Hoodia: Herbal Anti-obesity Nirvana or Weight Loss Fraud?
Posted 04-17-2008 at 08:56 AM by szo
Hoodia Gordonii is a succulent spiky plant, roughly the same size and shape as a cucumber. This plant is native to the African Kalahari desert and is considered food by the primitive tribes called the San Bushmen, featured in the movie “Gods must be Crazy”, who call it Xhoba. They have been eating the bitter Hoodia plant for centuries, to suppress hunger and thirst on long hunting trips. The San tribe has been eating this plant for generations by learning from their forefathers. It is their food, water, and medicine. A San, Piet Rooi, stated that he has been eating it since he was nine. He’s now 73 years old.
The Sans use this plant for treating illness as well. A native San woman was seen removing the thorns of the Hoodia plant, and saying that she would crush it into powder to treat her sister’s asthma.
Two BBC correspondents came to Kalahari to personally test the Hoodia. After peeling off the spiky outer layer and eating half of a banana size, they didn’t experience hunger pangs and there was no after effects like racing heart or queasy stomach. It tasted a little bitter with a cucumber texture but amazingly, they regained their appetite 24 hours later. These stories are not isolated anecdotes, but rather, collectively document a long history of food and therapeutic use of Hoodia.
South African scientists, wanting to find out if there is any real science behind this famous plant, took them 30 years to isolate the specific appetite-suppressing ingredient. This molecule is called P57. The scientists applied for a patent and licensed it to Phytopharm, a pharmaceutical and functional food development in UK.
Dr. Richard Dixey of Phytopharm explained that the hypothalamus, located just above the brain stem, has nerve cells that sense glucose. When we eat, the blood sugar level goes up and the cells start firing and send the message that the person is full. He said that Hoodia contains the molecule that is about 10,000 times as active as glucose. This molecule stimulates the hypothalamus to cause those nerve cells to fire as if you were full even you have not eaten, nor do you want to. Dixey tried Hoodia with rats during his first animal trial. Rats are species that will literally eat anything but after the trial, they stopped eating completely. On his phase 1 human trial, the group of individuals taking Hoodia reduced their calorie intake by 1,000 a day after 15 days.
Hoodia, however, will not be available for several years since necessary clinical trials to ensure safety of the extracts takes a few years to complete.
The South African lawyer, Roger Chennells, says, “There’s no need to go to Kalahari to steal this plant as it is hard to find and illegal to export. Internet sites offering Hoodia pills from the US were tested and there was no discernable Hoodia in it.”
There’s a patent on the application of the plant as a weight loss product but no one else can use the Hoodia for weight loss without infringing the patent. Other weight loss products that claim to have Hoodia in it like Trimspa X32, but FDA hasn’t approved about its safety.
Phytopharm reached a development deal with giant-maker Pfizer but the latter abandoned Hoodia when making a pill out of the active ingredient seemed beyond reach. Unilever, one of the world’s biggest manufacturers of brand-name foods, has stepped up in its place. Phytopharm decide to market Hoodia in its natural form, in diet shakes and bars, but this means that they need the Hoodia plant itself. With the obesity epidemic in the US alone, it obviously needs a lot of Hoodia. They started a plantation in South Africa and it was a challenge growing the crop as it was taken out of the wild. They have no experience in dealing with diseases and pests, but Phytopharm has established the plantation for over 5 years now to grow sustainable Hoodia plants under an extensive and sophisticated agronomy programme. These plants were grown exclusively for Phytopharm’s products and the extracts with the active molecule, are the subject of global patenting programme, with major patents granted in the US, UK, Europe and Japan and pending all over territories.
Today, Phytopharm and Unilever have initiated certain Stage 3 activities including supply chain expansion and further safety studies that will evaluate reductions in calorie intake as part of a weight management programme for the general population. Stage 2 activities have included successful progression of clinical safety trials, manufacturing, and plant cultivation.
