Extensive research since last 40 years helped to scientifically validate the versatile health benefits of Coleus forskohlii that have long been known in folk medicine.

 

A major breakthrough in research on forskolin was the discovery that Coleus forskohlii root is a clinically effective natural ingredient in the weight management. It has been found that forskolin has the ability to restrain the conversion of calories to fat, due to which the excess calories gets converted to glycogen, which builds muscles attributing to lean body mass.

 

Several studies have validated the positive effects of forskolin in enhancing lean body mass, promoting fat loss and improving the overall body composition.

Several clinical investigations around the world have revealed the supportive role of forskolin for fat reduction and maintaining lean body mass. Although efficacy was the primary purpose of these trials, parameters related to safety were also monitored. The major breakthroughs on the usefulness of forskolin in shredding that extra fat are explained in this section.

INDIA

Twenty-four obese female subjects with BMI ranging from 28–45
(I degree to III degree obesity) were evaluated for the effect of ForsLean® on lean body mass and weight loss. Subjects were given 250 mg of ForsLean® capsules...

JAPAN

In another open-field, 12-week study, ForsLean® (10% diterpene forskolin) was evaluated in overweight volunteers for effect on body composition. ForsLean® was administered in a dose of 125 mg twice a day

USA

Effective mitigation of gains in body mass (p=0.10) and scanned mass (p=0.08) was witnessed when 23 overweight female volunteers were supplemented with ForsLean® in a 12-week, double-blind randomized clinical trial.

Even though natural products or plant extracts have a long history of use in Ayurveda and other traditional medicinal systems, they are not altogether exempted from the quintessential safety evaluation.

 

Coleus forskohlii extracts and forskolin have shown an excellent safety profile and are generally considered safe, non-toxic and without any side effects at the recommended dosage. Prolonged topical application of forskolin is also well tolerated.

 

The safety of ForsLean® for use as a dietary supplement was established by means of detailed toxicological evaluation through in vitro, preclinical and clinical set ups.

  • Data from acute oral toxicity (to determined median lethal dose, LD50, the amount of a toxic agent that is sufficient to kill 50 percent of a population of animals usually within a certain time) (14 days), sub-acute oral toxicity (28 days) and chronic oral toxicity (180 days) revealed that ForsLean® did not produce any signs of toxicity.
  • Based on these findings, it was suggested that LD50 was found to be greater than 2000 mg/kg body weight. Additionally, no-observed-adverse-effect level (NOAEL) of ForsLean® administration over a period of 28 days and 180 days was found to be greater than 1000 mg/kg body weight
  • Bacterial Reverse Mutation Assay with an Independent Repeat Assay (AMES Test) also concluded that ForsLean® was non-mutagenic up to 5000 µg per plate
  • Repeated Insult Patch Test to assess dermal irritation or allergic contact sensitization by 2% w/w forskolin in 45 healthy volunteers of either sex suggested that the observations remained within the normal limits throughout the test interval

IP Rights

A method of promoting lean body mass in an individual is disclosed, comprising administering to the individual a lean body mass promoting effective amount of forskohlin. A method of treating a mood disorder is also disclosed…

Achievements

Sabinsa was conferred with The Nutracon Best Product Award 2001 for ForsLean®, its proprietary ingredient, which has been patented for its use in promoting lean body mass at the Nutracon conference held in San Diego, CA, USA. This award was given based upon its scientific merits.