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A Review of the Human Clinical Studies Involving Citrus aurantium (Bitter Orange) Extract and its Primary Protoalkaloid p- Synephrine Int J Med Sci. Preuss. 2 , Mohd Shara. Dean Emeritus, Creighton University Medical Center, Omaha, NE 6. USA; 2. Departments of Biochemistry, Medicine and Pathology, Georgetown University Medical Center, Washington, DC 2. USA; 3. Faculty of Pharmacy, Jordan University of Science and Technology, Irbid 2. Jordan. How. to cite this article. Stohs SJ, Preuss HG, Shara M. Everyone knows you can't build muscle and lose fat at the same time, right? Learn how to maximize carbohydrate intake so you have a chance at adding mass while leaning out. Chitosan Reviews - Do Chitosan Products Work? Chitosan comes from the shell of crustaceans. There are many different chitosan supplements or products containing chitosan as an ingredient on the market, and. Be the first to receive exciting news, features, and special offers from Bodybuilding.com! A professional strength anabolic complex that maximizes testosterone and nitric oxide levels to boost muscle, strength, mass, and density. Super Test is the finest testosterone on the market. Thermogenic Fat Burners for some people are a necessity. People who live busy lives, sometimes can not always make to the gym, so that is when thermogenic fat burners can make a difference. Whether you need that extra energy. Integratori alimentari palestraIl tema degli integratori Home > Top 50 Sellers > Megadrine RFA-1(Compare to Xenadrine RFA-1) 120ct Fat Loss Home > Categories > Top 50 Sellers > Megadrine RFA-1(Compare to Xenadrine RFA-1) 120ct Fat Loss Home > Shop by Interest > Buy Ephedra.A Review of the Human Clinical Studies Involving Citrus aurantium (Bitter Orange) Extract and its Primary Protoalkaloid p- Synephrine. Int J Med Sci 2. 01. Available from. http: //www. Abstract. This review summarizes the published as well as unpublished human studies involving Citrus aurantium (bitter orange) extract and its primary protoalkaloid p- synephrine, providing information and an assessment of the safety and efficacy of these widely used products. The results of over 2. Over 5. 0 % of the subjects involved in these studies were overweight/obese, and approximately two- thirds of these overweight/obese subjects consumed caffeine (1. Bitter orange/p- synephrine containing products were consumed for up to 1. Approximately 4. 4 % of the subjects consumed a bitter orange/p- synephrine only product, while the remainder consumed a complex product that contained multiple ingredients in addition to p- synephrine. In general, bitter orange extract alone (p- synephrine) or in combination with other herbal ingredients did not produce significant adverse events as an increase in heart rate or blood pressure, or alter electrocardiographic data, serum chemistry, blood cell counts or urinalysis. Longer term studies are needed to further assess the efficacy of these products and affirm their safety under these conditions. Keywords: Citrus aurantium, bitter orange, p- synephrine, human subjects, obesity/overweight, safety, efficacy, caffeine. Introduction. Citrus aurantium extract and its primary protoalkaloidal constituent p- synephrine (Figure 1) are extensively used in weight management products and as thermogenic agents. They are also used in sports performance products to enhance stamina. It is also known as “Chih- shi” or “Zhi shi” in traditional Chinese medicine . Bitter orange extract is used in weight management products due to its purported effects on metabolic processes, including an increase in basal metabolic rate and lipolysis as well as mild appetite suppression . In general, both the lay public and scientific communities have failed to differentiate between p- synephrine which is a phenylethylamine derivative that has the hydroxy group in the para position on the benzene ring and the synthetic m- synephrine (phenylephrine) which has a hydroxyl group in the meta position on the benzene ring) (Figure 2). Properties possessed by m- synephrine are inappropriately attributed to bitter orange extract and p- synephrine, and clinical case study reports and reviews involving bitter orange extract frequently make inappropriate references to m- synpephrine (see for example . The issue of safety and efficacy is further clouded and complicated by the structural similarity of p- synephrine to ephedrine (Figure 3) and other biogenic amines, in spite of the fact that the pharmacokinetics of the these compounds and their receptor binding specificities are vastly different due to significant structural and stereochemical differences . As a consequence, markedly different pharmacological properties should be anticipated. Other issues have also obfuscated the picture with respect to the safety and efficacy of bitter orange extract. Some of the extracts that are used are either non- standardized or poorly standardized, making it difficult if not impossible to establish reproducibility. In some cases, lack of knowledge of the chemical composition of the extracts being used precludes useful comparisons. Products containing bitter orange extract in most cases contain a variety of other herbal extracts, many of which are caffeine containing. A final issue that has added to the overall confusion regarding bitter orange has been the release of erroneous adverse events information by governmental agencies. Statements implying that large numbers of adverse events and even deaths due to the use of products containing bitter orange extract have clearly been shown to be incorrect and misleading . This review addresses data associated with published human studies, clinical case reports, and unpublished clinical studies. Several recent studies have been conducted with p- synephrine/bitter orange extract alone and will be reviewed. Information with respect to unpublished studies is derived from final research reports available on the internet, presentations at national meetings of professional organizations, and presentations and research reports from the investigators directly involved. References are cited based on the origin of the information. Fig 1. Chemical structure of p- synephrine. The majority of studies have been conducted using products that contain not only an extract of C. The incorporation of bitter orange extract into products containing other potentially active ingredients makes comparative analyses difficult. However, several human safety and efficacy studies have been conducted on bitter orange extract (p- synephrine) alone. The 1. 