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Testosterone Replacement, Low T, HCG, & Beyond
Prostate Related Issues
efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating BPH and androgen deficiency
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<blockquote data-quote="madman" data-source="post: 181470" data-attributes="member: 13851"><p><strong>Study design </strong></p><p></p><p><em><span style="color: rgb(184, 49, 47)">This study was conducted in compliance with ICH-GCP (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use –Good Clinical Practice) guidelines and Helsinki Declaration Standards. This clinical study adheres to the CONSORT guidelines.</span></em> The study was performed at Aman Hospital and Research Center, Vadodara, India. <em><span style="color: rgb(184, 49, 47)">The trial was designed as a double-blind, placebo-controlled, single centered study including 99 male subjects randomized to three treatment arms: VISPO, SPO, and placebo, on 1:1:1 ratio (n = 33 in each group). Block randomization was implemented for groupwise allocation of subjects wherein the participants received an xx-digit randomization number. The investigator and subjects were blinded of the interventions. The study medications were dispensed by the unblinded pharmacist at the site. </span></em></p><p></p><p></p><p></p><p></p><p><strong>Background </strong></p><p></p><p>Growing interest in the use of functional foods and dietary supplements for healthcare management has led to the availability of natural products in the market. However, development of nutraceuticals requires supportive evidence of efficacy and tolerability that must be clearly demonstrated with clinical trials [1]. <em><span style="color: rgb(184, 49, 47)">Serenoa repens (saw palmetto) is one of the most studied plants for the treatment of lower urinary tract diseases (LUTS), especially mild to moderate prostatic diseases. Major bioactive principles attributing to the medicinal use of saw palmetto oil are the phytosterols and fatty acids. <strong>Explored mechanisms of action for saw palmetto oil includes inhibition of 5α-reductase, cyclooxygenase (COX) and 5-lipoxygenase (LOX). In addition, it exhibits antiproliferative effect on prostatic epithelial cells and antiestrogenic activity [2].</strong></span></em> Thus, the candidature of saw palmetto preparations as alternative medicine to treat benign prostate hyperplasia has been the subject of clinical research.</p><p></p><p></p><p>Phytoconstituents such as sterols, fatty acids and vitamin E together contribute to the efficacy of SP extract in mitigating the BPH complications [9, 10].<span style="color: rgb(44, 130, 201)"> <em><strong>Conventionally SP oil contains 0.2–0.3% β-sitosterol in addition to fatty acids.</strong></em></span> <span style="color: rgb(184, 49, 47)"><em><strong>Here we have used a 3% β-sitosterol containing SP oil for the clinical evaluation of therapeutic potential, alongside comparing with the conventional SP oil in a placebo-controlled trial. </strong></em></span>Previously we have demonstrated the improved efficacy of β-sitosterol enriched SP oil as compared to the conventional oil in testosterone-induced BPH model rats [11]. <em><strong><span style="color: rgb(184, 49, 47)">Here we have provided the first ever clinical evidence on the improved efficacy of β-sitosterol-enriched SP extract superior to the conventional SP. </span></strong></em></p><p></p><p></p><p><strong>Methods </strong></p><p><strong></strong></p><p><strong>Investigational product </strong></p><p><em><span style="color: rgb(184, 49, 47)"><strong>The investigational product was a standardized saw palmetto extract containing 3% β-sitosterol (VISPO™).</strong></span></em> VISPO and the conventional saw palmetto oil (SPO, 0.2% β-sitosterol) were prepared in-house from the berries (Florida, USA) using the supercritical fluid extraction method. The higher percentage of β-sitosterol in VISPO was achieved by column chromatography. The βsitosterol content was quantified using LCMS analysis (Fig. 1). <em><strong><span style="color: rgb(184, 49, 47)"><u>The extracts were then formulated into powder form </u>with maltodextrin as excipient and filled in capsules (500 mg in weight). <u>Each capsule contained 200 mg of extract</u>.</span></strong></em> Placebo capsules consisted of maltodextrin only.</p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p>The product used in the study contains <span style="color: rgb(184, 49, 47)">(standardized saw palmetto extract containing <strong>3% β-sitosterol </strong>(VISPO™) </span> that was formulated into a powder.</p><p></p><p>Most supplements on the market use <span style="color: rgb(184, 49, 47)">conventional saw palmetto oil <strong>(SPO, 0.2% β-sitosterol)</strong></span> and the capsules are filled with extracts in powder form with added fillers or extracts in powder form mixed with food-grade oils such as pumpkin seed.</p><p></p><p>VISPO™ is the only product on the market which contains 3% β-sitosterol.</p></blockquote><p></p>
