CLA’s success rests on science

In the weight-management wars in a post-ephedra world, CLA is rising to the top of the ingredient heap for supplements. Can it stay there? And will it break into foods? Patrick McGuigan investigates

With obesity continuing to dominate headlines around the world, an ingredient that promises to reduce body fat and increase lean muscle mass would seem to be a sure-fire bet for commercial success. Yet conjugated linoleic acid (CLA) has shown steady rather than spectacular growth. Supplements brands have been willing to develop products with the ingredient, but functional foods companies have been less eager, with only one product so far in Europe and a handful in the US.

CLA is supplied by Cognis, Lipid Nutrition and PharmaNutrients under tightly controlled patent licensing agreements involving the Wisconsin Alumni Research Foundation (WARF) of the University of Wisconsin-Madison. The reasons why food companies have been slower to run with CLA are complex.

Traditionally, food companies are conservative in using new ingredients, compared to their supplements counterparts, because of the higher regulatory hurdles and levels of investment required.

CLA is also a relatively expensive ingredient costing up to $60 per kg. In addition, it takes time and money to educate and convince consumers about a new ingredient. This is particularly hard in the diet category where ?miracle? slimming drugs have often proved ineffective in the past.

At Cognis in Germany, which supplies CLA under the Tonalin brand, Dr Franz Timmermann, global market segment manager for functional foods, says: ?Sometimes food companies hesitate to be first to market, preferring to see others take the initiative and how successful they are. Nonetheless, Cognis has projects in the pipeline with our customers, and we expect launches to follow.?

The wariness of functional foods companies in Europe is confirmed by John Kurstjens, marketing manager at Lipid Nutrition in the Netherlands (part of Loders Croklaan), which supplies CLA under the Clarinol brand. He says: ?The legal situation in Europe is complicated; what food companies can claim is not clear. In the US a lot of companies are waiting for us to get full (FDA-reviewed) GRAS status, which we expect to achieve later this year.?

Gauging the size of the market for CLA is not easy. In Nutrition Business Journal?s 2004 Sports Nutrition and Weight Loss Report, Cognis? Kathleen Grassi, marketing manager for Asia Pacific, estimates the global market for CLA to be worth $150-$200 million a year in retail sales, with 70 per cent of those in the US.

According to Datamonitor?s Productscan service, there were 40 products containing CLA introduced in the US market in 2003 and 37 last year. In Europe, only three were launched in 2003, and seven in 2004.

Sales of CLA will undoubtedly be helped by last year?s news that Clarinol and Tonalin both achieved self-affirmed GRAS status. But as Kurstjens points out, food companies may be waiting for full GRAS status before completely embracing the ingredient.

Studies beget marketing
Confidence in CLA was also helped by a year-long human study published in the American Journal of Clinical Nutrition (Gaullier et al) last year, which found Tonalin reduced body fat mass in overweight adults by as much as nine per cent. The study adds to a growing body of research, which backs up body fat reduction claims for CLA.

More recently, in the April 2005 issue of Journal of Nutrition, the same researchers followed up that one-year trial to report that for the second 12 months, the subjects were able to avoid regaining their fat lost in the first 12 months. The marketing message from this positive trial:

CLA reduces the ?yo-yo? effect dieters experience all too often.

However, there has also been contradictory research showing no effect on body fat. Results from a 12-month human study into the safety of Clarinol, published in Food & Chemical Toxicology (Whigham et al) last year, found that although Clarinol was indeed safe, ?there were no significant changes overall in body weight or body fat between the CLA group and the placebo.? Meanwhile, a review of evidence from animal and human studies on CLA and treating obesity, published in the Journal of Lipid Research, states: ?The present data from human trials does not support any weight loss inducing effect of CLA, and there is no unequivocal evidence of effect on body fat percentage. In addition, it seems CLA may actually induce adverse effects, such as insulin resistance in subjects susceptible to type 2 diabetes.?

A one-year study of 101 obese people, which was recently published in the International Journal of Obesity (Toubro et al), came to the conclusion that ?3.4g (of) daily CLA supplementation does not prevent fat or weight regain after a low calorie diet-induced major weight loss.?

In response to these studies, Cognis says the fat-fighting power of Tonalin CLA has been measured by seven published clinical studies within the last three years, all indicating significant improvement in at least one body composition measurement. About three months of supplementation with Tonalin CLA is typically required to demonstrate a significant reduction in body fat mass, says the company.

?The confusing findings revolve around no effect for body weight. But if the focus is where it should be — on reducing body fat — then the picture becomes much clearer,? says Doris Bell, PhD, manager of the global Tonalin CLA science programme.

Science doesn?t stand still, so it is not uncommon to see conflicting findings

?Science doesn?t stand still, so it is not uncommon to see conflicting findings. Each of the studies has different participant populations, controls and designs, which can explain the conflicting conclusions. In the one-year study by Gaullier et al, which had been designed as a safety study in the first place, the overweight subjects were allowed to keep their regular nutrition regime — and they lost body fat nevertheless, while maintaining lean body mass.

?The other two recently published one-year studies required that people follow a very low calorie diet to induce weight loss of 10kg or more within eight weeks. Such quick weight loss will probably induce a totally different tissue loss, with high risk of losing lean body mass also — a phenomenon nutritionists have warned about for years.

?But, even under these challenging conditions, CLA could prove its beneficial effect: while overall the subjects regained 3.5kg of their initially lost body weight, the subjects taking CLA supplementation had an improved balance between lean body mass and body fat mass, which supports higher fat burning capacity in the muscles, probably assisting in keeping further fat regain off,? Bell says.

