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Tonalin ® CLA FDIN Se minar Food & Ingredients for Weight Management June 28, 2007 Juergen Gierke. The metabolic syndrome : generation XXL. Source :The Economist. Agenda. Properties and origin of Tonalin CLA Clinical studies, efficacy and mode of action Technical hurdles to solve
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Tonalin® CLAFDIN Seminar Food & Ingredients forWeight ManagementJune 28, 2007 Juergen Gierke
The metabolic syndrome : generation XXL Source :The Economist
Agenda Properties and origin of Tonalin CLA Clinical studies, efficacy and mode of action Technical hurdles to solve Product forms and Applications Market Products and Concepts Successful launch and PLM
What is CLA ? • In 1978, Drs. Michael Pariza and Mark Cook of the University of Wisconsin discovered CLA as a beneficial substance extracted from beef with anti-carcinogenic properties. • Rats fed CLA had significantly less abdominal fat than those on an identical diet and exercise program, apart from the CLA. • This observation spawned hundreds of lab and animal studies, and numerous human clinical studies • CLA is a naturally-occurring fatty acid found in meat and dairy fats. • Ruminant animals have a special digestive system that converts linoleic acid into CLA. • CLA formed from linoleic acid in the rumen
Origin and Production of Tonalin CLA Tonalin CLA is prepared from safflower oil, which has the highest concentration of linoleic acid Low temperature processes guarantee the unique high quality The product is distilled several times to remove all impurities ensuring a 100% lipid ingredient which is very low in contaminants Scientific name: Carthamus tinctorius L. COMPOSAE
Product Purity of Tonalin CLA • Comprised of a 50:50 mixture of the two bioactive isomers:cis-9, trans-11 and trans-10, cis-12 • High concentration (80%+) of natural CLA • Patent: CLA composition, low undesirable, non-naturally occurring isomers <1% of non-naturally occurring isomers
Biological Active CLA Isomers trans-10, cis-12 cis-9, trans-11
Muscle Cell Mitochondria Dietary Fat (TG, FFA) Energy -oxidation CPT CLA PancreaticLipase FFA TG FFA CLA TG TG LPL TG TG TG TG TG TG Chylomicron Adipocyte Effects of CLA Stomach Small Intestine
Tonalin®CLA summarized mode-of-action • CLA helps reduce body fat Decreasing the amount of fat stored after eating (decreases LPL) Increasing the rate of fat burning in the mitochondria (CPT and ß-oxidation) Decreasing the total number of fat cells (apoptosis) assumed Reducing proliferation and differentiation of preadipocytes to mature adipocytes • CLA helps maintain lean body mass and protects muscle tissue from tear-down Decreasing markers of muscle protein breakdown Reducing the release of pro-inflammatory cytokines Improving insulin-stimulated glucose transport (energy supply) into muscle
Tonalin® CLA - The CLA with consistent clinical evidence for body composition 14 clinical studies published in peer-reviewed journals 3 more papers in preparation (or submitted for publication) In European, American and Asian populations All studies show consistent results: Reduction of body fat mass (3-9%) & maintenance of lean body mass In lean, overweight and obese subjects Supplementation periods 3-24 months Well tolerated (no severe adverse events) Improved feeling of satiety & of general mood
Tonalin CLA reduces body fat in healthy exercising adults (Thom et al., 2001) Objective Determine the efficacy and tolerability of daily CLA intake in healthy exercising humans Design • 20 healthy humans (M/F); BMI < 25kg/m2 • Randomized, double-blind, placebo controlled (hydrogel) • Standardized physical exercise for 90 minutes three times/week • 1.8 g CLA/day or placebo • 12 weeks Results • Body fat was by 20 % in the CLA group vs. placebo(from 22 % to 17.5 % body fat) • Reduction in body weight 1.9 kg n.s. (near infrared)
* * * *p<0.01 CLA vs. placebo CLA shows dramatic effects when combined with exercise
Long-term study Tonalin® CLA – a Cognis milestone(Gaullier et al. 2004 & 2005) Objective Determine long-term safety and efficacy of CLA supplementation on BFM and LBM in overweight adults Design Year One • 180 (M/F); 25<BMI<30 kg/m2 • Randomized, double-blind, placebo controlled • 3.4g CLA (4 pills)/day or placebo • 12 months Year Two • All groups= 3.4 g CLA-TG (4 pills)/day
CLA reduces body fat by up to 9 % and prevents yo-yo effect 0 12 24 Months
Key messages of the Gaullier study • Tonalin CLA is well tolerated and is safe over a period of 24 months supplementation • No more adverse events than in placebo group • No changes of blood profile outside clinical tolerance levels • 1 year supplementation with Tonalin CLA reduces body fat mass by 9%, compared to placebo • Continuous supplementation with CLA for one more year keeps body fat off • “The study confirms that CLA decreases body fat mass in overweight humans, and may help maintain initial reductions in BFM and weight in the long term.” JM Gaullier (principal investigator)
*p<0.05 CLA (n = 22) vs. placebo (safflower, n = 18) Tonalin CLA prevents holiday weight gain(“Schoeller-Study”, 2006) New *
Key messages of the Schoeller study • Six months of Tonalin CLA significantly decreased fat mass and body weight. • Subjects on Tonalin CLA lost body weight while those on placebo gained weight • Subjects on Tonalin CLA have significant less weight gain due to holiday season (Christmas) compared to placebo group • Subjects on Tonalin saved protein and burned more fat compared to placebo • Resting metabolic rate increased significantly in the CLA group • CLA may help prevent weight gain due to holiday season and with regular aging process
Meta analysis confirms: Tonalin CLA is effective(Whigham et al. 2007) The majority of studies included (15) have been conducted with Tonalin CLA (12) Fat loss is linear within first 6 months Average fat loss is calculated as… -50 g BFM per week (at 3.4 g CLA/d) Respectively -90 g BFM per week if compared to placebo
Technical hurdles to solve Homogenous distribution by double homogenisation or by side-stream feeding Analytical hurdles method development for CLA isomers Sensory a) by taste-masking b) by encapsulation c) further refining Stability thermal stability pH stability storage stability sensorical stability
Tonalin® CLA Product Range Cognis offers Tonalin® CLA in the most complete formulation range available, in free fatty acid,triglyceride and powdered formulations. * mainly food supplements
Tonalin® CLA Products-Applications Instant Powder Applications
Tonalin® CLA Products-Applications Food Applications
Tonalin® CLA Products-Applications Beverage Applications
Market Products with CLA Food Products Milks, yogurts, biscuits Supplements Soft and hard shell capsules, tablets, sachets and others In-Between Nutrition bars, instant beverages, Categories beverage-like products, confectionery-type products (soft chews)
Food Products with CLA Product Dairy Brand NATURLinea Company Asturiana Region Spain Source: Innova Food and Beverage Worldwide New Products Database, www.innova-food.com
Food Products with CLA Product Yoghurt drink Brand Lipowell Company Elsdorfer Region Germany Source: Innova Food and Beverage Worldwide New Products Database, www.innova-food.com
Food Products with CLA Product Milk Brand La Serenisima Company Mastellone Hnos. S.A. Region Argentina Ingredients CLA, calcium concentrate, vitamins A and D Source: Innova Food and Beverage Worldwide New Products Database, www.innova-food.com
Food Products with CLA Product Biscuits Brand nova forma Company Virginas S.A. Region Spain Source: Innova Food and Beverage Worldwide New Products Database, www.innova-food.com
Food (Supplement) Products with CLA Product Nutrition bar / Instant beverage Brand Myoplex Plus Deluxe Company EAS (Ross Products) Region UK/USA and other Source: Innova Food and Beverage Worldwide New Products Database, www.innova-food.com
The First Functional Food Products Branded with Tonalin® CLA The Company - Central Lechera Asturiana • No. 1 Spanish dairy company Products (launched in April/2004) • Skimmed milk (0.75% Tonalin® CLA) • Orange juice with milk (0.75% Tonalin® CLA) • Yoghurt & drink yoghurt (1.87% Tonalin® CLA)
NaturLínea Health Claims Claims • Helps reduce body fat • Effects of Tonalin® CLA clinically proven Recommended Daily Intake = 1.5 grams • 1 glass of milk / juice (250 ml) • 1 yoghurt (100 grams) / drink yoghurt (100 grams)
NaturLínea Product Positioning "Entra con NaturLínea en la nueva era del bienestar natural" • Body shaping • Wellness • Natural source products • Mass Marketing-TV spots • Health Marketing
NaturLínea The NaturLínea Formula + Exercise + Healthy diet = Reduction of body fat
The Consumer of “NaturLínea con Tonalin“ • Characteristics: • 41 years in average: 18 – 25 years: 9.7 % 26 – 40 years: 40.9 % 41 – 65 years: 46.6 % > 65 years: 2.3 % Women (83 %) Weight 68 kg Referred BMI: < 25: 52 % → normal weight 25 – 30: 35 % → overweight > 30: 13 %→ obese Target group Target group