Pycnogenol for stress relief -
The year long, peer-reviewed study conducted at Chieti-Pescara University in Italy and published in the December Journal of Neurosurgical Sciences , included 77 participants between ages 55 — 70, all of whom were generally fit and followed a healthy lifestyle but, had high levels of oxidative stress.
Fred Pescatore. What I found compelling about this study is the measurable effect Pycnogenol® had on the adult participants in relation to memory, attention span and ability to manage everyday tasks. Those who took Pycnogenol in this study reported feeling more focused while making decisions and stronger when it came to tasks like dealing with people and managing finances.
According to a survey conducted by the CDC ¹ , one in eight boomers report confusion and memory loss more often.
Of these people, one-third reported that confusion or memory loss interfered with their work, social activities or ability to do household chores. The health plan involved a regular sleep regimen of at least eight hours per night, balanced meals with reduced caffeine, salt and sugar intake, and regular exercise.
Center for Disease Control. While there is no single solution to improved cognitive function, lifestyle patterns — including adequate amounts of sleep, diet and daily exercise routines have shown to increase attention span and improve mood.
We continue to see a significant performance with Pycnogenol® in reducing oxidative stress and how that factors into improving overall cognitive function. Gianni Belcaro, lead researcher of the study. Results of the study were measured using an Informant Questionnaire on Cognitive Decline in the elderly IQ Code , daily tasks, cognitive function, oxidative stress and the short Blessed tests SBT to evaluate cognitive functions COFU.
Pescatore also noted study findings on improving mood and quality of sleep. To review clinical research and additional information on Pycnogenol®, visit www.
Pycnogenol® is available in more than dietary supplements and multi-vitamins worldwide. These worsen the condition of trauma and delay the recovery by producing oxidative stress and matrix metalloproteinases [ 13 , 14 ].
These post-traumatic inflammatory cascades cause blood—brain barrier BBB dysfunction, which ultimately leads to the influx of inflammatory cells from the blood to the brain [ 15 ].
Production of reactive oxygen substrates ROS directly or indirectly, as oxidative by-products of lipids, proteins, or nucleic acids are common following traumatic brain injury.
Malondialdehyde MDA is the major by-products of lipid peroxidation. MDA is potentially an atherogenic lipid peroxide and generated in vivo via peroxidation of polyunsaturated fatty acids [ 16 ].
Nutritional support is an important issue in intensive care for critically ill patients such as those with TBI. Patients with TBI often remain in a hypermetabolic state where the energy expenditure is increased [ 17 ].
Early nutrition support in TBI patients results in a significant reduction in mortality rate, less infectious complications, and lower risk of poor outcome [ 18 ]. There has been a growing use of immunonutrition to modulate the inflammatory response in injury or infection and to improve clinical outcomes [ 19 ].
Immune-modulation enteral formula has been proven to significantly reduce infection rate in TBI patients [ 20 ]. One of the ingredients that can be used in an immunonutrition formula to reduce inflammation and oxidative stress is pycnogenol.
Pycnogenol® PYC is recognized as one of the most powerful natural antioxidants, which is a bark extract of the French maritime pine Pinus pinaster and is rich in flavonoids. The main components of PYC are: polyphenols, specifically mono- and oligomeric units of caffeic acid, ferulic acid, catechin, epicatechin, and taxifolin [ 21 ].
It is classified as GRAS generally recognized as safe in the USA [ 22 ]. Clinical effects of PYC include endothelium-dependent vasodilator activity [ 23 ] and anti-thrombotic effect as shown by numerous in vitro and in vivo investigations in animals and human clinical research studies [ 21 , 24 ].
PYC prevents neurotoxicity and apoptotic cell death in oxidative stress status [ 25 , 26 ]. Also, PYC protects against lipid peroxidation and pro-oxidants and peroxynitrites [ 27 , 28 ].
A number of animal studies have proven the protective effect of PYC following traumatic brain injury by suppressing IL-6 and TNF-α levels [ 29 , 30 ].
No serious adverse effects have been seen in any clinical trials or commercial use [ 31 ]. The most commonly observed adverse effect is gastric discomfort due to its mild and transient nature [ 22 ]. Recently, we conducted a systematic review and meta-analysis of clinical trials that used PYC in chronic diseases [ 32 ].
Our meta-analysis revealed that PYC supplementation may have beneficial effects on glycolipid metabolism by reducing fasting glucose, HbA1c, LDL, and enhancing HDL. Also, PYC reduced CRP, plasma-free radicals, systolic and diastolic blood pressure, and body mass index.
In this study, for the first time in the world we aimed to assay the PYC effect on inflammatory markers and clinical status in acute phase in humans.
Previous human studies have reported the neuroprotective and anti-inflammatory effects of PYC. The effect of PYC to reduce neuroinflammation in TBI rat has also been proven. So the main objective of the present study is to study the effect of PYC on the clinical, nutritional, and inflammatory status of TBI patients as the first human study in the world.
