The importance of maintaining or regaining lean body mass has recently come to light for two important reasons. First is the increased recognition that lean body mass plays a vital role in any successful weight training regimen. Second, there is a growing awareness that lean body mass is proportionate to the overall health of an individual.

The percentage of lean body mass to fat, or body composition, can be accurately established with a non-invasive analytical method commonly available in specialized health care and sports medicine centres. Lean body mass consists of muscles, vital organs, bone and bone marrow, connective tissue and most of the body water. The proportion of lean body mass to body fat clearly determines our aesthetic looks, but more importantly it determines our physical fitness, health status and the risk of morbidity (disease) and premature mortality for each of us.

Calculating Body-Mass Index There is a practical way of self-assessing body composition called the Body Mass Index (BMI), and is calculated by dividing body weight in kilograms by the height squared in meters. The BMI norm is between 18 and 25 kg/m2. A value over 25 puts a person in the overweight category, and values greater than 30 correspond to varying degrees of obesity. Another valuable self-determined index that corresponds to lean body mass is the waist to hip ratio; the norm for men is 1.0 and for women approximately 0.8.

New Botanical? This paper describes a promising concept for increasing lean body mass and optimizing body composition with a standardized root extract from coleus forskohlii (Fam. Labiatae), a mint family plant that is native to India and indigenous to its Ayurvedic medicine. Although traditionally used as a pickle or food spice, C. forskohlii has gained a new found prominence as the only plant source of diterpene forskolin. Forskolin is known to enhance adenylate cyclase, an enzyme that splits a high energy molecule of ATP to yield cyclic AMP. Nicknamed in literature as a "second messenger", cyclic AMP facilitates the action of a "primary messenger" i.e. various hormonal and/or bioactive substances in the body.

The role of cyclic AMP is indispensable to the functions of the body. It triggers a chain of biochemical events that influence such functions as body metabolism and food induced thermogenesis, yet also provides mechanisms for controlling body composition and lean body mass.

Importance of lean body mass
Although the impact of lean body mass on health has yet to be fully understood, the health promoting value of increasing lean body mass can be appreciated indirectly due to the known benefits derived from physical exercise in building lean body mass and stamina. For this reason, the natural relationship between body composition and one's overall health status has recently become a subject of research interest.

At first glance it does not seem important that lean body mass correlates positively with the performance of an incremental treadmill exercise test, nor that the fat percentage in the abdomen is significantly less in elite athletes in comparison with their non-exercising controls. However, the fact that long-distance runners have very low amounts of fatty tissue in their abdomen becomes of special importance in view of central obesity (abdominal fat) being a recognized risk factor for cardiovascular morbidity and mortality. In other words, since abdominal fatty tissue is a significant risk factor for cardiovascular disease, running may have a positive impact on long-term cardiovascular risk and life span.

A rapidly growing segment of the United States population whose health is most appreciably affected by the imbalance in body composition is the geriatric group, especially those above 75 years of age. As aging diminishes lean body mass, the elderly are especially prone to develop conditions which either further deplete their lean body mass and/or they experience an excess of body fat over lean body mass. For example, hypertension, adult onset Diabetes Mellitus (NIDDM or Type 2), and dyslipidemia increase with advancing age and obesity.

These conditions may, alter body composition with an increase of central obesity and a decrease in lean body mass. It should be noted, that body composition and overall fitness are health predictors for entire populations, regardless of age and gender.

For example, one study examined the health benefits of leanness and the hazards of obesity in men while simultaneously considering fitness, as determined by maximal exercise testing. Interestingly, the unfit, lean men had a higher risk of all-cause and cardiovascular disease (CVD) mortality than men who were fit and obese. Therefore, the health benefits of leanness are limited to fit men, and being fit may reduce the hazards of obesity.

The role of the fitness factor as determined by total serum cholesterol and body mass index were analyzed among 242 cases of breast cancer in a population of over 20,000 Norwegian women during a mean follow-up period of 12 years. Patients whose total serum cholesterol values were elevated and/or who were obese had significantly higher chances of premature death (factor 2) in comparison to normocholesterolemic and/or lean patients. These results suggest that total serum cholesterol and BMI are positively associated with the risk of dying among women who develop breast cancer.

Epidemiological studies indicate that the impact of body composition on health starts early in life. The association between body mass and mortality in over 100,000 American women, 30 to 55 years of age was evaluated. During 16 years of follow-up, 5% of overall deaths were documented with the breakdown including 0.8% from cardiovascular disease, 2.5% from cancer, and 1.7% from other causes. The lowest mortality rate was observed among women who weighed at least 15 percent less than the US average for women of similar age and those whose weight had been stable since early adulthood. In a separate study, it was found that being overweight in adolescence predicted a broad range of adverse health effects that were independent of adult weight after 55 years of follow-up.

