I. INTRODUCTION 3 II. SCIENTIFIC & CLINICAL RESEARCH 4-8 III. MANUFACTURING PROCESS 9 IV. BIBLIOGRAPHY 10
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1 Rhodiol WHITEPAPER
2 INDEX I. INTRODUCTION 3 II. SCIENTIFIC & CLINICAL RESEARCH 4-8 III. MANUFACTURING PROCESS 9 IV. BIBLIOGRAPHY 10 Nektium Pharma S.L. All rights reserved. Rhodiolife is a registered brands owned by Nektium. This publication contains information of general nature only. While Nektium has used reasonable efforts to include accurate and up-to-date information, Nektium does not make any warranties or representations as to its accuracy. To the maximum extent permitted by law, Nektium does not assume any liability or responsibility for the reliability, accuracy, validity, usefulness or completeness of any information in this document. Reliance on this document is done solely at the risk of the reader. Rev
3 I. INTRODUCTION Nektium is the global market leader in the production of affordable and outstanding quality Rhodiola rosea. Dr. Zakir Ramazanov first noticed the endurance enhancing effects of this powerful adaptogen when he was serving as an officer in the Russian army in Afghanistan and soon after demobilization he pioneered its use in the Western world. SUPERIOR RAW MATERIAL Nektium is one of a few select companies that are authorized by a special permit issued by the Russian Government to export Rhodiola rosea from the pristine Altai Mountains in Siberia with a loyal supplier relationship that spans almost 15 years. Good collection practices ensure that only older roots are harvested and repeat harvesting from the same locality is done on a 5-year rotation to allow sustainable re-establishment of the wild plant populations. Nektium audits the collection process and storage facilities on site in Siberia on a regular basis. GUARANTEED BIOACTIVES AND BOTANICAL ORIGIN Nektium is a specialist in the importation of high quality, DNA identity-confirmed Rhodiola rosea roots and guarantees conformity of Rhodiolife extracts with specifications for salidrosides and three rosavins individually quantified by UHPLC. AFFORDABLE Because we have managed the supply chain of our Rhodiola rosea roots from the Altai for more than fifteen years and maintain close personal relationships with our exclusive suppliers we are able to offer you affordable prices. Rhodiol What is Rhodiolife? Rhodiolife is Nektium s standardized extract of Rhodiola rosea roots and is available in two different specifications: 3% total rosavins and salidrosides > 1%, and 5% total rosavins and salidrosides >1.8%. How does Rhodiolife work? Rhodiolife is a powerful adaptogen that produces a non-specific state of adaptation and resistance in the body to physical, emotional and environmental stress. Rhodiolife is experiential, thereby offering a distinct advantage over other adaptogens, and even a single dose provides activation of mental energy and improved focus. Nektium Rhodiolife 3
4 I. INTRODUCTION ACTIVE PRINCIPLES OF RHODIOLIFE The adaptogenic activity of Rhodiola rosea is usually attributed to the presence of four principal active ingredients: salidroside, rosin, rosavin and rosarin. Rhodiola rosea roots Rhodiolife UHPLC chromatogram of Rhodiola rosea root compared with our Rhodiolife extract. Bioactive compounds (1) salidroside (2) rosarin (3) rosavin (4) rosin Chemical structures of the main bioactive compounds in Rhodiola rosea roots. Nektium Rhodiolife 4
5 II. SCIENTIFIC AND CLINICAL RESEARCH 1. MENTAL ENERGY While many studies on various extracts and formulations of Rhodiola rosea have demonstrated benefits in diverse models of physical and psychological stress 1, Nektium pioneered the investigation of the Central Nervous System (CNS) activities of Rhodiolife using cuttingedge neurophysiological studies including in vivo functional electroencephalogram (EEG). In a preclinical study, a single dose of Rhodiolife was demonstrated to result in a very rapid onset of brain activation on EEG, an effect that had a long duration of action, lasting at least five hours. The EEG signature was shown to be very similar to the signatures for caffeine, Guarana (Paullinia cupana) and Ginkgo biloba 2. Spectral power [% of pre-drug baseline] 5-65 min min min min min EEG Rhodiolife Front. cortex δ ϑ α1 α2 β1a β1b β2 ϒ Hippocampus δ ϑ α1 α2 β1a β1b β2 ϒ A second approach for the pharmacological characterization of botanical preparations involves elucidating the direct action on brain matter. For this purpose, we used an in vitro hippocampal slice preparation from adult rats. In vitro Long-Term Potentiation (LTP) studies in the hippocampus were performed and changes of population spike amplitude as a consequence of Single stimuli challenge (SS) and Theta burst stimulation (TBS) were recorded. Rhodiolife increases LTP 3, an effect related to improvements in spatial and temporal memory that enables the brain to form memories and helps athletes to automate coordination skills 4. Amplitude [mv] Increased Long-Term Potentiation Rhodiola TBS Rhodiola SS mg/l Nektium Rhodiolife 5
6 II. SCIENTIFIC AND CLINICAL RESEARCH 2. MOOD In a Pilot study of Rhodax, a marketed finished product containing Nektium s Rhodiolife, 10 participants diagnosed with Generalized Anxiety Disorder (GAD) received a daily dose of 340mg for 10 weeks, had significantly reduced Hamilton Anxiety Rating Scale (HARS) scores 5. Rhodiola rosea rhizome was studied in two randomized, double-blind, placebo-controlled trials of 146 subjects with major depressive disorder and seven open-label studies totaling 714 individuals with stress-induced mild depression. The results of these studies suggest a possible antidepressant action for Rhodiola rosea extract 6. muscle tissue of healthy untrained volunteers during exercise 12. Protection of skeletal muscle from cell damage and oxidative stress after bicycle ergometer exercise Rhodax (Rhodiolife ) was studied in a randomized controlled clinical trial, where 36 healthy untrained volunteers were divided into 3 groups (control, placebo and Rhodiolife ). Individuals received placebo or 340mg of Rhodiolife for 30 days before and 6 days after exhausting physical exercise. In the group treated with Rhodiolife, CRP increases were smaller than in the control and placebo groups and had returned to normal levels five days after exercise. 3. NEUROPROTECTION Reports have indicated neuroprotective potential for Rhodiola rosea 7. The effect of Rhodiolife on genes related to neurodegeneration and neuroprotection was tested in the cholinergic neuroblastoma cell line NS20Y. The gene modulation profile showed a significant upregulation (p<0.05) of 3 GPCR-genes, suggesting a possible role for Rhodiolife in neuroprotection 8. As expected the mean CK level in the blood increased significantly after exhausting physical exercise in all groups, and five days after exercise, the CK activity in the Rhodiolife -treated group was significantly lower than in the placebo and control groups. Thus, treatment of untrained volunteers with Rhodiolife reduced inflammation, evidenced by decreased CRP, CK and muscle damage. Reduced CRP levels 1,6 4. ANTI-INFLAMMATORY ACTIVITY In a study performed in rats, an ethanolic Rhodiola rosea extract inhibited formaldehydeinduced arthritis and nystatin-induced paw oedema in a dose-dependent manner. The results demonstrated that Rhodiola rosea decreases inflammation and reduces COX-2 9. mg/l 1,2 0,8 0,4 0 Before test 5h post Reduced CK levels 5d post SPORT & MUSCLE HEALTH Rhodiolife protects muscle cells against oxidative stress 10, improves physical work capacity, assists recovery 11 and protects the U/ml Before test 5h post 5d post Control Placebo Rhodiolife compared to baseline compared to 5h after test compared to controls/placebo) Nektium Rhodiolife 6
