BIA research studies -
BIA [1] actually determines the electrical impedance , or opposition to the flow of an electric current through body tissues which can then be used to estimate total body water TBW , which can be used to estimate fat-free body mass and, by difference with body weight, body fat. Many of the early research studies showed that BIA was quite variable and it was not regarded by many as providing an accurate measure of body composition.
In recent years [ when? Although the instruments are straightforward to use, careful attention to the method of use as described by the manufacturer should be given.
Simple devices to estimate body fat, often using BIA, are available to consumers as body fat meters. These instruments are generally regarded as being less accurate than those used clinically or in nutritional and medical practice.
Dehydration is a recognized factor affecting BIA measurements as it causes an increase in the body's electrical resistance , so has been measured to cause a 5 kg underestimation of fat-free mass i.
an overestimation of body fat. Body fat measurements are lower when measurements are taken shortly after consumption of a meal, causing a variation between highest and lowest readings of body fat percentage taken throughout the day of up to 4.
Moderate exercise before BIA measurements lead to an overestimation of fat-free mass and an underestimation of body fat percentage due to reduced impedance. body fat is significantly underestimated.
BIA is considered reasonably accurate for measuring groups, of limited accuracy for tracking body composition in an individual over a period of time, but is not considered sufficiently accurate for recording of single measurements of individuals. Consumer grade devices for measuring BIA have not been found to be sufficiently accurate for single measurement use, and are better suited for use to measure changes in body composition over time for individuals.
Multiple electrodes, typically eight, may be used located on the hands and feet allowing measurement of the impedance of the individual body segments - arms, legs and torso.
The advantage of the multiple electrode devices is that body segments may be measured simultaneously without the need to relocate electrodes. Results for some impedance instruments tested found poor limits of agreement and in some cases systematic bias in estimation of visceral fat percentage, but good accuracy in the prediction of resting energy expenditure REE when compared with more accurate whole-body magnetic resonance imaging MRI and dual-energy X-ray absorptiometry DXA.
Impedance is frequency sensitive; at low frequency the electric current flows preferentially through extracellular water ECW only while at high frequency the current can cross cell membranes and hence flows through total body water TBW. In bioimpedance spectroscopy devices BIS resistance at zero and infinite frequency can be estimated and, at least theoretically, should provide the optimal predictors of ECW and TBW and hence body fat-free mass respectively.
In practice, the improvement in accuracy is marginal. The use of multiple frequencies or BIS in specific BIA devices has been shown to have high correlation with DXA when measuring body fat percentage.
The electrical properties of tissues have been described since These properties were further described for a wider range of frequencies on a larger range of tissues, including those that were damaged or undergoing change after death.
In , Thomasset conducted the original studies using electrical impedance measurements as an index of total body water TBW , using two subcutaneously inserted needles. In , Hoffer concluded that a whole-body impedance measurement could predict total body water. The equation the squared value of height divided by impedance measurements of the right half of the body showed a correlation coefficient of 0.
This equation, Hoffer proved, is known as the impedance index used in BIA. In , Nyober validated the use of whole body electrical impedance to assess body composition. By the s the foundations of BIA were established, including those that underpinned the relationships between the impedance and the body water content of the body.
A variety of single-frequency BIA analyzers then became commercially available, such as RJL Systems and its first commercialized impedance meter.
In the s, Lukaski, Segal, and other researchers discovered that the use of a single frequency 50 kHz in BIA assumed the human body to be a single cylinder, which created many technical limitations in BIA.
The use of a single frequency was inaccurate for populations that did not have the standard body type. To improve the accuracy of BIA, researchers created empirical equations using empirical data gender, age, ethnicity to predict a user's body composition.
In , Lukaski published empirical equations using the impedance index, body weight, and reactance. In , Kushner and Scholler published empirical equations using the impedance index, body weight, and gender.
