The company behind one of the most promising new entrants to the burgeoning weight management ingredients market is preparing to make a Novel Food application to gain entry into the European market.
Hong Kong-based Gencor Pacific is just waiting for the results from a chronic toxicity study, a chromosomal aberration study and a teratogenicity study on its hunger-busting ingredient Slimaluma, before filing an application, md RV Venkatesh told FIHN.
Slimaluma is an extract of the edible succulent Caralluma fimbriata, which is from the same family as hoodia gordonii. It works by reducing the formation of new fat cells and by inhibiting the maturation of pre-adipocytes into adipocytes. It also affects satiety, claimed Venkatesh. "We have done two human clinical studies. The first was in India. It was a double blind, randomised, placebo-controlled 50-patient study for eight weeks designed to study its appetite suppression properties, which were statistically significant and showed a significant trend in comparison to placebo.
"We then carried out a follow-up study on 26 patients in Los Angeles." Obese and overweight volunteers typically lost weight, while normal-weight volunteers lost inches off their hips and waist, he said.
Slimaluma, which obtained GRAS (generally recognised as safe) status in the US last year, was also the subject of full cell line studies into its effects on a range of factors, including adipocyte differentiation, fat accumulation and leptin, he said. Further work was now progressing in areas related to hormones and genes and to fat loss, satiety and metabolic syndrome, he added.
From a technical point of view, the extract can withstand high temperatures and is about 98% water soluble, said Venkatesh.
"We are working on further developing the solubilisation characteristics to ensure ideal qualities for beverage applications." More land was also being devoted to Caralluma cultivation, he said.
Caralluma fimbriata was shaping up to be one of the most exciting ingredients in the weight management market, said Dr Paul Clayton, who chairs the food group at the Royal Society of Medicine. "I am very impressed by the taxonomic work that has been done on this herb which, combined with preliminary clinical studies, was enough to convince me, and I am very sceptical about this whole area."
Clayton, who was speaking at a recent seminar on weight management hosted by the Food and Drink Innovation Network, added: "A lot of work has been done on Caralluma's mode of action on adipocytes, and it is impressive stuff; there is now a detailed understanding of how it switches the fat cells off at the level of cell cycle inhibition."
By contrast, the evidence underpinning many other ingredients in the market was "remarkably unconvincing", he said. Known as a famine food in India, where it is cooked as a vegetable, used in chutneys and pickles, and eaten raw, Caralluma fimbriata is from the Asclepiadaceae family.