Abstract 14476: A Randomized, Double-blind Comparison Study of Royal Jelly to Improve Endothelial Function in Healthy Volunteers

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Koichiro Fujisue ◽  
Kenichi Tsujita
Keyword(s):  
Liver Function ◽  
Endothelial Function ◽  
Healthy Volunteers ◽  
Alanine Aminotransferase ◽  
Royal Jelly ◽  
Lipid Profiles ◽  
Controlled Study ◽  
Double Blind ◽  
Relative Change ◽  
Glutamyl Transpeptidase

Backgrounds: Royal jelly is a creamy substance secreted by honeybees. It has been reported that royal jelly has benefits on dyslipidemia and metabolic syndrome. However, the effects of royal jelly on atherogenesis remains unknown. We prospectively evaluated the effects of royal jelly on endothelial function, which can reflect early atherogenesis, in healthy volunteers. Methods: This was a single center, double-blind, 1:1 randomized placebo-controlled study. One-hundred healthy volunteers were randomly assigned to receive royal jelly 690 mg daily (equivalent 2040 mg of fresh royal jelly) or placebo from October 2018 and December 2019. Royal jelly or placebo were administered for 28 days. Endothelial function assessed by reactive hyperemia peripheral arterial tonometry (RH-PAT) and blood chemistries were compared between baseline and 28 days after enrollment. Primary endpoint was the change of RH-PAT index. Secondary endpoint was the change of liver function and lipid profiles. Results: The mean (SD) age of the participants was 35.0 (9.3) and 36.1 (9.1) years, and male was 45% and 50% in the placebo and the royal jelly group, respectively. The relative change of RH-PAT index was significantly higher in the royal jelly group compared with placebo control (21.4 ± 53.1% vs. 0.05 ± 40.9%, P = 0.037). The relative change of alanine aminotransferase and γ-glutamyl transpeptidase were significantly lower in the royal jelly group than the placebo group (alanine aminotransferase: –6.06 ± 22.2% vs. 11.6 ± 46.5%, P = 0.02; γ-glutamyl transpeptidase: -3.45 ± 17.8% vs. 4.62 ± 19.4%, P = 0.045). Lipid profiles were not significantly different between two study groups. Conclusions: Royal jelly improved endothelial function assessed by RH-PAT and liver function in healthy volunteer. It can be expected that royal jelly has anti-atherogenic property through improving endothelial function.

scholarly journals Effect of fermented Rhus verniciflua stokes extract on liver function parameters in healthy Korean adults: a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jung Hyun Kwak ◽  
Hyo-Jeong Lee ◽  
Seok-Tae Jeong ◽  
Ju Yeon Lee ◽  
Minho Lee ◽  
...  
Keyword(s):  
Liver Disease ◽  
Liver Function ◽  
Serum Lipid ◽  
Lipid Profiles ◽  
Controlled Study ◽  
Double Blind ◽  
Once Daily ◽  
Korean Adults ◽  
Rhus Verniciflua ◽  
Significant Difference

Abstract Background Fermented Rhus verniciflua Stokes extract (FRVE) reported an anti-hepatic lipidemic property mediated by the upregulation of AMP-activated protein kinase (AMPK) in cell and animal models. However, it remains unclear whether there is an effect of FRVE on liver disease-related parameters and serum lipid levels in humans. We investigated the effects of FRVE intake for 12 weeks on liver disease-related parameters and serum lipid profiles in Korean adults. Methods A randomized, double-blind, placebo-controlled study was conducted among 79 subjects. An aqueous extract of fermented Rhus verniciflua Stokes that was filtered and fermented was prepared. For 12 weeks, the test group (n = 39) consumed two capsules of FRVE (main components: fustin 129 mg and fisetin 59 mg) once daily. The control group (n = 40) consumed two placebo pills (main component: lactose 627.0 mg) once daily. A 1:1 randomization of control and test was performed using computer-generated randomization. Both before and after FRVE intake, anthropometric parameters, liver function-related parameters, and clinical laboratory parameters were measured. The effects between the test and control groups were compared using the Mann-Whitney U test and independent t-test, and the difference between baseline and follow-up values was compared using Wilcoxon rank-sum test and paired t-test. Results There was no significant difference when comparing the change values of liver disease-related parameters and serum lipid profiles in between groups. Conclusions In our study, we did not confirm the significance in liver function parameters and serum lipid profiles. Trial registration The study protocol was registered in the Clinical Research Information Service (CRIS: https://cris.nih.go.kr/cris/index.jsp) under number KCT0005687. Registered on 2 December 2020

