Prostate Support with neoProstate b-300 -- Research

For years Europeans have been importing most of the saw palmetto berries harvested in Florida, extracting the fatty acid solids and refining it to a standardized extract. This extract is sold by prescription for use with prostate and urinary problems under the names Talso, Prostagutt and Permixon in France and Germany. In Italy, 49% of the benign prostatic hyperplasia (BPH) products are reported to be saw palmetto extracts. In addition, pygeum bark, pumpkin seed and stinging nettle root products, or combinations of these with saw palmetto are used, and in all, approximately 90% of BPH product sales in Europe are herbal preparations.

Prostate Nutrition: The one common denominator to all the herbal products mentioned above is their phytosterol content, namely beta-sitosterol. Since saw palmetto is the most available of these herbs, it forms the basis for most preparations, however, consistency and quality are becoming significant problems as the demand for saw palmetto has been quickly escalating. The saw palmetto berries are sometimes being picked and sold green, before the traditional buying period, with unknown effects on the quality and constituents. Because of this, Beachwood Canyon, Naturally, Ltd. decided to bypass the quality control issues of saw palmetto and introduce neoProstate, a product that is made up of the "common denominator," with added zinc. Zinc is an important mineral for a healthy prostate, and is found in high concentration in the prostate (marginal zinc deficiency is very common among older men in the United States). The product is intended to be taken with a quality multi-vitamin-mineral supplement supplying at least 100 i.u of natural vitamin E, and 100 to 200 mcg. of selenium, 400+ i.u. vitamin D, and bio-functional calcium - important nutrition for good prostate health. (We elected not to include these in neoProstate since it is too easy to take too much selenium, for example, from multiple products containing it. Ultra-Freeda multi-supplement provides an excellent source of the vitamins and minerals you need at every meal, along with neoProstate.)

In a normal diet, beta-sitosterol is the main dietary phytosterol complex. It is abundant in avocado, peanuts, sunflower seeds, soy beans, corn and most vegetables. As such, neoProstate b-400 is a natural, food-derived supplement.

The problem today is, you simply can't get adequate amounts of beta-sitosterol from foods in a typical western diet. (If you lived in Japan, where prostate problems in men under 65 are rare, prostate and breast cancer occurs later in life and has a lower mortality, you would still obtain over 300 mg from diet.) Western growing techniques have systematically removed fatty acids, part of which are the phytosterols, from the food supply. While this reduces food loss from rotting, it also alters the nutritional composition of your food. Today, the average American diet provides much less than the optimal 300 mg. of beta-sitosterol complex. Actually about 50 to 80 mg per day (Awad & Fink, J of Nutrition, 2000 Sep;130(9):2127-30). In addition, as you age, the ability for your digestive system to extract adequate beta-sitosterol from your food and assimilate it, reduces. So when you need it most (after the midlife changes) you are receiving less and not processing it as well.

In foods, the typical composition of beta-sitosterol complex is at least 40 percent beta-sitosterol, 23 to 28% campesterol, 12 to 18% stigmasterol, with the balance being made up of several other lesser sterols. This complex is commonly referred to as beta-sitosterol complex. In neoProstate, the typical composition is 50% beta-sitosterol, plus at least 2-to-2.5% beta sitostanol content. (Phytostanols are saturated phytosterols and are easily damaged. Their presence in neoProstate is a reflection of the higher quality ingredients found in our products.)

How beta-sitosterol works -- the science:

Prostate Specific: In the human body, supplemental beta-sitosterol acts in several ways. First, it protects the prostate against growth caused by age-related reactivation of increased conversion of testosterone to the dihydrotestosterone (DHT) form, and decreases serum estrogen(2) levels. The higher production of DHT is normal from puberty to the early 20s, a man's most sexually active period. In an adult, however, reactivated production of DHT is a major contributing factor in undesirable growth of the prostate, or benign prostatic hyperplasia (BPH). By normalizing this conversion and depriving the prostate of the active metabolite DHT, prostatic tissue growth ceases and existing tissue atrophies. (Kirby RS, Christmas TJ. Benign Prostate Hyperplasia. London, England: Mosby-Year Book Europe Limited; 1993) Beta-sitosterol has been shown to do just this, naturally block this unwanted conversion, reducing and normalizing the supply of DHT to the prostate, and, in effect, maintain a normal male hormone balance for a healthy prostate. (Shrinkage in volume of the prostate from either beta-sitosterol or use of the herbal products appears to be a mixed clinical picture. Some reports indicate significant symptom improvement with no change in volume, while others report shrinkage. Since beta-sitosterol does not appear to affect prostate cell apoptosis of the cells stimulated by DHT [unlike cancer cells], the existing cells, and consequent volume increase will only reduce upon their death after their extended life span. The differences in reports may be due to the end period of the research protocols, since it seems that this could take as long as 18 months, long past the end point of most research. Also, beta-sitosterol has no demonstrated effect on inflammation of the prostate, which could account for some of the reported volume increase. For inflammation related products, see BCN's Epilobium and CM+ Cetyl Myristoleate.)