Epidemiological studies indicate that the impact of body composition on health starts early in life. The association between body mass and mortality in over 100,000 American women, 30 to 55 years of age was evaluated. During 16 years of follow-up, 5% of overall deaths were documented with the breakdown including 0.8% from cardiovascular disease, 2.5% from cancer, and 1.7% from other causes. The lowest mortality rate was observed among women who weighed at least 15 percent less than the US average for women of similar age and those whose weight had been stable since early adulthood. In a separate study, it was found that being overweight in adolescence predicted a broad range of adverse health effects that were independent of adult weight after 55 years of follow-up.

The experience of ForsLean®, enhanced and translated into LeanGard®
The invention of ForsLean® prompted further discovery of combination of standardized botanical extracts called LeanGard, i.e. guardians of lean body mass. The health benefits derived from the LeanGard formulation are a result of the synergy of four botanical compounds: hydroxycitric acid (HCA), garcinol (both compounds extracted from rinds of Garcinia gambogia), diterpene forskolin (coleus forskohlii root extract) and alkaloid piperine (Piper nigrum fruits extract).

The potential of HCA, a compound derived from the rind of the Garcinia gambogia fruit, as a weight lowering compound has been recognized since the 1970's. However, clinical studies conducted with this compound have produced contradictory results, most likely due to HCA being poorly absorbed and bioavailable inside of the body fat producing cells that inhibit the target enzyme, citrate lyase. This critical issue of HCA absorption and bioavailability in weight management has been addressed in LeanGard by combining HCA with garcinol (polyisoprenylated benzophenone). Garcinol, like HCA, is isolated from Garcinia sp. fruit rind, and has been studied for its anti-oxidant, anti-inflammatory and cancer preventive properties. Garcinol also increases levels of liver detox enzymes, like glutathione S-transferase or quinone reductase activities, which helps normalize metabolism and remove metabolic toxins that hamper weight management benefits.

LeanGard®'s biological mechanism further benefits from the addition of diterpene forskolin, a compound derived from roots of the coleus forskohlii plant, which uniquely regulates body composition by enhancing adenylate cyclase and cAMP cellular levels, leading to an increase in lean body mass and a decrease in the content of body fat. Increased lean body mass up-regulates body metabolism and helps mitigate body weight gain, as well as maintaining the accomplished weight reduction over the long-run, i.e. prevention of the so-called yo-yo effect. It has been recognized recently that diminished lean body mass slows down body metabolism and results in difficulties in maintaining an appropriate and healthy body composition and weight. Thus the synergistic components of LeanGard provide a sensible weight management approach to reduce body weight to acceptable levels by restoring the optimal proportions of fat to lean body mass. By maintaining or increasing lean body mass while simultaneously reducing body fat, the weight loss regimen would serve the general purpose of improving the overall health of the individual. Lean body mass can simply be described as total body weight minus fat and it is inversely correlated with morbidity and mortality rate. LeanGard also provides an additional mechanism to secure gastrointestinal absorption and ultimately bioavailability of all the above discussed ingredients by including in its composition 5 mg of 95% pure alkaloid piperine. Piperine, a pungent compound extracted from black pepper fruits, is known to assist the absorption of a variety of nutrients and also to improve diminished nutrient absorption which typically occurs with aging. In fact, the efficacy of many weight-loss nutraceuticals is known to be diminished in middle-aged and elderly populations.

The therapeutic effects of the individual components of LeanGard evaluated in preclinical and human studies include a reduction in total body weight and body mass index, a reduction in body fat, an increase in lean body mass and content of body water, and a reduction in perceived appetite levels while increasing energy levels. The unique combination of ingredients in LeanGard provides enhanced biological activity of the weight loss components and also in the antioxidant and anti-inflammatory properties of garcinol.

Sabinsa Patent Portfolio Relevant Weightloss products

Citrin®
United States 5,783,603 (1998)
United States 6,770,782 B1 (2004)

GarCitrin®
Australia 773081 (2004)
New Zealand NZ518116 (2005)
United States 7,063,861 (2006)
Europe EP1254209 (2007)

ForsLean®
Unites States 5,804,596 (1998)
Europe EP0977564 (2006)
Canada CA2281562 (2008)

BioPerine®
Unites States 5,536,506 (1996)
Unites States 5,744,161 (1998)
Unites States 5,972,382 (1999)
Unites States 6,054,585 (2000)
Unites States 6,849,645 (2005)
Europe EP0810868 (2005)
Japan JP3953513 (2007)
Canada CA2247467 (2007)