FDA: Stem cell trial can proceed

WASHINGTON (UPI) — The Food and Drug Administration has given approval to proceed with the world’s first human clinical trial of a human embryonic stem cell-based therapy.

Geron Corp., headquartered in Menlo Park, Calif., says it will proceed with its trial of GRNOPC1, a stem-cell therapy intended to treat patients with acute spinal cord injury, a company release said Friday.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” Geron President and Chief Executive Officer Thomas B. Okarma said. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged — to achieve restoration of spinal cord function by the injection of … progenitor (stem) cells directly into the lesion site of the patient’s injured spinal cord.”

“The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury,” said Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. “If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year.”

Copyright 2010 by United Press International

Sourced & published by Henry Sapiechas

Snake Venom Studies Yield Insights

for Development of Therapies

for Heart Disease and Cancer

Science(July 30, 2010) — Researchers seeking to learn more about stroke by studying how the body responds to toxins in snake venom are releasing new findings that they hope will aid in the development of therapies for heart disease and, surprisingly, cancer.

The Japanese team is reporting in a Journal of Biological Chemistry “Paper of the Week” that they are optimistic that inhibiting a protein found on the surface of blood cells known as platelets may combat both irregular blood clotting and the spread of certain cancers throughout the body.

“The finding that platelets not only play a role in blood clotting but also in the development of vessels that allow tumors to flourish was quite unexpected and paves the way for new research on the role or roles of platelets,” says Katsue Suzuki-Inoue, the associate professor at the University of Yamanashi who oversaw the 13-person team’s work in professor Yukio Ozaki’s laboratory.

About platelets, blood clots and stroke

Under normal conditions, platelets are activated to become sticky when blood vessels are injured, and their clumping together (aggregation or clotting) naturally stops bleeding. But, irregular platelet aggregation caused by disease can lead to dangerous clots or even stroke if a clot clogs or bursts in a vessel that carries oxygen and nutrients to the brain.

“When a blood clot, or thrombus, forms during the body’s normal repair process, it’s doing its job,” says Suzuki-Inoue. “But, thrombotic diseases, such as heart attack and stroke, are leading causes of death in developed countries. Understanding and manipulating the underlying chemical reactions could help us save many lives.”

But what does this have to do with snake venom? It’s sort of a long story.

How venom can prevent or cause clotting

“Snake venom contains a vast number of toxins that target proteins in platelets,” says Yonchol Shin, an associate professor at Kogakuin University who specializes in snake toxins. “Some of those toxins prevent platelets from clotting, which can lead to profuse bleeding in snake bite victims. Others, like the one we’ve focused this research on, potently activate platelets, which results in blood clots. Identification of the molecular targets of many of these toxins has made an enormous contribution to our understanding of platelet activation and related diseases.”

Intrigued by the then-recent discovery that elements in snake venom can promote irregular aggregation of platelets — the kind that leads to clots and stroke — Inoue’s and Ozaki’s team set out in 1997 to understand better the molecular underpinnings of those chemical reactions. They hoped that whatever they learned could be applied to the search for new therapies for irregular blood clotting caused by disease.

In 2000, another set of investigators came across a protein on the surface of platelets and dubbed it C-type lectin-like receptor 2, or CLEC-2. At the time, it remained unclear how CLEC-2 was produced or what its job was, but the team suspected it was worth further study.

After six years of research and collaborations with British investigators, the team in 2006 discovered how rhodocytin — a molecule purified from the venom of the Southeast Asia pit viper Calloselasma rhodastoma — binds to the CLEC-2 receptor protein on the platelet surface, spurring the platelet to clot with others like it.

Then, in another JBC “Paper of the Week” in 2007, Suzuki-Inoue and her colleagues reported how a separate molecule, called podoplanin, binds to the CLEC-2 platelet receptor protein very much like the venom molecule does. Discovered in 1990, podoplanin is a protein expressed on the surface of cancer cells, and, when bound to the CLEC-2 receptor on platelets, it spurs blood clotting, too.

“To shield themselves from the immune system, cancer cells send out a chemical, podoplanin, which binds to the CLEC-2 receptor protein on platelets, telling the platelets to get together and form a protective barrier around the cancer cells. Once enveloped, the cancer cells are not detected by the immune system and are able to bind to blood vessels’ inner linings and spread, or metastasize, throughout the body,” she explained.