At Lipid Nutrition in the Netherlands, senior nutritionist Sandra Einerhand says: ?Up until now, 37 international peer-reviewed papers have been published describing the effect of CLA in different human populations. Different aspects of, in total, 27 human trials are reported in these papers. The dose used varies between 0.7-6.8g CLA per day. The overall outcome of all these trials is that CLA reduces body fat mass and increases lean body mass.

?However, there are indeed examples in which CLA does not have an effect, such as in the Whigham trial. In this case, the?population was overweight and obese?with a BMI of 27-35. The big variation in this population is most likely the reason for the lack of a positive result?on body weight management. The variability was the underlying problem and the heavily obese hardly exercise. It is known that in combination with moderate exercise, CLA works better than in sedentary individuals.?

Comparing studies
Anthony Almada, MSc, founder, president and chief scientific officer of independent consultancy firm IMAGINutrition, is yet to be fully convinced by the science behind CLA. ?CLA is a decade old. It has gone through several resurrections and it keeps coming back,? he says. ?It appears that many consumer products in a food format (noncapsule) do not provide a sufficient dose of CLA (? 3g of CLA/day) from a single serving, raising the question as to the real world efficacy and cost-effectiveness of these delivery forms. There do not appear to be any studies supporting the efficacy of CLA incorporated into food and consumed as directed.

?In addition, human trials of CLA have, in the main, been carried out in countries outside the US, yet the US is CLA?s primary market. Given that people in other countries belong to different gene sets and may respond to diets differently, how can you say with conviction that CLA would work with Americans??

Moving beyond the science debate, the positive results from 2004?s year-long Tonalin study has enabled Cognis to ratchet up its marketing activity. The company launched a global print and public relations campaign to promote the research findings last year with adverts appearing in women?s health and lifestyle magazines. Customer co-promotions have included direct mail programmes and in-store point-of-purchase displays, while a Tonalin radio ad campaign aired on New York stations.

?Educational efforts using scientific studies to make consumers aware of the health benefits and safety behind our products is paramount,? says Nina Likins, Tonalin marketing manager, who is based in Illinois. ?Our marketing messages evolve and strengthen after clinical work is completed.?

Eyeing foods
Lipid Nutrition has also been busy raising awareness of CLA with marketing campaigns and a road show across the US in 2003 called the Clarinol Caravan, hosted by celebrity fitness instructor Greg Isaac. The marketing muscle behind CLA is being backed up by new ingredients formats, such as powder forms for shakes and bars. ?We see CLA-based drinks as a trend for the future, following in the success of pro- and prebiotic drinks and omega-3s, and expect several product launches in Europe,? says Cognis? J?rgen Gierke, marketing manager of beverages in Germany. ?There is also excellent growth potential in the area of soy milks and health shot drinks.?

Lipid Nutrition launched Clarinol A95 in November, which offers active CLA isomers at 95 per cent. The company says that this offers distinct advantages over the conventional 80 per cent active CLA concentration, allowing for a more highly concentrated 1g capsule.

Developing CLA ingredients to suit different products makes sense when one considers that CLA is competing against a wide variety of other diet ingredients, such as Citrus aurantium, 7-keto-DHEA, Garcinia cambogia (hydroxycitric acid) and green tea extract. However, according to Likins, CLA?s advantage is the strength of research behind it.

?CLA shares shelf space with several diet products,? she says. ?It?s not considered a weight-loss supplement; however, its competitors are. Most notably, in the US, the main competitors are Relacore, CortiSlim and Trimspa. Tonalin is heavily researched and backed by clinical science, whereas most of the competition is backed by marketing dollars, not research.

?Typically in the US, these products have a limited lifespan due to the fact that the marketing dollars eventually run out and the next ?big? product comes along. CLA has been on the market since 1996 and continues to grow steadily, as we market responsibly based on clinical research.?

More than fat loss
Chicago-based PharmaNutrients has won the patent for a CLA-based ?cocktail? that may prevent and treat inflammation, osteoarthritis and other degenerative joint diseases.

According to the company, CLA?s ?mechanism of action? mimics that of omega-3 fatty acids, which have been proven to have significant health benefits.

Susie Rockway, PhD, director of research and development at PharmaNutrients, explains: ?The impact of CLA on numerous biochemical parameters in the body clearly demonstrated that this unique fatty acid had a lot more to contribute to health and homeostasis than just fat loss. The ability of CLAOne to reduce the pro-inflammatory cytokines seen in our Penn State study, suggested numerous functions for CLA. We have studies planned to enable us to better understand its mechanism and further validate this technology.?

PharmaNutrients helped develop Tonalin before breaking away from Natural ASA of Norway in 1999.

Food salvos in Europe
Europe?s first functional foods range containing CLA was launched last March by Central Lechera Asturiana in Spain, which brought out Tonalin-enriched yoghurts, milk drinks and orange juice under the NATURLinea brand.

The company claims that its products, thanks to their CLA content, can help reduce body fat. According to marketing manager Juan Povedano, sales have been excellent and the products are now in 72 per cent of all supermarkets. ?We targeted women aged between 30-45 using TV, the press and supermarket demonstrations and sampling,? he says. ?Results have been very good so far, and we are going to launch new products in the range later this year.?

Norwegian company Midelfart is reported to be working on a green tea and CLA drink, while products containing the ingredient in the US include Xenadrine Weight Control Bars, Avon?s SlimWell Chews and Fat Busters Shake from Nature?s Plus.

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