Prostate Cancer - Vitamin E, Soy and Selenium

Source:J Clin Oncol, May 2, 2011. [Epub ahead of print].

Research: High-grade prostatic intraepithelial neoplasia (HGPIN) is a putative precursor of invasive prostate cancer (PCa) and preclinical evidence suggests vitamin E, selenium and soy protein may prevent the progression of HGPIN to PCa. This hypothesis was tested among 300 men in a randomized phase III double-blind study of daily soy (40 grams), vitamin E (800 IUs) and selenium (200 μg) consumption versus placebo. Treatment was administered daily for 3 years. Follow-up prostate biopsies occurred at 6, 12, 24 and 36 months post-randomization.

Results: For all patients, the median age was 63 years. The median baseline prostate-specific antigen (PSA; n = 302) was 5.41 ug/L; total testosterone (n = 291) was 13.4 nmol/L. Invasive PCa developed among 26% of patients. Gleason score distribution was similar in both groups, with 83.5% of cancers graded Gleason sum of 6. Baseline age, weight, PSA and testosterone did not predict for development of PCa. The supplement was well tolerated with flatulence reported more frequently (27% vs. 17%) among men receiving micronutrients. According to researchers, this trial does not support the hypothesis that combination vitamin E, selenium and soy prevents progression from HGPIN to PCa.

Olive Oil and Stroke

Source: Neurology, June 15, 2011;[Epub ahead of print].

Research: Among participants from the Three-City Study with no history of stroke at baseline, researchers examined the association between olive oil consumption (main sample, n=7625) or plasma oleic acid (secondary sample, n=1245) and incidence of stroke (median follow-up 5.25 years), ascertained according to a diagnosis validated by an expert committee.

Results: In the main sample, 148 incident strokes occurred. After adjustment for socio-demographic and dietary variables, physical activity, body mass index, and risk factors for stroke, a lower incidence for stroke with higher olive oil use was observed. Compared to those who never used olive oil, those with intensive use had a 41% lower risk of stroke. In the secondary sample, 27 incident strokes occurred. After full adjustment, higher plasma oleic acid was associated with lower stroke incidence. Compared to those in the first tertile, participants in the third tertile of plasma oleic acid had a 73% reduction of stroke risk.

Herbs & Botanicals Market - Brazil

By Julie Dennis
otanical sales continue their gradual ascent in regions across the globe regardless, or perhaps because of, economic woes.

“Part of it is economics; you can’t afford to get sick,” said George Pontiakos, president and CEO, BI Nutraceuticals, Long Beach, CA. “The trusted, consultative, medical resource is not out there; your family doctor is not there anymore and people are recognizing they have to take their health into their own hands.”

It’s not all economics, though. Many people simply want to live healthier lives and botanicals are simply part of that goal. “Consumers continue to demonstrate their interest in and demand for natural ways to improve their health,” said Mark Blumenthal, founder and executive director, American Botanical Council (ABC), Austin, TX, and editor of HerbalGram and HerbClip.

Increasing demand for botanical remedies is both a national, and international, trend. In fact, the global herbal supplement and remedies market is expected to reach $93 billion by 2015, according to a new report by San Jose, CA-based Global Industry Analysts, Inc.

Brazil: Botanical Climate

Another notable botanical market is Brazil, as regulations continue to change and opportunity continues to knock. The economy is relatively stable, wages are rising for many, and education and consumer demand for dietary supplements are increasing.

“Brazil is going through a period of rapid growth, and consumption of health and beauty products is growing accordingly,” said Paul Altaffer, vice president of business and product development, RFI Ingredients, LLC, Blauvelt, NY. “Supplement sales are soaring as consumers are buying international and domestic branded products. As the economy grows so does income—and Brazil’s income inequality gap is narrowing, meaning more Brazilians can afford what a short period of time ago were considered luxury goods.”

Brazil shares the same health concerns experienced by most industrialized nations, including obesity/overweight, lack of energy, stress, heart issues and immunity, according to Mr. Altaffer.

The aging population in Brazil, similar to the EU and the U.S., is also a driving force behind consumer spending. In fact, consumers over age 60 are estimated to contribute about 13% of Brazil’s total income, according to a Euromonitor report.