Using a mouse model, the team in 2008 showed that blocking the tumor protein podoplanin from binding with the platelet receptor protein CLEC-2 could prevent tumors from metastasizing to the lung.

From snake venom to platelets to tumors

The recent investigations by the team, published in the JBC online July 4, hinged on the generation and study of genetically engineered mouse embryos that lacked the platelet receptor protein CLEC-2. In the end, the experiments showed that CLEC-2 is not only necessary for blood clotting but also necessary for the development of a different type of vessel, specifically lymphatic vessels that carry fluid away from tissues and prevent swelling, or edema.

“During fetal development, the CLEC-2 deficiency disturbed the normal process of blood clotting and, in fact, the normal development and differentiation of blood and lymphatic vessels,” says Masanori Hirashima, an associate professor at Kobe University. “They had disorganized and blood-filled lymphatic vessels and severe swelling.”

Podoplanin, Hirashima explains, is also expressed on the surface of certain types of lymphatic cells and is known to play a role in the development of lymphatic vessels: “These findings suggest that the interaction between CLEC-2 and podoplanin in lymphatic vessels is necessary for the separation between blood vessels and lymphatic vessels.”

It has been known that tumors generate blood vessels to promote their growth, and it’s possible that the formation of lymphatic vessels also may contribute to the spread of cancer throughout the body, says Osamu Inoue, an assistant professor at the University of Yamanashi.

“We speculate that the interaction between the platelet’s CLEC-2 protein and the podoplanin molecule in lymphatic cells plays an essential role in the creation of lymphatic vessels, thereby facilitating tumor growth. If this is the case, a drug that blocks that interaction would prevent the spread of tumors through lymphatic vessels,” Inoue said.

By being deemed a “Paper of the Week,” the team’s work is categorized in the top 1 percent of papers reviewed by the JBC editorial board in terms of significance and overall importance. Other contributors included Guo Ding, Satoshi Nishimura, Kazuya Hokamura, Koji Eto, Hirokazu Kashiwagi, Yoshiaki Tomiyama, Yutaka Yatomi and Kazuo Umemura.

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What is Hoodia Gordonii?

Latin Name: Hoodia gordonii
Other Names: hoodia, xhooba, !khoba, Ghaap, hoodia cactus, South African desert cactus

Hoodia (pronounced HOO-dee-ah) is a cactus-like plant that grows primarily in the semi-deserts of South Africa, Botswana, Namibia, and Angola.

In the last few years, hoodia has been heavily marketed for weight loss and has become immensely popular.

Although there has always been a demand for diet pills, after the ban on the herb ephedra, the market was particularly ripe for the next new diet pill.

Much of hoodia’s popularity stems from claims that the San Bushmen of the Kalahari desert relied on hoodia for thousands of years to ward off hunger and thirst during long hunting trips. They were said to have cut off the stem and eat the bitter-tasting plant.

Hoodia gordonii grows in clumps of green upright stems. Although it is often called a cactus because it resembles one, hoodia is actually a succulent plant.

It takes about five years before hoodia gordonii’s pale purple flowers appear and the plant can be harvested.

There are over 13 types of hoodia. The only active ingredient identified so far is a steroidal glycoside that has been called “p57″. Currently, only hoodia gordonii is thought to contain p57.

What is the History of Hoodia Gordonii?

In 1937, a Dutch anthropologist studying the San Bushmen noted that they used hoodia gordonii to suppress appetite. In 1963, scientists at the Council for Scientific and Industrial Research (CSIR), South Africa’s national laboratory, began studying hoodia. They claimed that lab animals lost weight after they were given hoodia gordonii.

The South African scientists, working with a British company named Phytopharm, isolated what they believed to be an active ingredient in hoodia gordonii, a steroidal glycoside, which they named p57. After obtaining a patent in 1995, they licensed p57 to Phytopharm. Phytopharm has spent more than $20 million on hoodia research.