In achieving this overall goal, numerous issues will be addressed with the specific objective of providing definitive answers to the following questions: 1 Is PYC effective in reducing the inflammatory markers including IL-6, IL-1β, and CRP C-reactive protein in TBI patients in an intensive care unit?
This is a parallel-group randomized trial. Blocked randomization will be used to allocate eligible participants to either the control group or the intervention group. The study framework is superiority. All TBI patients admitted directly or transferred to the intensive care units of the participating hospital will be evaluated for eligibility for entry into the randomized clinical trial.
Preliminary eligibility criteria are summarized in Table 1. Patients meeting all preliminary eligibility criteria are considered potentially eligible for the study. Patients are screened for the presence of any specific exclusion criteria which would preclude study entry. These exclusions are designed to eliminate patients for whom participation may be dangerous or patients with serious medical disorders whose impact on operative outcome may obscure the importance of nutritional, clinical, and inflammatory factors.
These are summarized in Table 2. Sample-size calculations were based upon Luzzi et al. Assuming a probable drop out of the sample, 30 patients in each group will be considered. A study evaluating the effect of PYC on IL-6 and TNF-α in TBI was an animal study [ 29 ] and inappropriate for the human sample-size calculation.
Therefore, we used CRP as an inflammatory factor to calculate the sample size. However, for more certainty, we calculated the sample size according to Hakumat Rai et al. ʼs study [ 17 ] based on IL-6 change in TBI patients. Also this committee will review data from the trial. The trial sponsor will undertake auditing of the trial procedure.
We will randomly allocate eligible patients on enrolment [ 1 ] to either the control group or the intervention group. The randomization list of unique patient identifiers is generated by the computer-generated random block size site. Nutritionists or clinicians will keep the sealed opaque envelope containing the unique patient identifier and the study group allocation in a locked cabinet in the study laboratory.
They will be opened by the second nutritionist. Investigators, all study staff hospital attending clinical teams, and patients will be masked to the study group allocation.
A pragmatic [ 34 ], parallel-group, double-blind, randomized controlled trial Table 3 will be conducted. We will enroll 60 patients who are admitted to the ICU at a university hospital in Tehran, Iran. All participants or their first-degree relatives will need to provide informed consent to the clinician before participating.
Participants will be randomly divided into two groups. The method of randomization and masking are explained above. The capsules will be given by the investigator to the patients by gavage, so fidelity to the intervention will be strong.
However, for more certainty, at the end of each day, the number of capsules remaining for each patient will be checked. In order to control the confounding effect of food intake, both the control group and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.
There have been no reports of serious adverse events in any clinical trials or commercial use of OLIGOPIN. However, these patients will be regularly evaluated biochemically and clinically each day, and the liver function tests including serum levels of ALT alanine aminotransferase and AST aspartate aminotransferase will be checked.
Data will be collected at four main times: at baseline, at the 5th day of intervention, at the 10th day of intervention, and at the day follow-up visit. At baseline, demographic characteristics are gathered via a questionnaire.
The serum sample will be isolated and used to measure the markers via ELISA kits. APACHE ІІ for assessment of clinical status of patients and NUTRIC questionnaires for assessment of nutritional status will be filled out at the base line, 5th day, and the end of study.
The SOFA questionnaire for assessment of organ failure will be filled out every other day. A SPIRIT diagram of the recommended content for the schedule of enrolment, interventions, and assessments is shown in Fig. SPIRIT diagram of recommended content for the schedule of enrolment, interventions, and assessments.
Completed forms will be stored as the source documentation in a locked cabinet, with access restricted to specified study team members. The forms will be identified by a unique participant ID number and will not contain any patient identifiable information.
Queries based on data in the database will be generated daily, including date, range, and logic checks. The measurable outcomes are summarized in Table 4. The trial profile will be summarized using a CONSORT flow chart, including reasons for non-eligibility and non-enrolment [ 35 ].
The objective of this clinical trial is to determine if PYC supplementation improves clinical and nutritional outcomes in TBI patients admitted to an ICU or not. To answer this question, the outcomes of patients receiving PYC supplements will be compared with the outcomes of patients receiving placebo.
All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis, and adjusted for randomization site. Thus, all randomized patients who will receive at least one dose of study treatment and who will have both a baseline and at least one post-baseline measurement will be analyzed.
Statistical analyses will be conducted with SPSS version 19 SPSS Institute, Chicago, IL, USA. Chi-square test will be done for categorical variables. t test will be done to assess the statistical significance of the continuous variables.
Comparable nonparametric test Mann—Whitney U test will be substituted when tests for normality and equal variance failed. Survival analysis will be performed with log-rank test. The study design flow diagram is summarized in Fig. More details about the statistical analyses plan is presented in Additional file 2.
Patients will be screened and randomly enrolled into the intervention and control groups based on age, gender, and APACHE II score. Adding Oligopin to a nutritional formula might reduce neuroinflammation and oxidative stress and improve clinical and nutritional status in TBI patients. However, human study about PYC Oligopin in this patient group has not been done so far.