Addressing these concerns are some of the top-selling botanicals, including guarana, mate, acerola, acai, camu camu, cha de bugre, catuaba and boldo, Mr. Altaffer said.

But with opportunity also comes challenges, especially as regulations continue to evolve and thwart more dramatic sales increases. One factor contributing to this slowing pace is the group of South American countries currently banding together to develop uniform regulations.

Countries involved in this process include Brazil, Argentina, Paraguay, Chile and Uruguay. Consensus and stability are still elusive as these diverse countries attempt to transform the regulatory landscape.

“The system is quite bureaucratic. It becomes more complex as a result of Brazil’s (primarily) effort to come up with a common regulatory environment (similar to CODEX in Europe),” Mr. Altaffer explained. Needless to say, the pace of adopting new regulations has been slow.

The emerging regulations are intended to bring Brazil “in line with U.S. and European regulatory frameworks. Brazil emulates the Europeans. As a result, supplements must all be registered with ANVISA (Brazil’s regulatory agency for health products and services), demonstrating safety/toxicity, efficacy and so on,” Mr. Altaffer added.

Botanical Drug Update

The botanical drug industry is steadily growing despite high costs of approval.

Over the past decade, a new U.S. botanical drug industry has been steadily growing, according to Freddie Ann Hoffman, MD, CEO and founding member of the Washington, D.C.-based consulting firm HeteroGeneity, LLC, which focuses on the development of complex, heterogeneous products, such as botanicals, for the U.S. market.

Unlike dietary supplements, products classified as botanical drugs are intended for use in the diagnosis, mitigation, treatment, cure or prevention of disease, and also affect the structure or function of the body, Ms. Hoffman explained. In the U.S., these disease claims classify the product as a drug under the federal Food, Drug and Cosmetic Act.

Any product not already approved as a “drug” must be approved under a New Drug Application (NDA) with FDA prior to being marketed.

To study a new drug, the drug’s sponsor must first file an Investigational New Drug (IND) application with the FDA. This allows the drug to be studied in humans to obtain the safety and efficacy data required for U.S. drug approval.

Furthermore, the product must be manufactured under strict conditions with a high-level of reproducibility and documentation, including the collection of nonclinical, and clinical data, using rigorous experimental designs, Ms. Hoffman said.

Regardless of the high cost of pursuing a drug approval, for many manufacturers the appeal outweighs the price. There are approximately “500 INDs for botanical drugs that have been submitted to FDA in various stages of development. Many of these future drugs offer novel mechanisms of action,” Ms. Hoffman noted.

While not a “botanical,” FDA approved a complex natural drug from an omega 3 fatty acid rich fish oil in November 2004. This drug is now marketed as Lovaza (GlaxoSmithKline), and according to IMS Health has had annual sales exceeding $1 billion dollars since 2009.

In October 2006, the green tea extract Veregen was also approved as a “new” drug, and is now a prescription drug approved for topical use to treat genital warts. Further, several older botanical ingredients, such as psyllium, are regulated as both “food” and “drug” ingredients.

The potential benefits for the manufacturer pursuing a drug classification include significantly stronger labeling, such as direct clinical indications and promotional claims, warnings, precautions and contraindications for clinical use, and therefore “buy-in” by U.S. healthcare professionals—with possible reimbursement for prescription drugs. There is also significant protection of proprietary information, including trade secrets—i.e., competitors cannot “borrow” science, unless the second drug is a “generic equivalent.”

“To claim ‘generic equivalency,’ the active(s) from both drugs must be administered to human subjects and demonstrate comparable absorption and distribution patterns, in conformance with standardized ‘bioequivalence’ testing procedures,” Ms. Hoffman explained.

Also, approved NDAs are given a period of exclusive marketing rights wherein FDA is prohibited from accepting another NDA submission for an identical product.

“There are many diseases and conditions that do not respond to a single drug. Cancer is one of these, as is HIV infection and other infectious and inflammatory conditions. The standard of care for these conditions is to use a ‘cocktail’ of drugs,” said Ms. Hoffman. “Because botanicals are such complex products they may be able to hit multiple targets to prevent the resistance formed by malignant cells and some infectious agents, for example.”