[QUOTE="madman, post: 181470, member: 13851"] [B]Study design [/B] [I][COLOR=rgb(184, 49, 47)]This study was conducted in compliance with ICH-GCP (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use –Good Clinical Practice) guidelines and Helsinki Declaration Standards. This clinical study adheres to the CONSORT guidelines.[/COLOR][/I] The study was performed at Aman Hospital and Research Center, Vadodara, India. [I][COLOR=rgb(184, 49, 47)]The trial was designed as a double-blind, placebo-controlled, single centered study including 99 male subjects randomized to three treatment arms: VISPO, SPO, and placebo, on 1:1:1 ratio (n = 33 in each group). Block randomization was implemented for groupwise allocation of subjects wherein the participants received an xx-digit randomization number. The investigator and subjects were blinded of the interventions. The study medications were dispensed by the unblinded pharmacist at the site. [/COLOR][/I] [B]Background [/B] Growing interest in the use of functional foods and dietary supplements for healthcare management has led to the availability of natural products in the market. However, development of nutraceuticals requires supportive evidence of efficacy and tolerability that must be clearly demonstrated with clinical trials [1]. [I][COLOR=rgb(184, 49, 47)]Serenoa repens (saw palmetto) is one of the most studied plants for the treatment of lower urinary tract diseases (LUTS), especially mild to moderate prostatic diseases. Major bioactive principles attributing to the medicinal use of saw palmetto oil are the phytosterols and fatty acids. [B]Explored mechanisms of action for saw palmetto oil includes inhibition of 5α-reductase, cyclooxygenase (COX) and 5-lipoxygenase (LOX). In addition, it exhibits antiproliferative effect on prostatic epithelial cells and antiestrogenic activity [2].[/B][/COLOR][/I][COLOR=rgb(184, 49, 47)] [/COLOR]Thus, the candidature of saw palmetto preparations as alternative medicine to treat benign prostate hyperplasia has been the subject of clinical research. Phytoconstituents such as sterols, fatty acids and vitamin E together contribute to the efficacy of SP extract in mitigating the BPH complications [9, 10].[COLOR=rgb(44, 130, 201)][B] [/B][I][B]Conventionally SP oil contains 0.2–0.3% β-sitosterol in addition to fatty acids.[/B][/I][/COLOR] [COLOR=rgb(184, 49, 47)][I][B]Here we have used a 3% β-sitosterol containing SP oil for the clinical evaluation of therapeutic potential, alongside comparing with the conventional SP oil in a placebo-controlled trial. [/B][/I][/COLOR]Previously we have demonstrated the improved efficacy of β-sitosterol enriched SP oil as compared to the conventional oil in testosterone-induced BPH model rats [11]. [I][B][COLOR=rgb(184, 49, 47)]Here we have provided the first ever clinical evidence on the improved efficacy of β-sitosterol-enriched SP extract superior to the conventional SP. [/COLOR][/B][/I] [B]Methods Investigational product [/B] [I][COLOR=rgb(184, 49, 47)][B]The investigational product was a standardized saw palmetto extract containing 3% β-sitosterol (VISPO™).[/B][/COLOR][/I] VISPO and the conventional saw palmetto oil (SPO, 0.2% β-sitosterol) were prepared in-house from the berries (Florida, USA) using the supercritical fluid extraction method. The higher percentage of β-sitosterol in VISPO was achieved by column chromatography. The βsitosterol content was quantified using LCMS analysis (Fig. 1). [I][B][COLOR=rgb(184, 49, 47)][U]The extracts were then formulated into powder form [/U]with maltodextrin as excipient and filled in capsules (500 mg in weight). [U]Each capsule contained 200 mg of extract[/U].[/COLOR][/B][/I] Placebo capsules consisted of maltodextrin only. The product used in the study contains [COLOR=rgb(184, 49, 47)](standardized saw palmetto extract containing [B]3% β-sitosterol [/B](VISPO™) [/COLOR] that was formulated into a powder. Most supplements on the market use [COLOR=rgb(184, 49, 47)]conventional saw palmetto oil [B](SPO, 0.2% β-sitosterol)[/B][/COLOR] and the capsules are filled with extracts in powder form with added fillers or extracts in powder form mixed with food-grade oils such as pumpkin seed. VISPO™ is the only product on the market which contains 3% β-sitosterol. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Prostate Related Issues
efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating BPH and androgen deficiency
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