7 II. SCIENTIFIC AND CLINICAL RESEARCH 6. IMPROVED ENDURANCE EXERCISE PERFORMANCE The effect of acute Rhodiola rosea intake on physical capacity, muscle strength and speed of limb movement was tested in a double-blind randomized placebo-controlled study (200 mg, 3% rosavin + 1% salidroside, n= 24). Rhodiola rosea intake increased time to exhaustion (p <0.05) and VO2 max (p <0.05) indicating that Rhodiola rosea can improve endurance exercise capacity in healthy young volunteers 13. A second study analyzed the effect of Rhodiola rosea on endurance exercise performance and perceived exertion in a double-blind, random crossover manner (3 mg/kg, n = 18) in a bicycle ergometer trial. Perceived exertion (RPE) was measured every 5 minutes. Subjects completed the trial significantly faster after Rhodiola rosea ingestion and the mean RPE was lower. Acute Rhodiola rosea ingestion appeared to improve endurance exercise performance by decreasing the perception of effort 14. increase the muscle content of several Hsp proteins, contributing to muscle regeneration and recovery 15. While additional work is needed to confirm the findings, recent data suggest that Rhodiolife modifies the production of Hsp70 in muscle cells under conditions of increased oxidative stress, such as that caused by intense physical exercise and protects muscles from stress related damage 10. Cell cultures without Rhodiolife pre-treatment showed a 25 % decrease in cell viability following exposure to H 2 O 2, while no significant decrease in cell viability was detected in cells pre-treated with Rhodiolife. Rhodiolife increases expression of HSP70 genes. HSP70 protein levels were maintained in cell cultures pre-treated with Rhodiolife but were significantly lower (-50%) in cells exposed to H 2 O 2, without Rhodiolife treatment (p = 0.05 compared to control). 7. IMPROVED PHYSICAL WORKING CAPACITY AND RECOVERY Comparison of Rhodiola rosea and Rhodiola crenulate showed that Rhodiola rosea is more effective than Rhodiola crenulata at improving physical work capacity. The effect of Rhodiola rosea supplementation on ATP content in muscles was studied in rats that ingested Rhodiola rosea (50 mg/kg bw) and Rhodiola crenulata (50 mg/kg bw) in a forced swim test 11. The results suggest that rosavins, only present in Rhodiola rosea, may be responsible for the improved physical work capacity and recovery. Hsp70 (ng/mg protein) Protection of HSP70 p = 0.05 Control Rhodiolife Rhodiolife H 2 O 2 + H 2 O 2 8. HEAT SHOCK PROTEIN HSP70 IMPROVES MUSCLE PROTECTION AND RECOVERY The expression of heat shock proteins (Hsps) is one of the essential stress reactions of cells. Acute endurance and resistance protocols Nektium Rhodiolife 7
8 9. POSSIBLE IMMUNE SUPPORT IN SPORTS Reduced virus replication Ground-breaking studies led by Dr. David Nieman, director of the Appalachian State University Human Performance Laboratory at the NC Research Campus (NCRC) in Kannapolis, demonstrated that in the presence of serum from Rhodiolife and placebo supplemented subjects, Rhodiolife protects against virus replication (p = 0.013). These findings suggest that that bioactive compounds in the serum of subjects ingesting Rhodiolife may be protective against virus replication following intense and prolonged exercise, a finding that needs verification in future studies 16. Geometric Mean Fluorescence Rhodiolife Pre-race serum Placebo p = min post-race serum Nektium Rhodiolife 8
9 II. SCIENTIFIC AND CLINICAL RESEARCH CONCLUSION An extensive scientific literature has validated many of the traditional Siberian uses of Rhodiola rosea roots including for adaptogenic, mental energy and endurance-enhancing effects. Nektium and partners have built on this impressive research base with preclinical and clinical studies on Rhodiolife that have demonstrated rapid onset of brain-activating activity, increased Long-Term Potentiation, anxiolytic and antidepressant potential, antiinflammatory and neuroprotective activity, enhanced physical work capacity and recovery, and skeletal muscle protective activity. Rhodiolife is a highly versatile experiential adaptogen that can be used in your mental energy, mood, nootropic and sports performance products. Nektium Rhodiolife 9