“Nature is a fantastic biochemist, which offers infinite possibilities for drug exploration,” she said, adding that if proven to work under strict U.S. drug law, “the future for complex drugs in the U.S. is wide open and bright.” —JD

Inability of Liver to Produce DHA May Contribute to Alzheimer’s

UC Irvine researchers have discovered that markedly depleted amounts of an omega 3 fatty acid in brain tissue samples from Alzheimer’s patients may be due to the liver’s inability to produce the complex fat, also contained in fish-oil supplements.

Low levels of docosahexaenoic acid, or DHA, have been associated with the chronic neurodegenerative disease affecting millions of Americans, but no cause had been identified.

In postmortem liver tissue from Alzheimer’s patients, the UCI team found a defect in the organ’s ability to make DHA from shorter molecules present in leafy plants and other foods. Previous studies have shown that most brain DHA is manufactured in the liver.

Non-Alzheimer’s livers did not have this defect, said Daniele Piomelli, the Louise Turner Arnold Chair in the Neurosciences and director of the Center for Drug Discovery at UCI, who led the research with Giuseppe Astarita, project scientist in pharmacology.

“We all know Alzheimer’s is a brain disease, but our findings—which were totally unexpected—show that a problem with liver fat metabolism can make people more vulnerable,” Piomelli said. “They also suggest a reason why clinical trials in which Alzheimer’s patients are given omega-3 fatty acids to improve cognitive skills have had mixed results.”

The study appears Sept. 8 in the open-access, peer-reviewed journal PLoS ONE.

DHA occurs naturally in cold-water fatty fish and seaweed. It is essential for the proper functioning of adult human brains and for the development of our nervous system and vision during the first six months of life. Omega 3 fatty acids are also part of a healthy diet that helps lower risk of heart disease.

“Additionally, we found that the greater the amount of Alzheimer’s-related cognitive problems experienced in life by the patients, the lower were their liver DHA levels,” Astarita said. “So we do see a connection.”

Piomelli added that the results point to new diagnostic and dietary approaches to Alzheimer’s: Specific blood lipid profile tests might identify at-risk persons, and dietary supplements with a chemically enhanced form of DHA may benefit early-stage patients.

“Our research isn’t advocating that liver metabolism is a key to Alzheimer’s,” he noted. “The factors causing the disease are many and complex, but we feel this is another piece in the Alzheimer’s puzzle.”

O abençoado Alho

O alho (Allium sativum) é um vegetal da família Liliacerae, sendo encontrado na forma de raiz. Seu bulbo, vulgarmente conhecido como cabeça, é constituído por vários dentes, os quais são empregados como condimento culinário e como medicamento há centenas de anos em todo o mundo. Este emprego na culinária o coloca em vantagem frente a outras ervas de efeito farmacológico conhecido e desejável como o Ginkgo biloba, por exemplo.

Antigamente, no Egito, o alho era usado para remediar a diarréia e, na Grécia antiga, ele era empregado como medicamento no tratamento de patologias pulmonares e intestinais. Pesquisas recentes identificaram que o alho possui ainda diversas propriedades dentre as quais se destacam as antimicrobianas, antineoplásicas, terapêuticas contra doenças cardiovasculares, imunoestimulatórias e hipoglicemiante.
Pasteur relatou, em 1858, a atividade antibacteriana do alho que tem sido confirmada por diversos autores até hoje. Em laboratório, mediante diluição em série, o extrato fresco de alho mostrou ser capaz de inibir o crescimento de 14 espécies de bactérias, entre as quais o Stafilococcus aureus, Klebsiella peneumoniae e Escherichia coli, que são bactérias potencialmente maléficas à saúde. Isto ainda se deu, mesmo usando o extrato de alho diluído 128 vezes.

Uma solução de 5% preparada com alho fresco desidratado mostrou atividade bactericida contra Salmonella typhimurium. Isto é atribuído à alicina, o componente chave da atividade antimicrobiana que também é responsável pelo odor característico do alho. A atividade antimicrobiana do alho é reduzida com sua fervura pois a alicina é desnaturada durante o processamento térmico.
O alho ainda tem se mostrado ser capaz de combater o Helicobacter pylory, a maior causa de dispepsia, câncer gástrico e também de úlceras gástricas e duodenais. Foi observado recentemente que 2g/L de extrato de alho inibe completamente o crescimento do H. pylori. Os autores concluíram que este efeito bactericida pode contribuir para prevenir a formação de câncer gástrico.

