The South African San Council (SASC) last week released a statement that said inaccurate data about levels of P57 – which some research suggests is the primary satiety-delivering glyceride of hoodia – were partly to blame for Unilever’s 2008 decision. Media reporting of the trial was also unbalanced, it said.
The statement comes as the country’s Council for Scientific and Industrial Research (CSIR) publishes a summary of 14 clinical trials conducted between 1999 and 2003 – where mostly supplements rather than liquids were studied – that showed the cactus extracts were, “generally safe and well tolerated”.
“Commercialisation of Hoodia gordonii as a dietary supplement has created major interest around the world and further development of hoodia as a functional food for management of weight remains important,” said CSIR technology manager, Dr Vinesh Maharaj.
Dr Maharaj told NutraIngredients that CSIR, which recently re-acquired IP around the extract from former holder, UK start-up, Phytopharm, was actively seeking licensing partners.
“The development going forward requires clinical studies which are typically multi-million rand investments. The clinical studies have not been scoped yet, so no precise budgets are available at this stage,” he said.
“The CSIR does not have a budget for further development [but] will engage with all stakeholders, public funding institutions and potential licensees to support further development.”
A summary of the 14 trials, which include those conducted by Phytopharm and original license holder, Pfizer, can be found here.
P57 levels
SASC said some of the initial information around the 2008 Unilever trial that ultimately led to its withdrawal did not specify P57 quantities, rather generalising that glyceride content was about 80%. There are more than 20 glycerides in hoodia.
“That is what was claimed by the CSIR and what fuelled the commerciality of hoodia in the first place,” SASC said. “If the actives are not quantified nor standardised and ensured throughout the trial, the outcomes are fatally flawed.”
It said heat treatment and the liquid application form employed in the trial contributed to a lower level of P57 than may have otherwise been present.
“It was confirmed that P57 was not stable in a liquid suspension and that the entire active compound settled to the bottom of the liquid medium,” SASC said.
Flawed?
Chairman Andries Steenkamp added that the double blind, placebo-controlled study conducted in 2008 and published this year in the American Journal of Clinical Nutrition, was flawed.
“It was not a cross over study and therefore no comments on clinical reverence or relevance to things like blood pressure should be made as there is no cross over comparison data,” he said.
But a Unilever spokesperson reiterated its earlier position in stating: "Unilever terminated its hoodia gordonii project in 2008 after clinical research found that using hoodia gordonii extract in a Unilever-branded product would not meet our high standards for safety and efficacy. This research has now been published in the AJCN."
The researchers in question noted hoodia, “was less well tolerated than was the placebo because of episodes of nausea, emesis, and disturbances of skin sensation. Blood pressure, pulse, heart rate, bilirubin, and alkaline phosphatase showed significant increases in the [hoodia] group.”
But they added: “More knowledge of the mechanisms, sites of action, and active components of [hoodia] is required before a final conclusion can be drawn regarding the potential use of [hoodia] as a viable-candidate functional food ingredient targeted at aiding weight management.”