10 III. MANUFACTURING PROCESS DNA BARCODING: IDENTIFICATION OF SPECIES Botanical raw material first undergoes macroscopic inspection to ensure it conforms with reference plant material. DNA barcoding by the Royal Botanical Garden, Madrid, is used to positively confirm its botanical identity. Additionally, UHPLC chromatographic profiles are used to confirm the presence of characteristic markers and to quantify the content. CERTIFICATIONS Rhodiolife is the result of high quality botanical raw material and meticulous manufacturing procedures. Nektium s facilities and production processes strictly comply with cgmp (independently audited and certified annually) and rigorous quality control programs that ensure a high quality product. Nektium Pharma S.L. is authorized by the Spanish Health & Food Agency for the production of botanical and fruit extracts in conformance with RD 1712/1991 and Spanish Regulations. Nektium Pharma S.L. also holds a FSSC22000 Food Safety System Certification by NSF International. Nektium Rhodiolife 10
11 IV. BIBLIOGRAPHY 1. Khanum, F., Singh, A. & Singh, B. Rhodiola rosea : 4, (2005). Modulating Heat Shock Protein 70 (HSP70) Expression. Phytother. Res. 28, (2014). 2. Dimpfel, W., Schombert, L., Vega-morales, T., Wiebe, J. C. & Giessen, J. Neuropharmacological Characterization of Extracts from Rhodiola rosea, Oenothera paradoxa and Paullinia cupana in Comparison to Caffeine (2016). 3. Dimpfel, W. Drug Discovery and Translational Medicine Based on Neurophysiological Techniques. A holistic approach to saving animals. (Books on Demand, Norderstedt, BoD, 2015). 4. Patten, A. R. et al. Long-term exercise is needed to enhance synaptic plasticity in the hippocampus. Learn. Mem. 20, (2013). 5. Bystritsky, A., Kerwin, L. & Feusner, J. D. A Pilot Study of Rhodiola rosea (Rhodax ) for Generalized Anxiety Disorder (GAD). J. Altern. Complement. Med. 14, (2008). 6. Amsterdam, J. D. & Panossian, A. G. Rhodiola rosea L. as a putative botanical antidepressant. Phytomedicine 23, (2016). 7. Nabavi, S. F. et al. Rhodiola rosea L. and Alzheimer s Disease: From Farm to Pharmacy. Phyther. Res. 30, (2016). 11. Abidov, M., Crendal, F., Grachev, S., Seifulla, R. & Ziegenfuss, T. Effect of extracts from Rhodiola rosea and Rhodiola crenulata (Crassulaceae) roots on ATP content in mitochondria of skeletal muscles. Bull. Exp. Biol. Med. 136, (2003). 12. Abidov, M., Grachev, S., Seifulla, R. D. & Ziegenfuss, T. N. Extract of Rhodiola rosea radix reduces the level of C-reactive protein and creatinine kinase in the blood. Bull. Exp. Biol. Med. 138, (2004). 13. De Bock, K., Eijnde, B. O., Ramaekers, M. & Hespel, P. Acute Rhodiola rosea intake can improve endurance exercise performance. Int. J. Sport Nutr. Exerc. Metab. 14, (2004). 14. Noreen, E., Buckley, J. & Lewis, S. The effects of an acute dose of Rhodiola rosea on exercise performance and cognitive function. J. Int. Soc. Sports Nutr. 6, P14 (2009). 15. Morton, J., Kayani, A., McArdle, A. & Drust, B. The exercise induced stress respose of skeletal muscle, with specific emphasis on humans. Sport. med 39, (2009). 8. Zubeldia, J., Hernandez-Sanatana, A., Jiménez del Rio, M. & Pérz-López, V. In Vitro and in Silico Evaluation of the Potential for Neuroprotection of Rhodiolife, A Rhodiola Rosea Roots Extract. J. Food Stud. 2, (2013). 16. Ahmed, M. et al. Rhodiola rosea Exerts Antiviral Activity in Athletes Following a Competitive Marathon Race. Front. Nutr. 2, 1 7 (2015). 9. Pooja, Bawa, A. S. & Khanum, F. Antiinflammatory activity of Rhodiola rosea- a second-generation adaptogen. Phytother. Res. 23, (2009). 10. Hernández-Santana, A., Pérez-López, V., Zubeldia, J. M. & Jiménez-Del-Rio, M. A Rhodiola Rosea Root Extract Protects Skeletal Muscle Cells Against Chemically Induced Oxidative Stress by Nektium Rhodiolife 11
12 C/ Las Mimosas 8, Agüimes. Las Palmas. Spain Nektium Pharma S.L. All rights reserved. Zynamite is a registered brands owned by Nektium. This publication contains information of general nature only. While Nektium has used reasonable efforts to include accurate and up-to-date information, Nektium does not make any warranties or representations as to its accuracy. To the maximum extent permitted by law, Nektium does not assume any liability or responsibility for the reliability, accuracy, validity, usefulness or completeness of any information in this document. Reliance on this document is done solely at the risk of the reader. Rev
I. INTRODUCTION 3 IV. REGULATORY 7 VI. BIBLIOGRAPHY 8
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