However, empirical equations were only useful in predicting the average population's body composition and was inaccurate for medical purposes for populations with diseases. The use of multiple frequencies would also distinguish intracellular and extracellular water. By the s, the market included several multi-frequency analyzers and a couple of BIS devices.
The use of BIA as a bedside method has increased because the equipment is portable and safe, the procedure is simple and noninvasive, and the results are reproducible and rapidly obtained.
More recently, segmental BIA has been developed to overcome inconsistencies between resistance R and the body mass of the trunk.
In , an eight-polar stand-on BIA device, InBody , that did not utilize empirical equations was created and was found to "offer accurate estimates of TBW and ECW in women without the need of population-specific formulas.
In , AURA Devices brought the fitness tracker AURA Band with built-in BIA. In BIA became available for Apple Watch users with the accessory AURA Strap with built-in sensors.
The impedance of cellular tissue can be modeled as a resistor representing the extracellular path in parallel with a resistor and capacitor in series representing the intracellular path, the resistance that of intracellular fluid and the capacitor the cell membrane. This results in a change in impedance versus the frequency used in the measurement.
Whole body impedance measurement is generally measured from the wrist to the ipsilateral ankle and uses either two rarely or four overwhelmingly electrodes. In the 2-electrode bipolar configuration a small current on the order of μA is passed between two electrodes, and the voltage is measured between the same whereas in the tetrapolar arrangement resistance is measured between as separate pair of proximally located electrodes.
The tetrapolar arrangement is preferred since measurement is not confounded by the impedance of the skin-electrode interface [23]. In bioelectrical impedance analysis in humans, an estimate of the phase angle can be obtained and is based on changes in resistance and reactance as alternating current passes through tissues, which causes a phase shift.
A phase angle therefore exists for all frequencies of measurement although conventionally in BIA it is phase angle at a measurement frequency of 50 kHz that is considered. The measured phase angle therefore depends on several biological factors.
Phase angle is greater in men than women, and decreases with increasing age. Contents move to sidebar hide. In the multiple dose ascending part, the doses were 2.
The severe adverse events were observed in the 50 mg dose group. The ANSM expert committee reported [15] that complete FAAH inhibition should have been achieved by a dose of 1. Further, the ANSM committee remarked that the gap between the 20 mg and 50 mg dose cohorts, in effect, skipped a dose based on extrapolation from the single dose part of the study, and that the progression to 50 mg was too large a jump.
On reviewing the subject data from the trial itself, the committee noted that BIA showed non-linear pharmacokinetics at doses between 40 and mg that is, the molecule appeared to be accumulating at higher doses and that most likely the elimination mechanism had become saturated.
Thus dosing at 50 mg daily was - each day - 40 times more than required to achieve complete inhibition, and in practice this dose level resulted in accumulation.
According to Bial and the Rennes University Hospital, by the time the serious adverse reactions emerged, subjects had been recruited and 84 other volunteers had received the drug during the trial, with no serious adverse events being reported.
fasting part, and the first four dose groups of the multi-dose part of the study had each been completed in Notably, the administration of 20 mg BIA once daily for 10 consecutive days elicited no serious adverse events in the six volunteers who received it.
Dosing of eight volunteers in the highest multi-dose group in the BIA trial commenced on 6 January Six of the participants received 50 mg per day of the drug while two received placebo. On the following day, the other subjects received a 6th dose at am before the trial was suspended later that day 11 January.
The fifth dose level 50 mg per day for 10 days of the multi-dose part of study had been underway for five days when the first volunteer became ill and was hospitalized at the Rennes University Hospital on the evening of 10 January with symptoms similar to a stroke.
All the MRI findings, though widely varying in severity, were of the same form and seen in the hippocampus and pons of the affected individuals. The men who were hospitalised were all from the group which received the highest dose of the multiple ascending part of the trial.
A neurologist at the University of Rennes Hospital Center, Professor Pierre-Gilles Edan, stated in a press conference with the French Minister for Health, that 3 of the 4 men who were displaying neurological symptoms "already have a severe enough clinical picture to fear that even in the best situation there will be an irreversible handicap" and were being given corticosteroids to control the inflammation.