Abstract 2009: ALX-0081 a Novel Anti-Thrombotic: Results of a Single-Dose Phase 1 Study in Healthy Volunteers and Further Development in Patients with Stable Angina Undergoing PCI

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Jozef Bartunek ◽  
Emanuele Barbato ◽  
Josefin-Beate Holz ◽  
Kristof Vercruysse ◽  
Hans Ulrichts ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Volunteers ◽  
Dose Escalation ◽  
Stable Angina ◽  
Thrombus Formation ◽  
Phase 1 ◽  
Controlled Study ◽  
Double Blind ◽  
Phase Ib ◽  
Wide Range

Background : ALX-0081 is a bivalent Nanobody ® based on the variable domain of naturally occurring heavy-chain only antibodies. It binds with high affinity to the A1 domain of von Willebrand Factor (vWF) and thereby blocks the interactions between platelets and vascular collagen. It selectively prevents thrombus formation under high shear stress conditions. Aim : Test ALX-0081 single IV infusions (60 minutes) dosed from 0.5mg to 12mg total in 40 male healthy volunteers in double-blind, randomized, placebo controlled study and assess pharmacokinetic (PK), pharmacodynamic (PD), safety and immunogenicity. Results : ALX-0081 displayed non-linear pharmacokinetic properties, following a 2 compartment model. Ristocetin induced platelet aggregation (RIPA) was analyzed as marker for PD effect with full inhibition (defined as measured levels dropping <10%) observed at ALX-0081 concentrations of ~ 400ng/ml. All subjects dosed ≥ 2mg achieved full RIPA inhibition at 1h post-dosing for maximum of 12h. ALX-0081 treatment was well tolerated and safe, no signs of bleeding were reported and no immunogenic response was detected. Target related mild and transient reductions of vWF and FVIII plasma levels were observed and all events were fully reversible. Phase Ib study design : double-blind, randomized, placebo controlled, multiple ascending dose study. ALX-0081 added to standard anti-thrombotic regimen (ASA, clopidogrel, UFH) in patients with stable angina undergoing elective PCI. Single-dose escalation will be followed by multiple dosing (up to 4 doses in 24h). Dose escalation will be guided by safety and efficacy marker. Endpoints: safety, pharmacological profile, biomarker (RIPA, RICO and ACT) and early clinical outcome (MACE, IMR, molecular marker). Conclusion : ALX-0081 can be administered safely over a wide range of dose-regimen. First results of the phase Ib study in stable angina patients will be presented.

Antagonism by modafinil of the psychomotor and cognitive impairment induced by sleep-deprivation in 12 healthy volunteers

1991 ◽  
Vol 6 (2) ◽  
pp. 93-97 ◽  
Author(s):  
G Bensimon ◽  
D Benoit ◽  
L Lacomblez ◽  
E Weiller ◽  
D Warot ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Sleep Deprivation ◽  
Healthy Volunteers ◽  
Controlled Study ◽  
Long Term Memory ◽  
Double Blind ◽  
Flicker Fusion Frequency ◽  
Short And Long Term ◽  
Psychotropic Compound

SummaryModafinil is a new psychotropic compound with central α1, adrenergic-stimulant activity in animals. In the present study, its pharmacological activity in man was evaluated in the sleep-deprivation induced psychomotor and cognitive impairment paradigm. This was a double-blind placebo-controlled study involving 12 healthy volunteers. Standard psychomotor and memory tasks were used, including critical flicker fusion frequency determination (CFF), choice reaction time and short- and long-term memory evaluation. Results revealed a clear antagonism by modafinil of the psychomotor and cognitive impairment induced by sleep-deprivation in most tasks 6 h after drug administration, and marginal effects 18 h after. These results therefore support a psychostimulant activity of modafinil in man.

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