6 studies published in refereed journals involving bitter orange extract/p- synephrine are reviewed in chronological sequence, and are summarized in Table 1, while 7 studies unpublished to date are summarized in Table 2. Colker et al. The product which was consumed on a daily basis contained 9. C. The total daily intake of phenylethylamine- related protoalkaloids was approximately 5. All subjects in the study followed an 1. American Heart Association Step One diet, and performed a circuit training exercise program three days per week. Table 1. Summary of published human studies involving bitter orange extract and p- synephrine. Product. Treated Subjectsoverwt/ obese. Durationp- Synephrine dose (mg)Caffeine dose (mg)End Point. Adverse events. Reference. Complex. 99. 42 days. Wt. Table 2. Summary of unpublished human studies involving bitter orange extract and p- synephrine. Product. Treated subjectsoverwt/ obese. Durationp- Synephrine dose (mg)Caffeine dose (mg)End Point. Adverse events. Reference. Complex. 22. 22. 70 days. Wt. No significant changes in blood pressure, heart rate, electrocardiographic findings, serum chemistry or urinalysis were noted and no significant changes were observed in the results of the Profile of Mood States Questionnaire for fatigue or vigor. The treated group also experienced a significant increase in basal metabolic rate as compared to the placebo group. The amount of caffeine consumed daily in the product (5. It is not clear whether the weight loss and increase in basal metabolic rate were due to the caffeine, the bitter orange extract, exercise, caloric restriction or a combination thereof. This combination of ingredients and protocol appeared to be effective and safe for promoting modest fat and body weight loss in healthy, overweight adults, although the number of subjects in the study was small . The final report of the study is available on line. One product contained 1. Citrimax. TM), 1. Advantra Z. Thirty- two overweight subjects were divided into three groups and either given the two products (one capsule of each in conjunction with each meal), a diet and exercise program, or the products in conjunction with the diet and exercise program. At the end of the study no adverse side effects were observed or reported. The group consuming the product- only lost an average of 4. In summary, consumption of the products alone was more effective than diet and exercise, while consuming the products in combination with diet and exercise was most effective. No adverse effects were reported. This study was not published and subjected to peer review. Possible cardiovascular effects of Seville (sour) orange juice in normotensive adults were assessed by Penzak et al. The synephrine concentration in the orange juice was approximately 5. Twelve subjects consumed 8 ounces of orange juice (approximately 1. Hemodynamic parameters including heart rate and blood pressure did not significantly differ between control and treated groups. In spite of the lack of evidence, the authors concluded that individuals with tachyarrhythmias, severe hypertension and narrow angle glaucoma as well as monoamine oxidase inhibitor receptors should avoid Seville orange juice. The warning was based on the erroneous assumption that the form of synephrine present in the orange juice was m- synephrine . The product contained a proprietary blend of extracts from C. The product contained 6 mg p- synephrine, 1. The results of these studies were presented at various scientific meetings, but were never published in a scientific journal and subjected to peer review. In each of these studies it is not possible to determine the role of p- synephrine in the observed effects. A double blind cross- over study involving 6 healthy human subjects who received two capsules of Xenadrine EFX. A significant increase (2. No effects on heart rate or blood pressure were observed, and no subjective complaints or adverse events were reported. Kalman et al. Basal metabolic rates were determined at baseline, four hours after a standardized meal at which time two capsules of Xenadrine EFX. At the two and three hour time points after ingestion of the product relative to the control, 1. No significant differences in heart rate or blood pressure were observed in response to the product relative to baseline and control values. Kalman et al. Two capsules of the product were consumed twice daily, containing a total of 2. Nu. Phedrine combines three of the leading and most potent weight loss ingredients to address dieters. Those ingredients are Real South African Hoodia Gordonii in a 2. Slimaluma and Advantra Z in a 3. Bitter Orange has shown amazing results as a thermogenic, since it contains Synephrine, an alkaloid of the Ephedra family, without the dangerous side effects. It will not increase heart rate, and it has no negative effect on the central nervous system. The makers of Nu. Phedrine use only the 3. X strength form of Advantra Z, which is the . The active substance in Hoodia is P5. Clinical trials point to Hoodia. In fact, the Hoodia used in Nu. Phedrine went through its own clinical study, which showed that the average weight loss was 1. Nu. 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