Effects on Prostate and other Cancer Cells: A second action specific to the prostate was shown for beta-sitosterol by Zahradnit, et al, in Fortschritte Med., vol. 98, p. 69-72 (1980). Here it was shown that beta-sitosterol inhibited the development of prostate adenoma (tumor) and depressed prostaglandins that are known to support tumor growth. A similar action has been demonstrated in mice for colon cancer, with beta-sitosterol inhibiting the growth of malignant tumors from chemically-induced colon cancer. In a more recent study, beta-sitosterol was shown to inhibit HT-29 human colon cancer cell growth. (The clinical implications of this are yet to be researched.)

In Vitro & In Vivo Effects on Prostate Cancer Cells:

Title: In vitro and in vivo (SCID mice) effects of phytosterols on the growth and dissemination of human prostate cancer PC-3 cells.
Author: Awad AB; Fink CS; Williams H; Kim U
Address: Department of Physical Therapy, Exercise and Nutrition Sciences, State University of New York at Buffalo, 14214, USA..
Source: Eur J Cancer Prev 2001 Dec;10(6):507-13 (ISSN: 0959-8278)

The dietary effect of phytosterols (PS) versus cholesterol on the growth and metastasis of the PC-3 human prostate cancer cells in SCID mice was studied. Also, their direct effect on the growth and migration of these cells in vitro was analysed. In the in vivo experiment, SCID mice were fed a diet containing 2% of either PS mixture or cholesterol plus 0.2% cholic acid and implanted with 2 x 10(6) tumour cells per mouse. Tumour growth was monitored for 8 weeks post inoculation. Animals fed the PS diet had tumours 40-43% smaller than those fed the cholesterol diet. Furthermore, the number of mice with lymph node and lung metastasis was almost one-half that of the cholesterol-fed group. In the in vitro studies, both beta-sitosterol and campesterol inhibited the growth of PC-3 cells by 70% and 14%, respectively, while cholesterol supplementation increased the growth by 18% when compared with controls. PS inhibited the invasion of PC-3 cells into Matrigel-coated membranes by 78% while cholesterol increased it by 43% as compared with the cells in the control media. Migration of tumour cells through 8 microm pore membranes was reduced by 60-93% when the PC-3 cells were in PS media, as compared with a 67% increase after cholesterol supplementation. PS supplementation reduced the binding of PC-3 cells to laminin by 15-38% and fibronectin by 23% while cholesterol increased binding to type IV collagen by 36%. It was concluded that PS indirectly (in vivo as a dietary supplement) and directly (in tissue culture media) inhibited the growth and metastasis of PC-3 cells. beta-Sitosterol was more effective than campesterol in offering this protection in most of the parameters studied.

The following article is suggestive of one of the possible mechanisms of beta-sitosterol:

Title: beta-Sitosterol activates the sphingomyelin cycle and induces apoptosis in LNCaP human prostate cancer cells.
Author: von Holtz RL; Fink CS; Awad AB
Address: Department of Physical Therapy, Exercise, and Nutrition Sciences, State University of New York at Buffalo 14214-3000, USA
Source: Nutr Cancer, 32(1):8-12 1998

Epidemiological evidence has shown that men consuming a low-fat, high-fiber diet containing high amounts of plant products have a lower risk of prostate cancer than men consuming a Western diet. One of the main differences between these two diets is the type of dietary fat, including dietary sterols. This study was undertaken to compare the effect of two dietary sterols on prostate cancer cells in vitro. Beta-Sitosterol (SIT), the most common plant sterol, and cholesterol, an animal sterol, were compared for effect on LNCaP cell growth, differentiation, apoptosis, and sphingomyelin cycle intermediates. Cells were treated for up to seven days with sterols delivered by a cyclodextrin vehicle. Compared with cholesterol, SIT (16 microM) decreased growth by 24% and induced apoptosis fourfold, which was accompanied by cell rounding and a 50% increase in ceramide production. No effect was observed on differentiation as measured by prostate-specific antigen and prostatic acid phosphatase, although total acid phosphatase increased with SIT treatment for up to seven days. The results suggest that the decrease in cell number and increase in apoptosis associated with SIT treatment are mediated by activating the sphingomyelin cycle.

