Posted 21 October 2011
Readers may remember that I recently voiced my disbelief that Alison Viennings had tried to substantiate a Clicks Hoodia product. In previous postings I have pointed out that Unilever had cancelled a 20 Million Euro project after finding that hoodia made no contribution to appetite suppression, weight-loss and that side effects were unacceptably high. