Nutraward winners

DMV?s C12 Peption range regulates blood pressure
A new ingredient range by DMV International was voted as one of two ?ingredients of the year? by Nutracon and SupplyExpo West convention-goers in March. With more than 65 million Americans suffering from high blood pressure, the three products in the C12 Peption range have a wide potential market as a natural blood pressure regulator.

According to studies, a single administration of 1.7g C12 Peption ACE reduces diastolic blood pressure (DBP) by 8mm Hg and systolic blood pressure (SBP) by 6mm Hg in mildly hypertensive people.

The ingredient range couldn?t have come at a better time, said Daniella Witte, product manager. ?It?s a very relevant issue at this moment because the World Health Organization estimates 30 per cent of all adults are suffering from high blood pressure. C12 Peption meets the needs of this population because it?s a natural and effective product without any side effects.?

Unlike other ingredients that target blood pressure, C12 Peption is not botanically based. Instead, it is an enzymatically hydrolysed milk protein whose metabolites inhibit angiotensin converting enzyme. The enzyme is a vasopressor and influences the renal retention of salt and water, both of which help elevate blood pressure.

One of the three C12 Peption products, called C12 Peption AA, also adds alginic acid to the hydrolysed milk protein. So, in addition to inhibiting the angiotensin converting enzyme, it promotes the binding of electrolytes such as sodium, which will then be excreted by the body, reducing blood volume.

With a recommended daily dose of 3.4g, C12 Peption is also unique because it is so fast-acting. ?We have tested positive blood pressure results after only a few hours, whereas some other blood-pressure ingredients don?t see results until eight weeks,? Witte said.

DMV International, based in the Netherlands, first launched C12 Peption in Japan in 2001, with its partner Kanebo. It expanded into Europe in 2003 and the US in 2004. While commonly found in supplements, the ingredients can easily be incorporated into foods. They are currently found in beverages, with discussions now under way in Europe for launches into yoghurts. DMV is also talking with supplements manufacturers in Asia, with the first product launches anticipated later this year.

C12 Peption has GRAS status in the US and doesn?t need novel foods approval in Europe because it is a hydrolysed milk protein. Among the end products available containing the ingredient are Twinlab?s Blood Pressure Control in the US and Springfield?s Regisense in the Netherlands and Belgium.

Clinical evidence
Three major studies have been conducted on C12 Peption. One, published in the American Journal of Hypertension in 2004, was a randomised, double-blind, placebo-controlled trial that investigated the acute dose response effect. Ten subjects received twice-daily doses of either placebo, C12 Peption ACE (1.7g or 3.4g), or C12 Peption AA (1.75g or 3.5g). Blood pressure was measured for six hours after the first dose. A single administration of either C12 Peption ACE or C12 Peption AA reduced both diastolic and systolic blood pressure of mildly hypertensive people. Maximal effects were observed at about four to six hours after intake.

A study in Taiwan investigated the long-term effect of C12 Peption ACE in a double-blind placebo-controlled parallel trial. In each group, 24 subjects were enrolled with prehypertensive blood pressure. The study had a two-week observation period, a four-week treatment period and a two-week end period. Blood pressures and pulse rates were measured once a week in the morning. After four weeks? intake of 3.4g of C12 Peption ACE daily, DBP and SBP were reduced by 7 and 12mm Hg, respectively, with a significant blood pressure lowering effect observed after only one week.

Unigen?s Univestin targets joint inflammation
Univestin, the first ingredient launch by privately held company Unigen Pharmaceuticals, was one of two ingredients to win the NutrAward at this year?s Nutracon and SupplyExpo conventions. Voted on by attendees, the award given by New Hope Natural Media recognizes the best new ingredients of 2004.

Made from a proprietary blend of two plant extracts, Univestin?s ability to improve joint comfort and mobility has been established in five testing models, including gene expression, protein inhibition assays, cell-based studies and in vivo animal models, the company reports.

?This ingredient is the result of many years of research,? explained Regan Miles, executive vice president of the South Korea-based company, whose North American headquarters is in Washington state.

?We are a pretty unique business model in that we apply pharmaceutical science to natural products. We have over 5,000 plants that we break down and use in our search for novel products. Everything we bring to market has human clinical trials behind it, animal safety trials, and we have full genomics as far as how these products work in the body — which genes they up- or down-regulate. We also grow all of our own botanicals on 180,000 acres around the world in Texas, Mexico, China and Russia.?

Univestin works like ?night and day? from the standard chondroitin/glucosamine ingredients used for joint health because its effects are felt within only days, Miles explained. ?This is because it works on multiple inflammation pathways in the body,? he said.

The ingredient is also known for its high antioxidant activity. Brunswick Labs tests found an ORAC value of 5,604umole TE/g, which is higher than both vitamins C and E.

Unigen Pharmaceuticals was founded by a private investor, Bill Lee, in South Korea in 1996, and the company carried out six years of research before taking this, its first product, to market. Today the company has 120,000sq ft of R&D facilities, 35 active scientists, and a target of one or two new product launches each year.

Both of the extracts that comprise Univestin have GRAS status in the US, and Univestin is being considered for novel foods approval in the European Union. First sales of the ingredient in dietary supplements came in January 2003 in the US; by 2004, it had reached Japan and Australia. Dietary supplements for pets were launched in Europe also in 2004, with human supplements awaiting novel foods approval. Then, just this January, Univestin was launched in supplements in Korea.

Major US purchasers include Phillips Health, Twinlabs, Jarrow and Oasis LifeSciences, the latter of which has incorporated Univestin into its first beverage, sold under the AgelessXtra brand.

?That is the only food application it is found in right now, but one company is investigating its potential use in foods,? Miles said.

Univestin is freely soluble in water and polar organic solvents, especially alcohols, and comes in an 80-mesh particle size. It is made up of more than 60 per cent Free-B-Ring flavonoids and 10 per cent flavans. Its recommended dosage is 125mg twice a day.

Behind the science
A randomised, double blind, placebo-controlled trial conducted by JSS Medical Research in Montreal, Canada — which was submitted to a peer-reviewed journal in January — demonstrated both the safety and efficacy of Univestin in relieving symptoms of osteoarthritis.

In the study, 90 subjects were given either placebo or Univestin at a dosage of 500mg/day. Efficacy was measured using the Western Ontario and McMaster (WOMAC) University osteoarthritis index, as well as a health assessment questionnaire. Safety was tested using measures of blood pressure, heart rate, and PTT and faecal occult blood, as well as the frequency and intensity of clinical adverse events. Among the conclusions were that Univestin significantly reduced discomfort and stiffness, and improved joint function within 30 days.

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