scholarly journals Effect of oral intake of royal jelly on endothelium function in hemodialysis patients: study protocol for multicenter, double-blind, randomized control trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kojiro Ohba ◽  
Yasuyoshi Miyata ◽  
Takeaki Shinzato ◽  
Satoshi Funakoshi ◽  
Kanenori Maeda ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Endothelial Function ◽  
Royal Jelly ◽  
Treatment Initiation ◽  
Controlled Trial ◽  
Vascular Endothelial Cell ◽  
Oral Intake ◽  
Cerebrovascular Diseases ◽  
Double Blind ◽  
Endothelium Function

Abstract Background Hemodialysis (HD) is a common renal replacement therapy for patients with renal failure. Cardiovascular and cerebrovascular diseases are known to shorten survival periods and worsen the quality of life of HD patients. Atherosclerosis is a major cause of vascular diseases, and various factors such as abnormality of lipid metabolism and increased macrophage activity, oxidative stress, and endothelial dysfunction are associated with its pathogenesis and progression. Further, endothelial stem cells (ESCs) have been reported to play important roles in endothelial functions. Royal jelly (RJ) affects atherosclerosis- and endothelial function-related factors. The main aim of this trial is to investigate whether oral intake of RJ can maintain endothelial function in HD patients. In addition, the effects of RJ intake on atherosclerosis, ESC count, inflammation, and oxidative stress will be analyzed. Methods This will be a multicenter, prospective, double-blind, randomized controlled trial. We will enroll 270 participants at Nagasaki Jin Hospital, Shinzato Clinic Urakami, and Maeda Clinic, Japan. The participants will be randomized into RJ and placebo groups. The trial will be conducted according to the principles of the Declaration of Helsinki, and all participants will be required to provide written informed consent. The RJ group will be treated with 3600 mg/day of RJ for 24 months, and the placebo group will be treated with starch for 24 months. The primary endpoint will be the change in flow-mediated dilation (FMD), a parameter of endothelium function, from the time before treatment initiation to 24 months after treatment initiation. The secondary and other endpoints will be changes in FMD; ESC count; serum levels of vascular endothelial cell growth factor, macrophage colony-stimulating factor, 8-hydroxydeoxyguanosine, and malondialdehyde; the incidence of cardiovascular diseases, cerebrovascular diseases, and stenosis of blood access; and safety. Discussion This trial will clarify whether oral intake of RJ can maintain endothelial function and suppress the progression of atherosclerosis in HD patients. In addition, it will clarify the effects of RJ on ESCs, oxidative stress, and angiogenic activity in blood samples. Trial registration The Japan Registry of Clinical Trials jRCTs071200031.  Registered on 7 December 2020.

scholarly journals Lipid Lowering Therapy with Combination of Niacin and Statin in Women: Age-Related Endothelial Effects

2013 ◽  
Vol 2013 ◽  
pp. 1-7
Author(s):  
Beth Parker ◽  
Kamlesh Kothawade ◽  
Namee Kim ◽  
Maura Paul-Labrador ◽  
Noel Bairey Merz ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Vascular Function ◽  
Controlled Trial ◽  
Pearson Correlation ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Cardiac Events ◽  
Double Blind ◽  
Lowering Therapy ◽  
Age Related

Background. Many women remain at risk for cardiac events despite treatment to reduce low-density lipoprotein cholesterol (LDL-C). We hypothesized that for postmenopausal women treated with niacin in addition to statin vascular function will improve. Methods. We conducted a randomized, double-blind, placebo-controlled trial of 16 weeks of niacin (N) versus placebo (PL) in 43 women (mean age, 67±9 years) previously on statin therapy. Study outcomes included lipoprotein levels, vascular inflammation assessed by high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), and endothelial function, assessed as brachial artery flow mediated dilation (FMD). Results. The N group significantly increased HDL-C and decreased LDL-C cholesterol relative to PL (both P<0.01). FMD improved in both groups (P=0.02) irrespective of niacin (P=0.21). Age influenced change in FMD (P=0.01) such that improved FMD (before to after) with lipid lowering therapy was greater with older age (P=0.03 Pearson correlation = 0.34), independent of treatment group. Conclusions. Lipid lowering therapy with combination of niacin and statin does not improve inflammation or endothelial function compared to statin alone. However, older women demonstrate relatively greater endothelial benefit of lipid lowering therapy over 4 months. This trial is registered with Clinicaltrials.gov NCT00590629.

scholarly journals Acute Effects of Triiodothyronine on Endothelial Function in Human Subjects