Eventually pharmaceutical giant Pfizer learned about hoodia and expressed interest in developing a hoodia drug. In 1998, Phytopharm sub-licensed the rights to develop p57 to Pfizer for $21 million. Pfizer returned the rights to hoodia to Phytopharm, who is now working with Unilever.

Much of the hype about hoodia started after 60 Minutes correspondent Leslie Stahl and crew traveled to Africa to try hoodia. They hired a local Bushman to go with them into the desert and track down some hoodia. Stahl ate it, describing it as “cucumbery in texture, but not bad.” She reported that she lost the desire to eat or drink the entire day. She also said she didn’t experience any immediate side effects, such as indigestion or heart palpitations.

Where is Hoodia Gordonii Found?

Hoodia gordonii is sold in capsule, powder, liquid, or tea form in health food stores and on the Internet. Hoodia is also found in the popular diet pill Trimspa.

Despite its popularity, there are no published randomized controlled trials in humans to show hoodia is safe or effective in pill form.

One study published in the September 2004 issue of Brain Research found that injections of p57 into the appetite center of rat brains resulted in altered levels of ATP, an energy molecule that may affect hunger. The animals receiving the P57 injections also ate less than rats that received placebo injections. However, this was an animal study and injections in the brain are different from oral consumption, so it cannot be used to show that oral hoodia can suppress appetite in humans.

The manufacturer Phytopharm cites a clinical trial involving 18 human volunteers that found hoodia consumption reduced food intake by about 1000 calories per day compared to a placebo group. Although intriguing, the study wasn’t published or subjected to a peer-review process, so the quality of the study cannot be evaluated.

What are the Side Effects of Hoodia?

There are some potential side effects of hoodia that you should be aware of. What are Hoodia’s Side Effects and Safety Concerns?

How do I Know if it’s Pure Hoodia?

There are widespread reports of counterfeit hoodia products. Mike Adams of News Target, estimates that 80% of hoodia products are contaminated or counterfeit. It’s impossible to know if a hoodia product contains pure hoodia and the active ingredient, unless it has been tested by an independent laboratory.

After looking at hoodia buyer’s guides, hoodia ratings, and hoodia comparisons on the Internet, my advice is that you be very cautious. Most of these sites have been secretly created by companies selling hoodia. They explain why the hoodia in other products is inferior, even though there are no published reports showing that one is more effective. Q&A: How Do I Know if it’s Pure Hoodia or a Fake?

Sourced & published by Henry Sapiecha

Saving Eyes

Ocular Oncologists Inject Drug Into Eye

To Starve Tumors And Save Sight

October 1, 2008 — Ocular oncologists adopted a drug originally intended to treat colon cancer as a treatment for cancers in the eye as well as macular degeneration. The drug reduces abnormal blood vessel growth, which starves tumors and stops blood vessels from leaking. This interrupts the processes that would, if not stopped, greatly damage patients’ vision.

Whether it’s cancer or macular degeneration, many times patients must face the reality that they will go blind. Now, a new treatment is helping save their sight.

The first thing everyone notices about Dove Karn is her beautiful blue eyes — and it was in Central Park where she came to terms with the fact that she had melanoma in one of those very eyes.

Her tumor was treated with radiation — but the side effects could destroy her vision. Ocular oncologist Paul Finger turned to a new drug to stop Dove’s vision from slipping away.

“It’s a real paradigm shift — like antibiotics were for infections,” says Paul Finger, M.D., an ocular oncologist at the New York Eye Cancer Center in New York City. “This anti-blood-vessel drug is saving people’s vision.”

Avastin is a shot given directly into the eye. It starves the tumor by stopping the growth of abnormal blood vessels that normally would feed the tumor.

“Avastin stops new blood vessels from growing, but it also prevents new and old blood vessels from leaking — and the leaking is what takes away most of the patient’s vision,” Dr. Finger said.

Dove will need to get shots every 6 to 8 weeks, indefinitely — but she says it’s worth it.

“This year was the year that I could say I’m in remission,” Karn said. “I have a full-time teaching job. My children are fabulous — life is wonderful right now.”