Esta evidência foi comprovada num estudo epidemiológico efetuado na China, onde foi notado que: O risco de câncer gástrico é 13 vezes menor em indivíduos que consomem 20g/dia de alho em relação aqueles que consomem menos que 1g/dia. Em outro estudo, na Itália, foi observada uma correlação negativa entre o consumo de alho e o risco de câncer gástrico (risco relativo = 0,8). O efeito anticancerígeno do alho parece estar ligado à estimulação da enzima hepática glutationa S-transferase envolvida em processos de detoxicação de muitos carcinógenos.

A seguir, no quadro 1, podemos observar a composição centesimal do alho.
O que mais se destaca na composição nutricional do alho, são os altos teores dos elementos zinco e selênio, ambos metais antioxidantes. No organismo humano, estes nutrientes estão envolvidos tanto direta como indiretamente no funcionamento do sistema imunológico.

Diversos são os estudos que têm identificado baixos níveis sangüíneos tanto de selênio como de zinco, em pacientes portadores de patologias como a AIDS, onde o sistema imunológico encontra-se gravemente debilitado. A prescrição dietoterápica atualmente feita para tais pacientes preconiza o consumo de alho, entre outras coisas. Há estudos que apontam para uma atividade anti-viral do alho. Neste sentido, seu consumo também é indicado para casos de resfriado, gripe e nas viroses em geral.
A propriedade imunoestimulatória do alho está, também, relacionada à presença de substâncias encontradas no seu extrato (dialil trisulfito e dialil sulfito) que estimulam a imudidade de uma maneira geral (estimula a proliferação de células T e de citocinas produzidas por macrófagos). Neste sentido, estudos têm demonstrado que o alho atua estimulando tanto a imunidade humoral como a celular.

Outro efeito nutracêutico notável do alho esta relacionado aos benefícios cardiovasculares que ele proporciona. O consumo regular de alho reduz o nível do colesterol sérico total, evita a agregação plaquetária e também possui atividade antioxidante, prevenindo aterosclerose e doenças cardiovasculares. Estudo canadense efetuado com homens moderadamente hipercolesterolêmicos (32 a 68 anos) mostrou que o consumo de 7,2g/dia de extrato de alho durante meio ano reduz em 5,5% a pressão arterial sistólica, em 7,0% o colesterol sérico total e em 4,6% o colesterol de baixa densidade (LDL).

A atividade hipocolesterolêmica do alho se deve à inibição de diversos passos enzimáticos da síntese hepática do colesterol e a um acréscimo na excreção de ácido biliar e de esteróis. Os componentes do alho alicina, alinina e S-alil sulfato exibem propriedades que inibem a agregação plaquetária. O efeito em rede de tais propriedades resulta na prevenção da aterosclerose e das doenças cardiovasculares.
Na prevenção de doenças, o alho também tem merecido destaque. Recentemente, um estudo epidemiológico efetuado em duas regiões distintas da China, uma que emprega o alho na culinária e outra que não o utiliza, mostrou que a região que usa regularmente o alho tem menores índices de morbidade e de mortalidade em relação a região que não utiliza o alho na alimentação.

Se não bastasse todos os benefícios à saúde aqui descritos, o alho ainda possui propriedades hipoglicemiantes. O extrato de alho mediante seu componente sulfóxido S-alilciteína, reduziu significantemente a glicose sangüínea. O mecanismo provável desta atuação se deve, ao menos em parte, ao estímulo à secreção de insulina pelas células ß do pâncreas.

- Pricipais benefícios do consumo regular de alho na
quantidade mínima de 8g/dia.
Aumenta a longevidade
Reduz os riscos de infarto
Favorece o bom funcionamento do sistema imunológico
Reduz a glicose sanguínea
Reduz o colesterol LDL (ruim)
Aumenta o colesterol HDL (bom)
Combate bactérias e vírus
Previne a aterosclerose
Previne o câncer
Melhora a qualidade de vida

Em resumo, os dados dos estudos apontam para diversos benefícios à saúde derivados do consumo regular do alho. Isto torna o alho uma especiaria extremamente atrativa de ser incluída no cardápio diário não somente pelo seu aroma e sabor, mas também pelos seus benefícios medicinais.

