scholarly journals Evaluation of the equivalence of different intakes of Fruitflow in affecting platelet aggregation and thrombin generation capacity in a randomized, double-blinded pilot study in male subjects

BMC Nutrition ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ranjit K. Das ◽  
Tanushree Datta ◽  
Dipankar Biswas ◽  
Ruedi Duss ◽  
Niamh O’Kennedy ◽  
...  
Keyword(s):  
Pilot Study ◽  
Thrombin Generation ◽  
Daily Intake ◽  
Adenosine Diphosphate ◽  
Water Soluble ◽  
Initial Assessment ◽  
Platelet Response ◽  
Generation Capacity ◽  
Double Blinded ◽  
Male Subjects

Abstract Background The water-soluble tomato extract, Fruitflow® is a dietary antiplatelet which can be used to lower platelet aggregability in primary preventative settings. We carried out a pilot study to investigate the range of intakes linked to efficacy and to make an initial assessment of variability in response to Fruitflow®. Methods Platelet response to adenosine diphosphate (ADP) agonist and thrombin generation capacity were monitored at baseline and 24 h after consuming 0, 30, 75, 150 or 300 mg of Fruitflow® in a randomized, double-blinded crossover study in male subjects 30–65 years of age (N = 12). Results were evaluated for equivalence to the standard 150 mg dose. Results Results showed that the changes from baseline aggregation and thrombin generation observed after the 75 mg, 150 mg, and 300 mg supplements were equivalent. Aggregation was reduced from baseline by − 12.9 ± 17.7%, − 12.0 ± 13.9% and − 17.7 ± 15.7% respectively, while thrombin generation capacity fell by − 8.6 ± 4.1%, − 9.2 ± 3.1% and − 11.3 ± 2.3% respectively. Effects observed for 0 mg and 30 mg supplements were non-equivalent to 150 mg and not different from baseline (aggregation changed by 3.0 ± 5.0% and − 0.7 ± 10.2% respectively, while thrombin generation changed by 0.8 ± 3.0% and 0.8 ± 3.1% respectively). Conclusions The data suggest that the efficacious range for Fruitflow® lies between 75 mg and 300 mg, depending on the individual. It may be pertinent to personalize the daily intake of Fruitflow® depending on individual platelet response. Trial registration ISRCTN53447583, 24/02/2021.

scholarly journals Evaluation of the Equivalence of Different Intakes of Fruitflow® in Affecting Platelet Aggregation and Thrombin Generation Capacity in a Randomized, Pilot Study in Male Subjects

2021 ◽  
Author(s):  
Ranjit K Das ◽  
Tanushree Datta ◽  
Dipankar Biswas ◽  
Ruedi Duss ◽  
Niamh O'Kennedy ◽  
...  
Keyword(s):  
Thrombin Generation ◽  
Daily Intake ◽  
Water Soluble ◽  
Initial Assessment ◽  
Platelet Response ◽  
Tomato Extract ◽  
Generation Capacity ◽  
The Individual ◽  
Double Blinded ◽  
Male Subjects

Abstract BackgroundWe aimed to investigate the range of intakes linked to efficacy and to make an initial assessment of variability in response to the water-soluble tomato extract, Fruitflow®. Platelet response to ADP agonist and thrombin generation capacity were monitored at baseline and 24h after consuming 0,30,75,150,300mg of Fruitflow® in a randomized, double-blinded crossover study in male subjects 30–65 years of age (n=12, ISRCTN53447583,24/02/2021). ResultsResults showed that the changes from baseline aggregation (-12.0±13.9 to -17.7±15.7%) and thrombin generation (-8.6±4.1 to -11.3±2.3%) achieved for the 75mg, 150mg, and 300mg supplements were equivalent. Effects observed for 0 mg and 30mg supplements were non-equivalent to150mg and not different from baseline (aggregation changed by -0.7±10.2 to 3.0±5.0%, thrombin generation by 0.8±3.1%). ConclusionsThe data suggest that the efficacious range for Fruitflow® lies between 75mg and 300mg, depending on the individual. It may be pertinent to personalize the daily intake of Fruitflow® depending on individual platelet response.