ABOUT CANCER IN THE EYE: Ocular melanoma — eye cancer — is a particularly rare and aggressive form of cancer that attacks the pigment cells in the retina. There are essentially two types of intraocular melanoma: low-grade tumors, which grow slowly and rarely metastasize, and high-grade tumors, which grow more quickly and metastasize at a very early stage. Once a tumor metastasizes, the cancer spreads quickly to the liver and other organs, and a patient has only 6 to 12 months to live in the worst cases, although some can survive for as long as 5 years. The National Eye Institute estimates some 2,000 newly diagnosed cases of ocular melanoma occur per year in the United States and Canada –roughly seven in one million people. It affects people of all ages and races, and is not hereditary. Ocular melanoma kills nearly half of those who develop it.

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Morphine Blocks Tumor Growth,

Study Suggests

Science (July 28, 2010) — Current research suggests that taking morphine can block new blood vessel and tumor growth. The related report by Koodie et al, “Morphine suppresses tumor angiogenesis through a HIF1?/p38MAPK pathway,” appears in the August 2010 issue of the American Journal of Pathology.

Morphine is currently the gold standard of analgesics used to relieve severe pain and suffering. Angiogenesis, or new blood vessel growth, is critical for tumor progression from dormant to malignant. Morphine is commonly used to treat cancer pain, but the effects of morphine use on new blood vessel and tumor growth remain controversial.

Using a clinically relevant morphine dose in a mouse model of Lewis lung carcinoma, researchers led by Dr. Sabita Roy of the University of Minnesota Medical School in Minneapolis, MN examined the effect of morphine use on new blood vessel growth in tumors. They found that chronic morphine use decreased levels of tumor angiogenesis in a manner dependent on the opioid receptor. This effect was mediated by suppression of signaling induced by low oxygen concentrations, leading to a reduction in the levels of pro-angiogenic factors. Therefore, morphine may not only serve as an analgesic for cancer patients, but may also inhibit tumor angiogenesis and growth.

Koodie et al conclude that “morphine is a potential inhibitor of tumor growth, through the suppression of tumor cell-induced angiogenesis and hypoxia-induced p38 MAPK activation of HIF-1. In addition to its analgesic potential, morphine can be exploited for its anti-angiogenic potential in cancer pain management; these findings support the use of morphine for cancer pain management.”

This work was supported by the National Institutes of Health

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Protein could battle Alzheimer’s disease

NEW YORK (UPI) — U.S. researchers say they are looking at a new approach to treating Alzheimer’s disease with a protein thought to extend lifespan in laboratory animals.

Scientists at the Massachusetts Institute of Technology said that in mice prone to developing Alzheimer’s, activating a protein called sirtuin suppressed the disease and destroying the protein made the disease much worse, The New York Times reported.

The finding raises the hope that Alzheimer’s, and possibly other neurodegenerative diseases like Parkinson’s and Huntington’s, could be treated with drugs that activate sirtuin, researchers say.

“We think it is a scientifically compelling story that ties the sirtuins to the biology of Alzheimer’s disease,” said Dr. Dennis J. Selkoe, an Alzheimer’s expert at Harvard Medical School who was not a part of the study.

Drugs that activate sirtuin already exist, including resveratrol, a minor ingredient of red wine and other foods.

One drug company, Sirtris, is in preclinical trials with sirtuin-activating drugs.

“We think it has very significant potential in neurodegenerative diseases,” Sirtris Chief Executive Officer George P. Vlasuk said.

Copyright 2010 by United Press International

Sourced & published by Henry Sapiecha

Plant Extract May Be Effective Against

Inflammatory Bowel Disease

Science (July 11, 2010) — A South Dakota State University scientist’s research shows an extract made from a food plant in the Brassica family was effective in alleviating signs of ulcerative colitis, an inflammatory bowel condition, in mice.

The ongoing study by associate professor Moul Dey in SDSU’s Department of Health and Nutritional Sciences — funded by the National Institutes of Health — moves on now to examine the potential use of the plant extract against colon cancer.

“There is an established link between ulcerative colitis and colon cancer. People who have ulcerative colitis are at significantly higher risk to have colon cancer,” Dey said. “Whether this plant extract might help with colon cancer symptoms directly or perhaps delay the onset of colon cancer in ulcerative colitis patients, we don’t know the answers to those questions, but it is something we would like to look into.”