Richard M. Goldfarb, MD., a doctor in Morrisville, Pa. and the medical director of Bucks County Clinical Research, conducted a small study of Hoodia on 7 people and found if effective. He studied DEX-L10, the 500 mg Hoodia capsule sold by Delmer Labs. The 7 overweight participants took 2 Hoodia (DEX L-10) capsules a day, eat a balanced breakfast and take a multivitamin and continued their exercise and eating habits. The participants lost an average of 3.3% of their body weight and the median loss over the 28-day study was 10 lbs. Most of the participants claimed their caloric intake dropped to less than half within a few days after starting Hoodia and no side effects such as jitteriness or insomnia.
The study was not published because Goldfarb said, it was conducted as an “efficacy” study trying only to find out if the product actually works.
Other Doctors are sceptical and found no conclusive evidence to support the claim of appetite suppression. Dr. Adrienne Youdim, MD., medical director of the Comprehensive Weight Loss program at Cedars-Sinai Medical Center, LA., replied when asked by patients whether they should try Hoodia, “There is no [published scientific] data to support its use. But, similarly, there is no data suggesting adverse effects. It’s kind of uncharted territory.” She doesn’t recommend using the product.
Doctors warn the public or buyers of the Hoodia products sold in the internet, as they aren’t the real thing or they don’t have enough Hoodia. To make sure in finding the real one, experts suggest asking the manufacturers if it sends its Hoodia to an independent lab for testing.
Awareness Corporation (“Awareness”), a Nevada corporation located in Chandler, Arizona, proposes to use Hoodia in a dietary supplement to suppress appetite and presented a notification to the FDA. Awareness started with the flesh of the Hoodia plant and dehydrated it, producing a powder. The powder is not altered chemically from the Hoodia plant flesh in any way. In the proposed appetite suppressant product, this dried Hoodia powder will be used in amount of 300mg per serving and 600mg per day for adults. As a safety evidence presented in the Notification, Awareness concluded that on the said amounts, safety is expected based on the following documentation and scientific evidence: 1) size servings of 35g or more used as food in South Africa; 2) it has been used as food for hundreds of years in South Africa; 3) the proposed new ingredient is not chemically altered from the Hoodia plant, which will make it safe as food use; 4) animal studies showing no toxicity and no abnormalities; 5) a nutritional analysis showing safe use and beneficial minerals in Hoodia; 6) a human clinical trial with no reported adverse events.
The proposed Awareness product would contain this Hoodia powder ingredient at the amount of 300mg per serving, with the suggested Use as two servings per day, and thus an amount of 600mg per day. It is to be used as an appetite suppressant for healthy adults, for weight loss. The label will contain three Cautions, prominently printed in bold type: Not for children under 18. Do not exceed recommended serving size. Do not use if you are pregnant or lactating.
Disclosures and Disclaimers: Please note that while there is evidence of therapeutic properties of Hoodia in the botanical and medical literature, and also of medicinal traditional use of Hoodia among the San Tribe (e.g., for asthma, stomach aches, etc.), no medical or therapeutic use claims will be used in the labelling or the advertising of the proposed Awareness product.
P57, an “active” constituent which has been extracted from the Hoodia plant and is being developed for an anti-obesity drug, however the NDI Hoodia is a botanical ingredient and not an extract, and it’s not to be used to treat obesity. The only claims to be used on the Awareness product label is for reducing appetite, and such suppressant is an adjunct to a sensible diet and moderate exercise.
The FDA is reviewing websites in the internet that promotes Hoodia Gordonii. Any promotion of the products as a drug or intended for use in the cure, mitigation, treatment, or prevention of disease is advised of violating the Federal Food, Drug, and Cosmetic Act (the Act). They also approve those distributors who claim truthful and not misleading statements on their products.
Right now, Hoodia powder is distributed as a natural appetite suppressant, that causes no side effects, and it reduces the appetite for 30%. Again, the use of Hoodia powder as an anti-obesity or any medical treatment is still under investigation. Time will tell when the Hoodia extract is ready for the general population. More intensive trials are to be made for it to become an anti-obesity agent or a treatment to any medical condition.
__________
Sources:
FDA Public Docket
URL: http://www.fda.gov/ohrms/dockets/doc...ani-vol173.pdf
URL: http://www.fda.gov/ohrms/dockets/dai...379-vol125.pdf
The Sans use this plant for treating illness as well. A native San woman was seen removing the thorns of the Hoodia plant, and saying that she would crush it into powder to treat her sister’s asthma.
Two BBC correspondents came to Kalahari to personally test the Hoodia. After peeling off the spiky outer layer and eating half of a banana size, they didn’t experience hunger pangs and there was no after effects like racing heart or queasy stomach. It tasted a little bitter with a cucumber texture but amazingly, they regained their appetite 24 hours later. These stories are not isolated anecdotes, but rather, collectively document a long history of food and therapeutic use of Hoodia.
South African scientists, wanting to find out if there is any real science behind this famous plant, took them 30 years to isolate the specific appetite-suppressing ingredient. This molecule is called P57. The scientists applied for a patent and licensed it to Phytopharm, a pharmaceutical and functional food development in UK.
Dr. Richard Dixey of Phytopharm explained that the hypothalamus, located just above the brain stem, has nerve cells that sense glucose. When we eat, the blood sugar level goes up and the cells start firing and send the message that the person is full. He said that Hoodia contains the molecule that is about 10,000 times as active as glucose. This molecule stimulates the hypothalamus to cause those nerve cells to fire as if you were full even you have not eaten, nor do you want to. Dixey tried Hoodia with rats during his first animal trial. Rats are species that will literally eat anything but after the trial, they stopped eating completely. On his phase 1 human trial, the group of individuals taking Hoodia reduced their calorie intake by 1,000 a day after 15 days.
Hoodia, however, will not be available for several years since necessary clinical trials to ensure safety of the extracts takes a few years to complete.
The South African lawyer, Roger Chennells, says, “There’s no need to go to Kalahari to steal this plant as it is hard to find and illegal to export. Internet sites offering Hoodia pills from the US were tested and there was no discernable Hoodia in it.”
There’s a patent on the application of the plant as a weight loss product but no one else can use the Hoodia for weight loss without infringing the patent. Other weight loss products that claim to have Hoodia in it like Trimspa X32, but FDA hasn’t approved about its safety.
Phytopharm reached a development deal with giant-maker Pfizer but the latter abandoned Hoodia when making a pill out of the active ingredient seemed beyond reach. Unilever, one of the world’s biggest manufacturers of brand-name foods, has stepped up in its place. Phytopharm decide to market Hoodia in its natural form, in diet shakes and bars, but this means that they need the Hoodia plant itself. With the obesity epidemic in the US alone, it obviously needs a lot of Hoodia. They started a plantation in South Africa and it was a challenge growing the crop as it was taken out of the wild. They have no experience in dealing with diseases and pests, but Phytopharm has established the plantation for over 5 years now to grow sustainable Hoodia plants under an extensive and sophisticated agronomy programme. These plants were grown exclusively for Phytopharm’s products and the extracts with the active molecule, are the subject of global patenting programme, with major patents granted in the US, UK, Europe and Japan and pending all over territories.
Today, Phytopharm and Unilever have initiated certain Stage 3 activities including supply chain expansion and further safety studies that will evaluate reductions in calorie intake as part of a weight management programme for the general population. Stage 2 activities have included successful progression of clinical safety trials, manufacturing, and plant cultivation.
Richard M. Goldfarb, MD., a doctor in Morrisville, Pa. and the medical director of Bucks County Clinical Research, conducted a small study of Hoodia on 7 people and found if effective. He studied DEX-L10, the 500 mg Hoodia capsule sold by Delmer Labs. The 7 overweight participants took 2 Hoodia (DEX L-10) capsules a day, eat a balanced breakfast and take a multivitamin and continued their exercise and eating habits. The participants lost an average of 3.3% of their body weight and the median loss over the 28-day study was 10 lbs. Most of the participants claimed their caloric intake dropped to less than half within a few days after starting Hoodia and no side effects such as jitteriness or insomnia.