Effects in Human Studies for BPH:

Two studies have shown beta-sitosterol to be "an effective option in the treatment of BPH." The abstracts from these two articles are reprinted here for your review:

Title: Randomized, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group.
Author: Berges RR; Windeler J; Trampisch HJ; Senge T
Address: Department of Urology, Ruhr-University, Bochum, Germany.
Source: Lancet, 345(8964):1529-32 1995 Jun 17

Abstract: Medical treatments have become available for benign hypertrophy of the prostate, including alpha-receptor blocking agents and 5-alpha-reductase inhibitors. Drugs derived from plants, for which no precise mechanism of action has been described, are widely used for this purpose in Europe. In a randomized, double-blind, placebo-controlled multicentre study, 200 patients (recruited between April and October 1993) with symptomatic benign prostatic hyperplasia were treated with either 20 mg beta-sitosterol (which contains a mixture of phytosterols) three times per day or placebo. Primary end-point was a difference of modified Boyarsky score between treatment groups after 6 months; secondary end-points were changes in International Prostate Symptom Score (IPSS), urine flow, and prostate volume. Modified Boyarsky score decreased significantly with a mean of -6.7 (SD 4.0) points in the beta-sitosterol-treated group versus -2.1 (3.2) points in the placebo group p < 0.01. There was a decrease in IPSS (-7.4 [3.8] points in the beta-sitosterol-treated group vs -2.1 [3.8] points in the placebo group) and changes in urine flow parameters: beta-sitosterol treatment resulted in increasing peak flow (15.2 [5.7] mL/s from 9.9 [2.5] mL/s), and decrease of mean residual urinary volume (30.4 [39.9] mL from 65.8 [20.8] mL). These parameters did not change in the placebo group (p < 0.01). No
relevant reduction of prostatic volume was observed in either group. Significant improvement in symptoms and urinary flow parameters show the effectiveness of beta-sitosterol in the treatment of benign prostatic hyperplasia.

Title: A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group.
Author: Klippel KF; Hiltl DM; Schipp B
Address: Department of Urology, Allgemeines Krankenhaus Celle, Academic Hospital, Germany.
Source: Br J Urol, 80(3):427-32 1997 Sep

Abstract: OBJECTIVE: To report the results of a double-blind, placebo-controlled trial to evaluate Azuprostat, a beta-sitosterol, in patients with symptoms of outlet obstruction caused by benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: A randomized, double-blind and placebo-controlled clinical trial was conducted to assess the efficacy and safety of 130 mg free beta-sitosterol (phytosterol) daily, using the international prostate symptom score (IPSS) as the primary outcome variable. In total, 177 patients with BPH were recruited for 6 months of treatment in 13 study centres. In addition to the relative difference in the IPSS, changes in quality of life, peak urinary flow rate (Qmax) and post-void residual urinary volume (PVR) were recorded. The drug used in the trial consisted of a chemically defined extract of phytosterols, derived for example from species of Pinus, Picea or Hypoxis, with beta-sitosterol as the main component. RESULTS: There were significant (P < 0.01) improvements over placebo in those treated with beta-sitosterol; the mean difference in the IPSS between placebo and beta-sitosterol, adjusted for the initial values, was 5.4 and in the quality-of-life index was 0.9. There were also significant improvements in the secondary outcome variables, with an increase in Qmax (4.5 mL/s) and decrease in PVR (33.5 mL) in favour of beta-sitosterol when adjusted for the changes after placebo. CONCLUSION: These results show that beta-sitosterol is an effective option in the treatment of BPH.

Effects on Cholesterol:

For over 30 years, research has been conducted on the use of beta-sitosterol and its effects on both cholesterol and triglyceride levels. Dietary supplementation has been shown to effect both the absorption of dietary cholesterol, and the systemic levels of cholesterol and triglycerides, helping to normalize both. Beta-sitosterol is known to interfere with the absorption of cholesterol, possibly because of its competition for the enzyme cholesterol esterase. Systemically, 300 mg per day of beta-sitosterol has been shown to lower blood serum cholesterol and triglyceride levels, if the levels are above normal. It can also improve the HDL / LDL ratio.

Other relevant effects:
Beta-sitosterol has been shown to have anti-inflammatory and antipyretic properties.

Safety:
There are no known safety issues or side effects with the use of beta-sitosterol. There are no known interactions with prescription drugs or any known drug interactions with current conventional cancer therapies.

It is commonly recommended that zinc intake should not exceed 50 mg. per day without supervision of a qualified health professional, for any extended length of time.

neoProstate b-400

$25.95

The above statements are for educational purposes only. These statements reflect only a part of the literature on beta-sitosterol and do not constitute a thorough or exhaustive review. This information has also been limited to issues relevant to the use of beta-sitosterol as a dietary supplement and its role in the health of the prostate.
The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

neoProstate b-400

$25.95