The man who died was later named by local news media as Guillaume Molinet, 49, an artist and father of four from Guilliers, a town in the Breton department of Morbihan.
Molinet's family said they were originally told he had had a stroke that was unrelated to the clinical trial, though this quickly turned out not to be the case. The events in Rennes were made public on 15 January [1] [3] [4] and were reported widely in the media in France, [41] [42] [43] internationally in mainstream news [44] [45] [46] [47] and scientific media.
The journal Nature quoted Bial spokeswoman Susana Vasconcelos as saying the trial had been conducted "in accordance with all the good international practices guidelines, with the completion of tests and preclinical trials" and that "the company is committed to determine thoroughly and exhaustively the causes which are at the origin of this situation".
The journal also sought comment from Jean-Marc Gandon, the president and chief executive of the CRO Biotrial, who said "he cannot immediately respond to queries from Nature, that he is focused on trying to save the patients and that the company will respond later".
As of March it remained unclear whether Bial disclosed the adverse animal findings to Biotrial, including the deaths of monkeys and dogs in several studies. François Peaucelle, the director general of Biotrial, is reported to have told Le Figaro. From that data, there was nothing worrying in view of the dosage we were administering to humans.
The Agence Nationale de Sécurité du Médicament ANSM announced an investigation, and that an inspection of the trial site was already underway.
The ONIAM Office National d'Indemnisation des Accidents Médicaux , responsible for medical injury compensation, stated only 10 accidents had occurred during clinical trials over the past 15 years per its records, and that those cases had "consequences infinitely less serious" than the incident in Rennes.
Initial reports from the authorities suggested that the causes of the brain injuries was likely to be due to the mechanism of BIA and the doses employed in the trial. In May , the French Health Minister announced several new measures for clinical trials in France, including the establishment of an expert group within the ANSM for review of first in human and early phase studies.
The Inspection générale des affaires sociales IGAS released a preliminary report on 5 February The Minister announced that all clinical trials in France in the event of a serious, unexpected adverse event such as this would be explicitly required to re-consent the remaining trial participants.
Biotrial published a detailed response on its website, expressing its disappointment to learn of the report via the media and not prior to its publication from the Health Ministry.
CHU informed Biotrial at am on 11 January that the man had likely had a stroke , at which point the trial was halted, though it was not known whether the stroke had anything to do with the study drug. This was after further doses had been given to the other volunteers at am that morning.
Biotrial's statement offered no comment on the time taken between the trial halt at am on the 11th and the notification of the authorities three days later on the 14th. The committee also criticised the clinical study design which "probably significantly contributed to the accident", noting that administration of the top multi-dose groups did not and could not take into account emerging pharmacokinetic data from latest dose groups and offered no chance to adjust the dose as adverse events emerged.
The choice of dose escalation levels 20 to 50 to mg was based on pharmacokinetic data from the 10 mg group and data from the 50 mg dose group that would have clearly shown non-proportional dose kinetics were not yet available when administration to the mg multi-dose group commenced.
The committee made six recommendations, which it invited European and International regulators to consider reproduced here in brief :. A European Medicines Agency EMA spokesperson said in January that "EU authorities will look carefully at the findings to determine if further measures are needed to protect health of clinical trial participants.
Until EU authorities have the full picture, it is not possible to say whether any revisions to EU guidelines are required". The European Investment Bank , which provided million euros in funding for Bial's FAAH inhibitor programme stated it had been in contact with the company about the incident, but that "it would be premature to consider recall of the EIB loan at this stage".
The US Food and Drug Administration issued a statement that it was in contact with its counterparts the ANSM as well as the EMA and announced investigations into FAAH inhibitors as a drug class.