It is assumed that oxidative stress mediated through the superoxide radical superoxide and other reactive oxygen species ROS may be principal to inflammation and impaired neural function [ 36 ].
The acute inflammatory response differs in early and late stages of TBI; too much inflammation for too long delays recovery [ 37 ]. Shortly after brain injury, there is mass production of proinflammatory cytokines, such as IL-1β, IL-6, and CRP [ 38 ].
In the event of TBI, IL-1β is the most studied cytokine. Glial cells produce IL-1β and affect neurons and other brain cells. IL-1β motivates inflammatory responses and aggregates immune cells, disrupts the BBB, and forms edema, and leads to loss of neurons [ 39 ].
The high level of IL-1β has been detected in CSF and brain tissue within the early hours of a brain injury in humans as well as in experimental animals [ 39 ]. Administration of anti-IL-1β antibodies decreased edema and degradation of brain tissue.
A previous study reported improvement of cognitive function in rats following TBI [ 40 ]. There are similar findings for IL Intervention to mitigate IL-6 in animals with mild TBI triggers normal brain function and reduces the effects of hypoxia aggravation of inflammation of brain damage [ 41 ].
In TBI patients, CRP levels are correlated with the duration of hospitalization in an ICU and dependence on a ventilator, and the severity of the damage [ 42 ]. Finally, we selected these inflammatory factors as outcomes of the study.
On the other hand, the duration of intervention used in clinical trials to evaluate the clinical effects of PYC supplementation has varied from several hours to several months [ 22 , 45 , 46 ].
No side effects have been reported with this dose. gov ref: NCT on December 17, , and is ongoing. It is the first version of the protocol. In April , recruitment began, and the anticipated date to complete the study is February Final study datasets will be stored locally and securely at Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran, for long-term storage and access.
Participant-level data will be made available by request on a case-by-case basis. All Principal Investigators will access to the data sets. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information.
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Epidemiology of traumatic brain injury in Europe. Acta Neurochir. Article PubMed Google Scholar. Abdul-Muneer P, Chandra N, Haorah J. Interactions of oxidative stress and neurovascular inflammation in the pathogenesis of traumatic brain injury. Mol Neurobiol.
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Google Scholar. Roozenbeek B, Maas AI, Menon DK. Changing patterns in the epidemiology of traumatic brain injury. Nat Rev Neurol. Menon D, Schwab K, Wright D, Maas A. Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health.
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Gaetz M. Of these people, one third reported that confusion or memory loss interfered with their work, social activities or ability to do household chores. The health plan involved a regular sleep regimen of at least 8 hours per night, balanced meals with reduced caffeine, salt and sugar intake, and regular exercise.
Although there is no single solution to improved cognitive function, lifestyle patterns - including adequate amounts of sleep, diet and daily exercise routines - have shown to increase attention span and improve mood. In the study, after 12 months of daily supplementation with Pycnogenol, results were shown to.
We continue to see a significant performance with Pycnogenol in reducing oxidative stress and how that factors into improving overall cognitive function.
This research adds to a body of science for Pycnogenol, demonstrating its benefits for adults, ages 55 and older,' said Dr Gianni Belcaro, lead researcher of the study. Results of the study were measured using an Informant Questionnaire on Cognitive Decline in the elderly IQ Code , daily tasks, cognitive function, oxidative stress and the short Blessed tests SBT to evaluate cognitive functions COFU.
Dr Pescatore also noted study findings on improving mood and quality of sleep. As science shows, the better quality of sleep we get, the better cognitive function we have as we age,' said Pescatore.
Home Ingredients Study shows daily use of Pycnogenol can improve attention span, decision making and memory for baby boomers.
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Protection from pine! Pycnogenol, derived from the bark of pine trees from France, is Pycnogenll source of very potent polyphenols including procyanidins and phenolic acids. Gluten-free Vitamin Supplement Berry Baking Ideas are produced by plants rwlief defense mechanisms Reloef pathogens and predators. Adding product to your cart. In southern France, the beautiful and lush forests are home to a species of French pine trees Pinus pinaster that contain unique health-promoting properties. Its use dates back to the s when French explorer Jacques Cartier and his sailors struggled with scurvy — frank vitamin C deficiency — during their long sailing voyages from France to the New World. Trials volume 21Article reluef Cite this article. Metrics details. Phcnogenol brain injury TBI Pycnogenol for stress relief one of Gluten-free Vitamin Supplement major Energy-enhancing shakes and socioeconomic problems strfss the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patients. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is pycnogenol. The objective of this work is to survey the effect of pycnogenol on the clinical, nutritional, and inflammatory status of TBI patients. This is a double-blind, randomized controlled trial.
sogar so
Es ist leichter, zu sagen, als, zu machen.
Logisch, ich bin einverstanden
Absolut ist mit Ihnen einverstanden. Darin ist etwas auch mich ich denke, dass es die ausgezeichnete Idee ist.