Types of Functional Foods

There are three different types of functional foods. First, there are those products that are inherently healthy. This includes products that do not add any bioactives, but intrinsically contain nutritional compounds that have scientific data to support functionality. For instance, Welch’s grape juice sales increased 33% following the release of clinical data supporting antioxidant activity and cardiovascular benefits; Gardenburger sales increased 25% in the two months following the FDA approved health claim for soy; cranberry juice sales increased 20% after the results of a 1994 Harvard study demonstrated health benefits; and General Mill’s Cheerios sales jumped 11% after being marketed for a heart health benefit.

The second category of functional foods includes those which add a researched bioactive compound to provide a health benefit. The classic example here is Tropicana Pure Premium orange juice, which reformulated its line with added calcium, growing sales 173% and building a new category. This class of functional foods addressed the reintroduction of orphaned phytonutrients.

Finally, engineered functional foods are those formulated specifically to deliver a desired functional benefit. Whether you knock back a Red Bull for an energy lift, a PowerBar for sports performance benefit, or a Gatorade to replenish electrolytes, these products are based on scientific research to deliver to the consumer a desired benefit.

Functional foods are not a panacea and are therefore bound to be abused, just as dietary supplements have been. In other words, in controlled dosing, such as pills, one can specify the amount of certain bioactive compounds such as vitamin A. But when these compounds are in a food product, it is a bit more difficult to manage the dosing, especially when a good tasting snack product is involved. Maybe one just wasn’t enough and soon the consumer is doubling or tripling the amount of vitamin A, possibly reaching a potentially toxic level. Remember General Mill’s Cheerios? Well, FDA recently claimed that Cheerios were being marketed as a drug, since the company promoted cholesterol reduction of 4% in six weeks.

Another valid concern is the encouragement of additional caloric intake. Functional foods “delude people into thinking that [they] are healthy,” says author and New York University food scientist Marion Nestle. And many of the foods marketed as functional are not particularly “healthy” aside from the bioactives involved.

Considering more than half of households are using food or beverages to treat or manage specific health issues, it is important to recognize the burden that must be carried by companies marketing these products. If consumers are eating medicine like it’s food, they could get too much of a good thing. And the consumption of additional calories simply feeds a real health pandemic: obesity. So it is very important that manufacturers think very carefully about what they are formulating and how they are marketing these functional food products. The key take away is this: functional food success will be defined by wellness, not disease treatment.

Women Feel Empowered by Active Lifestyles

A new survey of 443 women ages 25-49 showed those who work out regularly do not just do it to be healthy; they do it to feel like a more confident, energized and accomplished woman. In fact, nearly all active women—more than nine out of 10—say working out regularly makes them feel healthier (100%), stronger (98%) and more energized (94%). These same women report that regular workouts make them feel more confident and accomplished (86%).

The findings are based on a survey sponsored by Propel Enhanced Water and conducted by Opinion Research Corporation (ORC). The survey finds that three out of four say they are always searching for new and easy ways to stay well and feel good.

"Today's woman is busy and juggles multiple priorities. When I learned that so many women are searching for easy ways to stay well and feel good, and that more than 60% of active women said that water alone doesn't cut it when it comes to staying hydrated, I was happy to know that Propel can offer a solution," said Esperanza Teasdale, director of marketing, Propel, PepsiCo.

According to the findings, more than half of active women who work out regularly are more likely to say "yes" to romance, a date or an evening out with friends:

• 51% feel more inclined toward romance

• 37% say they are more likely to want to go out on the town with friends

• 36% report they are more inclined to go out on a date

Women who are not currently active admit that working out at least three days a week would not just make them healthier, but also make them feel sexier and more confident. Nearly all (98%) of non-active women say working out regularly would make them feel healthier, more energized (96%), stronger (92%), more confident (78%) and more accomplished (72%). Additionally, 82% say they would feel more attractive and sexier (68%).

These findings support Propel's latest campaign—Satisfy Your Body with Propel—which represents real women who are energized and empowered by physical activity and understand the need to replenish, energize and protect in all aspects of their lives.