FDA will work with sponsors to ensure the safety of participants in clinical studies and take regulatory action as appropriate. The German drug regulator, the Bundesinstitut für Arzneimittel und Medizinprodukte BfArM issued a statement 19 January that no clinical trials with FAAH inhibitors were underway in Germany, but that it had authorised seven such trials previously, which were completed without serious incidents.
The Rennes University Hospital provided updates on the remaining volunteers in the study and the treating specialists later published a medical report describing the sickened volunteers in November in The New England Journal of Medicine.
The authors were of the view that "the toxic effects we observed were related to drug accumulation. This hypothesis is supported by the nonlinear pharmacokinetics of BIA for doses higher than 40 to mg" and as reported by the ANSM's expert committee.
The authors were not however granted access to information from the post-mortem of the man who died. News reports from March described the condition of Stéphane Schubhan 42 , a professional photographer from La Flèche , Sarthe and participant of the top dose cohort. Schubhan "sleeps badly, has nightmares, sees double at all times, walks with difficulty, and succumbs to dizziness and nausea if he stands more than 10 minutes at a time" and does not know if he will be able to work again.
Schubhan said he had participated in a previous clinical trial, but in this case he was never informed about the animal deaths that were later revealed and would never have consented to take part had he known.
Doctors have told Schubhan that they hope he will improve over the coming 6—12 months but that they do not know what the outcome will be [26]. In , Mr. Schubhan was convicted and sentenced to 30 years jail for the attempted murder of his partner and children's mother, whom he was planning to leave.
Under French Law, all clinical trial participants are protected by the Huriet Law on the protection of persons in clinical research. The BIA trial participants are therefore entitled to financial compensation as well as recourse to civil and criminal proceedings.
Following the events in Rennes, Janssen announced that it was temporarily suspending dosing in two Phase II clinical trials with its own FAAH inhibitor, JNJ , headlining the decision as "precautionary measure follows safety issue with different drug in class".
Janssen was emphatic that no serious adverse events had been reported in any of the clinical trials with JNJ to date. Janssen did not state whether the suspension, though voluntary, was at the request of the FDA. Pfizer had previously been developing an FAAH inhibitor PF for indications including osteoarthritis pain and trauma.
A spokesperson commented after the events in Rennes that "we [Pfizer] did explore the potential of a FAAH-inhibitor for osteoarthritic pain in Phase 2 trials, however, no significant efficacy was observed. The FAAH-inhibitor was recently being evaluated in Post-Traumatic Stress Disorder but this trial was discontinued in for business reasons.
We do not have any active trials in this area". Sanofi also had been developing an FAAH inhibitor candidate SSR for the treatment of depression. However, a spokesperson stated in January that "we have no projects in development that target this enzyme".
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January Learn how and when to remove this template message. Archived from the original on 22 January Retrieved 21 January Le contenu du test du Bia 10 — de Bial révélé [exclusif]".
Retrieved 17 January Agence Nationale de Sécurité du Médicament, France ANSM. Archived from the original on Retrieved Ministère des Affaires Sociales, de la Santé et des Droits des Femmes, France. Archived from the original on 20 January University Hospital Rennes.
Archived from the original PDF on 3 February Retrieved 18 January Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM. Retrieved 22 May Retrieved 18 May Retrieved 22 Jan — via ANSM. doi : PMC PMID Expert Opinion on Drug Discovery.
S2CID Retrieved 29 January Archived from the original on 12 March Retrieved 10 March Collaborative Chemistry Forum.
Retrieved 5 February org; Biomedical Research Forum. Retrieved 5 January Agence Nationale de Sécurité du Médicament et des Produits de Santé.
Le Figaro. Retrieved 23 January Inspection générale des affaires sociales. February The Lancet. Science Media Centre, London. European Medicines Agency. Retrieved 22 January In-Pharma Technologist. Retrieved 15 March The Irish Times. Retrieved 17 March Science Magazine.
Nature News. Royal Statistical Society. Retrieved 28 January Archived from the original on 6 February Retrieved 6 February La Depeche. January 15, Retrieved January 18, Retrieved January 16, BBC News. L'Edition du Soir Ouest France.