The study was not published because Goldfarb said, it was conducted as an “efficacy” study trying only to find out if the product actually works.
Other Doctors are sceptical and found no conclusive evidence to support the claim of appetite suppression. Dr. Adrienne Youdim, MD., medical director of the Comprehensive Weight Loss program at Cedars-Sinai Medical Center, LA., replied when asked by patients whether they should try Hoodia, “There is no [published scientific] data to support its use. But, similarly, there is no data suggesting adverse effects. It’s kind of uncharted territory.” She doesn’t recommend using the product.
Doctors warn the public or buyers of the Hoodia products sold in the internet, as they aren’t the real thing or they don’t have enough Hoodia. To make sure in finding the real one, experts suggest asking the manufacturers if it sends its Hoodia to an independent lab for testing.
Awareness Corporation (“Awareness”), a Nevada corporation located in Chandler, Arizona, proposes to use Hoodia in a dietary supplement to suppress appetite and presented a notification to the FDA. Awareness started with the flesh of the Hoodia plant and dehydrated it, producing a powder. The powder is not altered chemically from the Hoodia plant flesh in any way. In the proposed appetite suppressant product, this dried Hoodia powder will be used in amount of 300mg per serving and 600mg per day for adults. As a safety evidence presented in the Notification, Awareness concluded that on the said amounts, safety is expected based on the following documentation and scientific evidence: 1) size servings of 35g or more used as food in South Africa; 2) it has been used as food for hundreds of years in South Africa; 3) the proposed new ingredient is not chemically altered from the Hoodia plant, which will make it safe as food use; 4) animal studies showing no toxicity and no abnormalities; 5) a nutritional analysis showing safe use and beneficial minerals in Hoodia; 6) a human clinical trial with no reported adverse events.
The proposed Awareness product would contain this Hoodia powder ingredient at the amount of 300mg per serving, with the suggested Use as two servings per day, and thus an amount of 600mg per day. It is to be used as an appetite suppressant for healthy adults, for weight loss. The label will contain three Cautions, prominently printed in bold type: Not for children under 18. Do not exceed recommended serving size. Do not use if you are pregnant or lactating.
Disclosures and Disclaimers: Please note that while there is evidence of therapeutic properties of Hoodia in the botanical and medical literature, and also of medicinal traditional use of Hoodia among the San Tribe (e.g., for asthma, stomach aches, etc.), no medical or therapeutic use claims will be used in the labelling or the advertising of the proposed Awareness product.
P57, an “active” constituent which has been extracted from the Hoodia plant and is being developed for an anti-obesity drug, however the NDI Hoodia is a botanical ingredient and not an extract, and it’s not to be used to treat obesity. The only claims to be used on the Awareness product label is for reducing appetite, and such suppressant is an adjunct to a sensible diet and moderate exercise.
The FDA is reviewing websites in the internet that promotes Hoodia Gordonii. Any promotion of the products as a drug or intended for use in the cure, mitigation, treatment, or prevention of disease is advised of violating the Federal Food, Drug, and Cosmetic Act (the Act). They also approve those distributors who claim truthful and not misleading statements on their products.
Right now, Hoodia powder is distributed as a natural appetite suppressant, that causes no side effects, and it reduces the appetite for 30%. Again, the use of Hoodia powder as an anti-obesity or any medical treatment is still under investigation. Time will tell when the Hoodia extract is ready for the general population. More intensive trials are to be made for it to become an anti-obesity agent or a treatment to any medical condition.
__________
Sources:
FDA Public Docket
URL: http://www.fda.gov/ohrms/dockets/doc...ani-vol173.pdf
URL: http://www.fda.gov/ohrms/dockets/dai...379-vol125.pdf
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