Effects of PYY3–36 and GLP-1 on energy intake, energy expenditure, and appetite in overweight men

2014 ◽  
Vol 306 (11) ◽  
pp. E1248-E1256 ◽  
Author(s):  
Julie Berg Schmidt ◽  
Nikolaj Ture Gregersen ◽  
Sue D. Pedersen ◽  
Johanne L. Arentoft ◽  
Christian Ritz ◽  
...  
Keyword(s):  
Energy Expenditure ◽  
Synergistic Effect ◽  
Energy Intake ◽  
Fat Metabolism ◽  
Vital Signs ◽  
Healthy Male ◽  
Double Blinded ◽  
Male Subjects ◽  
Infusion Period ◽  
Blood Variables

Our aim was to examine the effects of GLP-1 and PYY3–36, separately and in combination, on energy intake, energy expenditure, appetite sensations, glucose and fat metabolism, ghrelin, and vital signs in healthy overweight men. Twenty-five healthy male subjects participated in this randomized, double-blinded, placebo-controlled, four-arm crossover study (BMI 29 ± 3 kg/m2, age 33 ± 9 yr). On separate days they received a 150-min intravenous infusion of 1) 0.8 pmol·kg−1·min−1 PYY3–36, 2) 1.0 pmol·kg−1·min−1 GLP-1, 3) GLP-1 + PYY3–36, or 4) placebo. Ad libitum energy intake was assessed during the final 30 min. Measurements of appetite sensations, energy expenditure and fat oxidation, vital signs, and blood variables were collected throughout the infusion period. No effect on energy intake was found after monoinfusions of PYY3–36 (−4.2 ± 4.8%, P = 0.8) or GLP-1 (−3.0 ± 4.5%, P = 0.9). However, the coinfusion reduced energy intake compared with placebo (−30.4 ± 6.5%, P < 0.0001) and more than the sum of the monoinfusions ( P < 0.001), demonstrating a synergistic effect. Coinfusion slightly increased sensation of nausea ( P < 0.05), but this effect could not explain the effect on energy intake. A decrease in plasma ghrelin was found after all treatments compared with placebo (all P < 0.05); however, infusions of GLP-1 + PYY3–36 resulted in an additional decrease compared with the monoinfusions (both P < 0.01). We conclude that coinfusion of GLP-1 and PYY3–36 exerted a synergistic effect on energy intake. The satiating effect of the meal was enhanced by GLP-1 and PYY3–36 in combination compared with placebo. Coinfusion was accompanied by slightly increased nausea and a decrease in plasma ghrelin, but neither of these factors could explain the reduction in energy intake.

Glycyrrhizic acid: the assessment of a no effect level

2000 ◽  
Vol 19 (8) ◽  
pp. 434-439 ◽  
Author(s):  
C E M van Gelderen ◽  
J A Bijlsma ◽  
W van Dokkum ◽  
T J F Savelkoull
Keyword(s):  
Body Weight ◽  
Pilot Study ◽  
Glycyrrhizic Acid ◽  
Mild Hypertension ◽  
Daily Intake ◽  
Long Term Effects ◽  
Healthy Female ◽  
The Usa ◽  
Effect Level

Because from earlier experiments in rats and a pilot study in humans a no effect level of glycyrrhizic acid could not be established, a second experiment was performed in healthy volunteers. The experiment was performed in females only, because the effects were most marked in females in the pilot study. Doses of 0, 1, 2 and 4 mg glycyrrhizic acid/kg body weight were administered orally for 8 weeks to 39 healthy female volunteers aged 19-40 years. The experimentlasted 12 weeks including an adaptation and a “wash-out” period.Ano-effectlevel of2 mg/kgis proposed from the results ofthis study, from which an acceptable daily intake (ADI) of 0.2 mg/kg body weight can be extrapolated with a safety factor of 10. This means consumption of 12 mg glycyrrhizic acid/day for a person with a body weight of 60 kg. This would be equal to 6 g licorice a day, assuming that licorice contains 0.2% of glycyrrhizic acid. The proposed ADI is below the limit advised by the Dutch Nutrition Council of 200 mg glycyrrhizic acid/day. This reflects the relatively mild acute toxicity of glycyrrhizic acid, which is also emphasised by the “generally recognised as safe” (GRAS) status of glycyrrhizic acid in the USA in 1983. However, the long-term effects of a mild chronic intoxication (causing, for example, a mild hypertension), although not immediately lethal, justify special attention to the amount of glycyrrhizic acid used daily.