Channel 4 News. Le Monde. Le frère de la victime : "Je lui ai dit de ne pas le faire" ". Le Dauphine. Une mort cérébrale, cinq hospitalisés". Retrieved 24 January The Guardian. ABC, AP. Retrieved 16 January New Scientist.
Público Portugal. Bibcode : Natur. Archived from the original on 26 February Retrieved 19 January The Guardian Online.
Use a Studifs Scale to Meet Studied BIA research studies Weight Loss Goals. Anisha BBIA, MD, is a board-certified Hydration for post-workout recovery, interventional Body mass index, and fellow of the American College studeis Cardiology. Adah Vegan weight loss an occupational therapist, working in the area of pediatrics with elementary students with special needs in the schools. Her work as an occupational therapist includes: home health, acute care, chronic care, seating and positioning, outpatient rehab, and skilled nursing rehab. Bioelectrical impedance analysis BIA measures body composition based on the rate at which an electrical current travels through the body. Studiws BIA research studies with BIAA human endocannabinoid system. The chemical name of BIA studdies 3- desearch Hydration for post-workout recovery methyl carbamoyl -1H-imidazolyl pyridine 1-oxide. In normal tissues, the Injury prevention exercises for young athletes FAAH degrades anandamide and other endocannabinoid neurotransmitterswhich Vegan weight loss pain and can affect eating and sleep patterns. FAAH inhibitors have been proposed for a range of nervous system disorders including anxiety disordersalcoholismpain and nausea. The Portuguese pharmaceutical company Bial holds several patents on FAAH enzyme inhibitors. The patent discloses limited details about BIA 10—, mainly the screening assay results for each of the several hundred candidate compounds to evaluate the effect on FAAH activity.BIA research studies -
Retrieved 29 January Archived from the original on 12 March Retrieved 10 March Collaborative Chemistry Forum. Retrieved 5 February org; Biomedical Research Forum.
Retrieved 5 January Agence Nationale de Sécurité du Médicament et des Produits de Santé. Le Figaro. Retrieved 23 January Inspection générale des affaires sociales. February The Lancet. Science Media Centre, London. European Medicines Agency. Retrieved 22 January In-Pharma Technologist. Retrieved 15 March The Irish Times.
Retrieved 17 March Science Magazine. Nature News. Royal Statistical Society. Retrieved 28 January Archived from the original on 6 February Retrieved 6 February La Depeche.
January 15, Retrieved January 18, Retrieved January 16, BBC News. L'Edition du Soir Ouest France. Channel 4 News. Le Monde. Le frère de la victime : "Je lui ai dit de ne pas le faire" ". Le Dauphine. Une mort cérébrale, cinq hospitalisés".
Retrieved 24 January The Guardian. ABC, AP. Retrieved 16 January New Scientist. Público Portugal. Bibcode : Natur. Archived from the original on 26 February Retrieved 19 January The Guardian Online. Der Spiegel. February 4, Retrieved February 4, RAPS Regulatory Affairs Professional Society.
Retrieved 19 October European Medicines Agency, London. The Financial Times. US Food and Drug Administration. Probandensicherheit hat bei der Genehmigung klinischer Prüfungen höchste Priorität".
Bundesinstitut für Arzneimittel und Medizinprodukte BfArM. Retrieved 26 January November The New England Journal of Medicine. Archived from the original PDF on 22 January Retrieved 25 January Archived from the original PDF on 5 February Retrieved 27 January Archived from the original on 19 May Que dit la loi?
June ACS Medicinal Chemistry Letters. Archived from the original PDF on 20 October Retrieved 15 January Journal of Analytical Toxicology. October Forensic Science International.
Eddleston M, Cohen AF, Webb DJ April British Journal of Clinical Pharmacology. Hawkes N January Senn S, Amin D, Bailey RA, Bird SM, Bogacka B, Colman P, et al.
