Dr. Tim Carr needed a steady supply of beef tallow to take his development of a cholesterol-lowering food additive one step closer to reality. Eldon Roth happened to be seeking a better use for about 20 million pounds of edible beef tallow produced weekly by his company, Beef Products, Inc., Dakota Dunes, S.D. This past March, Carr, a nutrition scientist at the Univ. of Nebraska, Lincoln, and Roth, president of BPI, joined forces to study the effectiveness of the compound in humans, using a by-product of BPI’s lean beef trim operation.

Carr has worked on developing the compound for several years after affirming its cholesterol-lowering attributes in lab tests. He’s discovered a way of synthesizing plant sterols from soybeans and stearic acid from beef tallow into a compound that can be added to food, including ground beef. And now, thanks to the financial backing of Roth — to the tune of $500,000 — a human clinical study on the effectiveness of the compound is under way.

After talks with several potential firms interested in getting involved with the research, BPI stepped up to the plate and was anxious to get started. "We’re not wasting anytime," says Carr, of the aggressive plans to recruit 32 subjects and get the study started by May 17.

"We have been talking to a number of companies, and BPI was interested because our compound utilizes beef tallow," says Carr. "Eldon (Roth) just picked up the phone and called me one day to inquire about it." After several months of discussion, the agreement was made that BPI would fund the human study.

As part of its agreement with the university, at the conclusion of the human study, BPI will have the rights to manufacture the compound exclusively. The details of such an arrangement depend on several factors, including the results of the study. "At this point it’s merely an option agreement" says Carr.

"An article regarding Dr. Carr’s research in Science News magazine caught our attention," says Roth. "We are always interested in reviewing new technologies that may help generate new markets or add value to the edible beef tallow derived from our operations." Considering BPI produces 20 million pounds of edible beef tallow weekly and assuming a 25 percent stearic acid component is available in that tallow, "We generate approximately 5 million pounds of stearic acid each week," Roth says.

Led by Carr, researchers are conducting a placebo-controlled, doubleblind, free-living population study lasting four weeks. The 32 subjects will be divided into two groups, one of which will be given placebos, while the other will be given the compound in the form of a pill. Subjects are between the ages of 19 and 70 years old, with varying cholesterol levels to provide researchers with data about what "typical" results can be expected from people taking the compound.

The subjects will be asked to adhere to their normal lifestyle and dietary habits throughout the four weeks.

"Ultimately, we envision this being in food products as an ingredient," says Carr. "But for this study, we’re just going to put it in capsules, out of convenience for the study." The subjects will take the tablets three times per day and check in with researchers each week during the study.

"We’ve done extensive testing on laboratory animals, and we get a fairly dramatic decrease in L.D.L (low-density lipoprotein, or ‘bad’) cholesterol," says Carr. "We don’t know exactly how humans will respond until we do the human study." There is reason for optimism, however. In lab animals treated with the compound L.D.L. cholesterol levels to have dropped by as much as 79 percent.

"There are several different ways to incorporate the compound into various food products," says Carr. Because the cholesterol-lowering compound is not regarded as a drug, however, F.D.A. approval is not required to market the product as a food ingredient, which is how it is being marketed. "We would need F.D.A. approval if we wanted to make specific health claims about it," Carr says.

Applications in food products could be developed for products already produced by BPI, including ground beef and other meats as well as a component in products such as shortenings, cereals and baked foods.

"With this compound, the potential certainly exists for consumers to lower their bad cholesterol counts by eating beef," says BPI’s Roth. Based on initial findings, the amount of the compound added to any product to achieve the cholesterol-lowering benefits is minute. "We believe the cholesterol lowering benefits of this compound will make it appealing to consumers and processors will promote its presence on their labels," Roth says.

If the research results come back as expected and an agreement is reached between BPI and U.N.L., Carr says products containing the compound could be available to consumers within two years. Carr’s involvement with developing the product at the next level is still up for negotiation.

"I’m a basic researcher and I study how cholesterol moves around in the body and how it ends up in the blood, where we don’t want it," he says, reflecting on his initial interest in developing the compound about four years ago. He adds that his interest in food science and how food regulates cholesterol transport kept him transfixed. "So this (project) was a natural outgrowth of my basic research."

Years later, the thousands of hours of research are shaping up to make a difference in addressing a health problem that affects many people. "It wasn’t an overnight success by any means," Carr says. "It has been the result of a lot of steady research that’s panning out to be a real significant finding."