2007 ◽  
Vol 92 (1) ◽  
pp. 250-254 ◽  
Author(s):  
Raffaele Napoli ◽  
Vincenzo Guardasole ◽  
Valentina Angelini ◽  
Emanuela Zarra ◽  
Daniela Terracciano ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Dose Response ◽  
Vascular Reactivity ◽  
Controlled Trial ◽  
University Hospital ◽  
Acute Effects ◽  
Response Curves ◽  
Double Blind ◽  
Low T3 ◽  
Dose Response Curves

Abstract Context: Thyroid hormone regulates several cardiovascular functions, and low T3 levels are frequently associated with cardiovascular diseases. Whether T3 exerts any acute and direct effect on endothelial function in humans is unknown. Objective: Our objective was to clarify whether acute changes in serum T3 concentration affect endothelial function. Design, Setting, and Subjects: Ten healthy subjects (age, 24 ± 1 yr) participated in a double-blind, placebo-controlled trial at a university hospital. Interventions: T3 (or placebo) was infused for 7 h into the brachial artery to raise local T3 to levels observed in moderate hyperthyroidism. Vascular reactivity was tested by intraarterial infusion of vasoactive agents. Main Outcome Measures: We assessed changes in forearm blood flow (FBF) measured by plethysmography. Results: FBF response to the endothelium-dependent vasodilator acetylcholine was enhanced by T3 (P = 0.002 for the interaction between T3 and acetylcholine). The slopes of the dose-response curves were 0.41 ± 0.06 and 0.23 ± 0.04 ml/dl·min/μg in the T3 and placebo study, respectively (P = 0.03). T3 infusion had no effect on the FBF response to sodium nitroprusside. T3 potentiated the vasoconstrictor response to norepinephrine (P = 0.006 for the interaction). Also, the slopes of the dose-response curves were affected by T3 (1.95 ± 0.77 and 3.83 ± 0.35 ml/dl·min/mg in the placebo and T3 study, respectively; P &lt; 0.05). The increase in basal FBF induced by T3 was inhibited by NG-monomethyl-l-arginine. Conclusions: T3 exerts direct and acute effects on the resistance vessels by enhancing endothelial function and norepinephrine-induced vasoconstriction. The data may help clarify the vascular impact of the low T3 syndrome and point to potential therapeutic strategies.

scholarly journals The Effect of Tribulus Terrestris Supplementation on Inflammation, Oxidative Stress and Performance of Recreational Runners: Study Protocol for a Double-Blind Randomized Controlled Trial

2021 ◽  
Author(s):  
Marzieh Nejati ◽  
Parvin Dehghan ◽  
Mostapha Khani
Keyword(s):  
Oxidative Stress ◽  
High Intensity ◽  
Controlled Trial ◽  
Sport Performance ◽  
Tribulus Terrestris ◽  
Double Blind ◽  
Inflammatory Status ◽  
Recreational Runners ◽  
Anti Inflammatory ◽  
Exercise Induced

Abstract Background: High intensity and endurance exercises lead to exercise-induced oxidative stress (EIOS), exercise-induced muscle damage (EIMD), and inflammation, which are the influencing factors on muscle soreness, localized swelling, and sport performance. Therefore, the purpose of this study is to determine the effectiveness of Tribulus terrestris (TT) as an herbal supplement with antioxidant and anti-inflammatory properties on the nutritional, oxidative stress, and anti/inflammatory status, as well as the sport performance of recreational runners.Methods/design: This study is a double-blind, randomized, placebo-controlled trial, which will be conducted among recreational runners of Tabriz stadiums, Iran. Thirty-four recreational runners will be selected, and participants will be assigned randomly to two groups: to receive 500 mg TT supplement or placebo capsules twice daily for two weeks. Both groups will do the high-intensity interval training (HIIT) workouts during the study. Baseline and post-intervention body composition, muscle fatigue, and soreness parameters will be assessed. In addition, assessment of malondialdehyde (MDA), total antioxidant capacity (TAC), superoxide dismutase (SOD), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), creatine kinase (CK), lactate dehydrogenase (LDH), insulin-like growth factor-1 (IGF-1) and brain-derived neurotrophic factor (BDNF) will be done during three blood samplings.Discussion: This study will be the first to assess the potential effects of TT in recreational runners. Our results will contribute to the growing body of knowledge regarding TT supplementation on the nutritional, oxidative stress, anti/inflammatory status and sport performance in recreational runners.Trial registration: Iranian Registry of Clinical Trials (www.irct.ir) (ID: IRCT20150205020965N8). Registration date: 13 February 2021.

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