Journal of the Royal Statistical Society Series A: Statistics in Society. Expert Group on Phase One Clinical Trials Chairman: Professor Gordon W. Duff 30 November Department of Health, United Kingdom. Archived from the original on 24 February CBC CBCA CBCA-A CBCB CBCBA CBCP CBCPA CBCV CBCVA CBCQ.
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Arachidonoyl ethanolamide AEA; anandamide 2-Arachidonoylglycerol 2-AG 2-Arachidonyl glyceryl ether 2-AGE; noladin ether 2-Oleoylglycerol 2-OG N-Arachidonoyl dopamine NADA N-Arachidonylglycine NAGly 2-Arachidonoyl lysophosphatidylinositol 2-ALPI N-Arachidonoyl serotonin AAHT Docosatetraenoylethanolamide DEA Lysophosphatidylinositol LPI Oleamide Oleoylethanolamide OEA Palmitoylethanolamide PEA RVD-Hpα Stearoylethanolamide SEA O-Arachidonoyl ethanolamine O-AEA; virodhamine.
Cannabicyclohexanol Cannabinor CBD-DMH CP 47, C6 -CP 47, C9 -CP 47, CP 55, CP 55, DeltaCannabidiol Etrinabdione HU HU HU HU HU HU HU HU HUF Nonabine O O O O O O O O SPA Tinabinol. AZ AZD BIM FUBIMINA MCHB-1 PF RQ CP, CP, One possible cause may be the fact that the potential usefulness of BIA is so widespread and involves so many different medical specialties.
Consequently, development of validated applications and the necessary FDA clearances will take time. The purpose of this section of our website is to provide descriptions of current applications of BIA. These descriptions are drawn from a number of sources, but we maintain emphasis on peer-reviewed literature.
Case Studies Several of our customers have been kind enough to write about how BIA affects their work…. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
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Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. gov Identifier: NCT Recruitment Status : Completed First Posted : March 27, Last Update Posted : March 27, View this study on the modernized ClinicalTrials.
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The purpose of this study was to compare the bioavailability and tolerability of BIA under fasted and fed conditions. Detailed Description:. This was a Single-centre, two-way crossover, randomised, open-label study in 12 healthy male volunteers.
Subjects received a single oral mg dose of BIA following a standard meal in one period, and following at least 10 hours of fasting in another period.
Treatment periods were separated by a washout interval of 2 weeks or more. Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Hypertension. FDA Resources. Arms and Interventions.
BIA capsules 50 mg. In one period subjects received 4 capsules of 50 mg of BIA after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA after a standard high-fat and high-calorie meal.
Outcome Measures. Primary Outcome Measures : Cmax - the maximum plasma concentration [ Time Frame: pre-dose and 0. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Layout table for eligibility information Ages Eligible for Study: 18 Years to 45 Years Adult Sexes Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria.
Bioelectrical impedance analysis BIA may rrsearch a more accurate indicator of resewrch since it can distinguish the stuies BIA research studies muscle and Vegan weight loss in children. Portable blood sugar monitor pilot shudies investigated discrepancies Vegan weight loss BMI BIA research studies BIA body Carbohydrate and mood stabilization classifications Hydration for post-workout recovery children with high reserch of physical Vegan weight loss. BIA BBIA were used to collect Studise child's body resesrch percentage and BMI score, researcn those numbers were categorized by BIA and BMI normative values as either underweight, healthy, overweight, or obese. Conclusions: This pilot study demonstrated that there is a significant difference in how BMI and BIA discriminate between the different body composition categories. BIA consistently shows to be a more accurate tool in assessing obesity rates in children since it directly measures body fat. Childhood obesity in the United States has steadily increased over the last 30 years and currently impacts over 13 million children nationwide 1. Research has shown that childhood obesity is an important risk factor for the development of Type 2 diabetes and cardiovascular diseases which can become chronic as body fat BF percentages increase 1.
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