Dey and her team will carry out that research over the next two and a half years as she continues her work on a Pathway to Independence award for promising young scientists. That National Institutes of Health grant of nearly $900,000 over five years was awarded to Dey for work she began as a researcher at Rutgers University.

As a researcher at Rutgers starting in 2004, Dey developed a mammalian cell-based screening platform and screened nearly 3,000 plant extracts for potential anti-inflammatory activity. A plant-derived compound called Phenethylisothiocyanate, or PEITC, was one among others that showed potential anti-inflammatory activities. The NIH funded Dey’s proposal to study it further.

PEITC is found in the Brassica genus of plants, which includes cabbage, cauliflower, watercress and broccoli. Barbarea verna, also known as upland cress or early wintercress, a herb that is used in salads, soups, and garnishes, is one of the richest sources of dietary PEITC in Dey’s study.

Scientists had already studied the compound for its anticarcinogenic properties prior to Dey’s investigation on its anti-inflammatory activities.

“I tested this substance in a mouse model that is already established and widely used. What we found is that it not only alleviates several clinical signs of ulcerative colitis — for example, it attenuates the damage that occurs in the colon tissues and colon epithelium, as well as the clinical signs like diarrhea and blood in stool. The weight loss is a major sign in colitis and that was alleviated, too.” However, she noted that although mammalian animal models are routinely used for an initial test of biological effects of compounds targeted for potential human use, obtained results may not always repeat in humans.

Inflammatory bowel disease, or IBD, is a set of chronic and relapsing inflammatory disorders of the intestine that affects an estimated 2 million people annually in the United States. Two common forms of IBD are Crohn’s disease and ulcerative colitis.

When Dey and her colleagues looked into the mechanism by which the compound might be working against IBD, they found that it downregulates many of the genes that are known to be upregulated in human patients with colitis. That means the compound acts on cells to decrease the quantity of cellular components such as specific proteins that are produced abundantly in colitis patients. One such protein is a novel transcription factor. Transcription factors are one of the groups of proteins that read and interpret the genetic “blueprint” in the DNA.

“We are excited about these findings and our next step would be to see how this plant and the compounds from this plant may be effective against colon cancer, alleviating colon cancer or preventing the onset of colon cancer,” Dey said.

“I am not a cancer biologist per se. My interests are really in cellular mechanisms of inflammatory diseases. The only reason we are going to study colon cancer in this particular project is because ulcerative colitis is very closely linked to colon cancer.”

Colon carcinogenesis is highly preventable, yet colon cancer has one of the highest death rates among all cancers due to typical late diagnosis.

Since people already eat vegetables containing PEITC, there is a long history of human consumption with no adverse effects.

“Obviously the dose we are testing is significantly higher than what we eat in a vegetable, but we have done multiple safety tests and found that this dose is safe in animals,” Dey said.

Dey has no plans to test the extract in humans as part of the current project, but said additional tests would be required if the extract leads to new drugs or treatments in humans.

Dey’s co-authors are Peter Kuhn of Phytomedics Inc., of Jamesburg, N.J.; David Ribnicky, Kenneth Reuhl and Ilya Raskin of Rutgers University, and VummidiGiridhar Premkumar, who is currently at University of Cincinnati

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Substance may block cancer cell growth

COLUMBUS, Ohio (UPI) — A substance produced when eating broccoli and Brussels sprouts may block the growth of cancer cells, U.S. researchers say.

Scientists at the Ohio State University Comprehensive Cancer Center say study evidence suggests the substance, indole-3-carbinol, known as I3C, may have anti-cancer effects, a university release said Tuesday.

The laboratory study discovered a connection between I3C and a molecule called Cdc25A, which is essential for cell division and proliferation, the release said.

“Cdc25A is present at abnormally high levels in about half of breast cancer cases, and it is associated with a poor prognosis,” says study leader Xianghong Zou, assistant professor of pathology at the Ohio State University Medical Center.

The study, published in the journal Cancer Prevention Research, said I3C destroyed the molecule and blocked the growth of breast cancer cells.

The molecule also occurs at abnormally high levels in cancers of the prostate, liver, esophagus, endometrium and colon, in non-Hodgkin lymphoma, and in other diseases such as Alzheimer’s disease, Xianghong noted.

