocyte adhesion molecule-1 (E-selectin) concentrations at baseline and week 8. RESULTS: Soluble CAM concentrations were not altered by treatment and did not differ between prehypertensive and hypertensive participants. However, analysis of variance indicated a treatment × gender interaction (gender effect) for ICAM-1 (p = 0.0037) but not for E-selectin (p = 0.067) or VCAM-1 (p = 0.16). Men had higher concentrations of ICAM-1 and E-selectin, respectively, at baseline (p = 0.0071, p = 0.049) and week 8 (p = 0.0054, p = 0.038) than women did. CONCLUSION: Neither intake of cow's milk nor soy beverage for 8 weeks altered soluble CAM concentrations in prehypertensive/stage 1 hypertensive individuals, suggesting that neither type of beverage diminished atherosclerotic CVD risk in mildly hypertensive individuals by way of improving circulating CAM concentrations.