Silicon Resorption from Equisetum arvense Tea – A Randomized, Three-Armed Pilot Study

Planta Medica ◽  
2021 ◽  
Author(s):  
Moritz Winker ◽  
Amy Marisa Zimmermann-Klemd ◽  
Seema Devi ◽  
Aljoscha Waterstradt ◽  
Ann-Kathrin Lederer ◽  
...  
Keyword(s):  
Pilot Study ◽  
Folk Medicine ◽  
Significant Rise ◽  
Equisetum Arvense ◽  
Immunological Parameters ◽  
Silicon Accumulation ◽  
Immunological Effects ◽  
Blood And Urine Samples ◽  
High Concentrations ◽  
Male Subjects

Abstract Equisetum arvense tea (TEA) contains high concentrations of silicon and has been used in folk medicine for the treatment of inflammatory ailments. We examined the resorption of silicon after TEA consumption. Safety and immunological effects were secondary outcomes. A monocentric, randomized, three-armed pilot study was conducted with 12 voluntary, healthy, male subjects. The study is registered in the German register for clinical trials (DRKS-ID: DRKS00016628). After a low silicon diet for 36 hours, 1000 mL TEA1 with approximately 200 000 µg silicon/L, TEA2 with approximately 750 000 µg silicon/L, or Si-low-Water (approximately 10 – 10 000 µg silicon/L as a control) were ingested on three consecutive days. Blood and urine samples were collected at baseline, day 1 examining silicon kinetics, day 3 examining silicon accumulation, and day 8 (safety, immunological parameters). Si-low-Water intake did not change silicon serum (Cmax 294 µg/L) or urine (19 000 µg/24 h) concentrations compared to baseline. Cmax was 2855 µg/L for TEA1 and 2498 µg/L for TEA2; tmax was 60 and 120 min, respectively. Silicon accumulation did not occur. Urine silica within 24 h (E24 h) was higher after TEA2 compared to TEA1 ingestion (142 000 vs. 109 000 µg/24 h). Serum silicon levels at t = 120 min differed significantly after intake of TEA2 or intake of Si-low-Water (p = 0.029). The immunological parameters did not show any significant changes indicating immunosuppressive effects in volunteers. TEA1 was well tolerated, while TEA2 caused diarrhoea in 4 subjects. Our investigations show that intake of TEA1 leads to significant rise in serum silicon concentration.

Abstract P683: Thrombin Generation in Plasma of Stroke Patients With Atrial Fibrillation

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Sarina Falcione ◽  
Gina Sykes ◽  
Joseph Kamtchum Tatuene ◽  
Danielle Munsterman ◽  
Twinkle Joy ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Thrombin Generation ◽  
Thrombus Formation ◽  
Lag Time ◽  
Thrombin Time ◽  
Stroke Patients ◽  
Time To Peak ◽  
Generation Capacity

Background and Purpose: Thrombus formation is central to pathophysiology of stroke in patients with atrial fibrillation. Whether factors in plasma contribute to thrombus generation in patients with atrial fibrillation remains unclear. In this study we sought to determine whether plasma contributes to thrombin generation in patients with atrial fibrillation. Methods: There were 78 acute ischemic strokes with atrial fibrillation and 37 non-stroke controls. Plasma thrombin generation was measured by thrombin generation assay, resulting lag time, peak thrombin, time to peak and area under the curve was assessed. Thrombin generation capacity was compared in stroke patients with atrial fibrillation to non-stroke controls. The relationship to anticoagulation was assessed. In vitro, the effect of anticoagulation on plasma thrombin generation was determined. Results: Thrombin generation capacity was increased (shorter lag time and time to peak) in ischemic stroke patients with atrial fibrillation compared to non-stroke atrial-fibrillation controls (p<0.05 and p<0.01, respectively). Anticoagulation decreased plasma induced thrombin generation. Ischemic stroke patients with atrial fibrillation treated with anticoagulation (DOAC or warfarin) had lower plasma induced thrombin generation compared to atrial-fibrillation patients not on anticoagulation (p<0.05). Thrombin generation by plasma could be further reduced by DOAC in an in-vitro assay. Conclusions: Stroke patients with atrial fibrillation have a higher plasma induced thrombin generation compared to atrial fibrillation controls. Factors in plasma such as leukocyte derived tissue factor likely contribute to thrombus formation in patients with atrial fibrillation. As such, components in plasma may represent new targets to reduce thrombus formation and stroke risk in patients with atrial fibrillation.

scholarly journals Standard manual reprocessing of angiographic systems in the hybrid OR