“I3C can have striking effects on cancer cells,” he said, “and a better understanding of this mechanism may lead to the use of this dietary supplement as an effective and safe strategy for treating a variety of cancers and other human diseases.”

Copyright 2010 by United Press International

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Coffee Drinking Associated

With Lower Risk For

Alcohol-Related Liver Disease

Science (June 13, 2006) — Drinking coffee may be related to a reduced risk of developing the liver disease alcoholic cirrhosis, according to a report in the June 12 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Cirrhosis progressively destroys healthy liver tissue and replaces it with scar tissue. Viruses such as hepatitis C can cause cirrhosis, but long-term, heavy alcohol use is the most common cause of the disease in developed countries, according to background information in the article. Most alcohol drinkers, however, never develop cirrhosis; other factors that may play a role include genetics, diet and nutrition, smoking and the interaction of alcohol with other toxins that damage the liver.

Arthur L. Klatsky, M.D., and colleagues at the Kaiser Permanente Medical Care Program, Oakland, Calif., analyzed data from 125,580 individuals (55,247 men and 70,333 women) who did not report liver disease when they had baseline examinations, between 1978 and 1985. Participants filled out a questionnaire to provide information about how much alcohol, coffee and tea they drank per day during the past year. Some of the individuals also had their blood tested for levels of certain liver enzymes; the enzymes are released into the bloodstream when the liver is diseased or damaged.

By the end of 2001, 330 participants had been diagnosed with cirrhosis, including 199 with alcoholic cirrhosis. For each cup of coffee they drank per day, participants were 22 percent less likely to develop alcoholic cirrhosis. Drinking coffee was also associated with a slight reduction in risk for other types of cirrhosis. Among those who had their blood drawn, liver enzyme levels were higher among individuals who drank more alcohol, indicating liver disease or damage; however, those who drank both alcohol and coffee had lower levels than those who drank alcohol but did not drink coffee, with the strongest link among the heaviest drinkers.

Tea drinking was not related to reduced risk in the study, suggesting that it is not caffeine that is responsible for the relationship between coffee and reduced cirrhosis risk. “Previous reports are disparate with respect to whether the apparently protective coffee ingredient is caffeine; in our opinion this issue is quite unresolved,” the authors write.

The findings do not suggest that physicians prescribe coffee to prevent alcoholic cirrhosis, the authors continue. “Even if coffee is protective, the primary approach to reduction of alcoholic cirrhosis is avoidance or cessation of heavy alcohol drinking,” they conclude. “Assuming causality, the data do suggest that coffee intake may partly explain the variability of cirrhosis risk in alcohol consumers. Basic research about hepatic coffee-ethanol interactions is warranted, but we should keep in mind that coffee might represent only one of a number of potential cirrhosis risk modulators.”

(Arch Intern Med. 2006;166:1190-1195. Available pre-embargo to the media at www.jamamedia.org.)

This study was supported by a grant from the Kaiser Foundation Research Institute. Data collection from 1978 to 1985 was supported by a grant from the Alcoholic Beverage Medical Research Foundation, Baltimore, Md.

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New Evidence That Drinking Coffee

May Reduce the Risk of Diabetes

Science (June 10, 2010) — Scientists are reporting new evidence that drinking coffee may help prevent diabetes and that caffeine may be the ingredient largely responsible for this effect. Their findings, among the first animal studies to demonstrate this apparent link, appear in ACS’ Journal of Agricultural and Food Chemistry.

Fumihiko Horio and colleagues note that past studies have suggested that regular coffee drinking may reduce the risk of type 2 diabetes. The disease affects millions in the United States and is on the rise worldwide. However, little of that evidence comes from studies on lab animals used to do research that cannot be done in humans.

The scientists fed either water or coffee to a group of laboratory mice commonly used to study diabetes. Coffee consumption prevented the development of high-blood sugar and also improved insulin sensitivity in the mice, thereby reducing the risk of diabetes. Coffee also caused a cascade of other beneficial changes in the fatty liver and inflammatory adipocytokines related to a reduced diabetes risk. Additional lab studies showed that caffeine may be “one of the most effective anti-diabetic compounds in coffee,” the scientists say.

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