2017 ◽  
Vol 3 (2) ◽  
pp. 405-407
Author(s):  
Sebastian Buhl ◽  
Carina Werner ◽  
Clemens Bulitta
Keyword(s):  
Pilot Study ◽  
Medical Devices ◽  
Initial Assessment ◽  
Hybrid Operating Room ◽  
Medical Products ◽  
Fda Guidance ◽  
Microbiological Examination ◽  
Artis Zeego ◽  
Cleaning And Disinfection ◽  
A Current

AbstractA current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.

scholarly journals Use of doxycycline for leptospirosis after high-risk exposure in São Paulo, Brazil

1998 ◽  
Vol 40 (1) ◽  
pp. 59-61 ◽  
Author(s):  
Claudio R. GONSALEZ ◽  
Jorge CASSEB ◽  
Francisco G. V. MONTEIRO ◽  
João B. PAULA-NETO ◽  
Rufino B. FERNANDEZ ◽  
...  
Keyword(s):  
Pilot Study ◽  
Treated Group ◽  
Sao Paulo ◽  
Risk Exposure ◽  
São Paulo ◽  
High Exposure ◽  
Igm Antibodies ◽  
Igm Antibody ◽  
Double Blinded ◽  
Number Of Individuals

A clinical trial pilot study, double-blinded, randomized, and controlled with a placebo to assess the effectiveness of oral doxycycline (200 mg, single dose) in preventing leptospirosis after high exposure to potentially contamined water was performed in São Paulo, SP, Brazil. Confirmed cases were defined as those with leptospira IgM antibody and symptoms; asymptomatic cases were those presenting with IgM antibodies but no symptoms; and suspected cases were individuals with symptoms but no IgM antibody. Forty subjects were given doxycycline and 42 were given placebo. In the drug-treated group there were 2 confirmed cases, 11 asymptomatic cases, and 6 suspected cases. In the placebo group there were 5 confirmed, 6 symptomatic, and 5 suspected cases. Even though we found a protective association of doxycycline for confirmed leptospirosis cases (RR = 2.3) and seroconversion only (RR = 2.0), the association was not statistically significant because of the small number of individuals enrolled in this pilot study. We observed that the 22% of the volunteers already had IgM antibodies to leptospirosis at the first sampling. Finally, the attack rate to confirmed, asymptomatic, and suspected cases of Leptospirosis was 8.5%, 22%, and 13%, respectively, in this population.

scholarly journals Thrombopoietin in Patients With Congenital Thrombocytopenia and Absent Radii: Elevated Serum Levels, Normal Receptor Expression, But Defective Reactivity to Thrombopoietin

Blood ◽  
1997 ◽  
Vol 90 (2) ◽  
pp. 612-619 ◽  
Author(s):  
Matthias Ballmaier ◽  
Harald Schulze ◽  
Gabriele Strauβ ◽  
Klara Cherkaoui ◽  
Nicole Wittner ◽  
...  
Keyword(s):  
Elevated Serum ◽  
Signal Transduction Pathway ◽  
Adenosine Diphosphate ◽  
Serum Levels ◽  
Receptor Expression ◽  
Healthy Controls ◽  
Transduction Pathway ◽  
Platelet Response ◽  
Tar Syndrome

The pathophysiology of thrombocytopenia in the syndrome of thrombocytopenia with absent radii (TAR) is not yet understood. We examined thrombopoietin (TPO) serum levels and the in vitro reactivity of platelets to TPO in five patients affected with TAR syndrome. We found elevated TPO serum levels in all patients tested, excluding a TPO production defect as cause for thrombocytopenia in TAR syndrome. In addition, we found similar expression of the TPO receptor c-Mpl on the surface of platelets from TAR patients (5 of 5) and a similar molecular weight of the receptor as compared with healthy controls (4 of 4). Platelet response to adenosine diphosphate or thrombin receptor agonist peptide SFLLRN (TRAP) was normal in TAR patients. However, in contrast to results with healthy controls we could show absence of in vitro reactivity of platelets from TAR patients to recombinant TPO as measured by testing TPO synergism to adenine diphosphate and TRAP in platelet activation. TPO induced tyrosine phosphorylation of platelet proteins was completely absent (3 of 4) or markedly decreased (1 of 4). Our results indicate that defective megakaryocytopoiesis/thrombocytopoiesis in TAR syndrome is not caused by a defect in TPO production but a lack of response to TPO in the signal transduction pathway of c-Mpl.

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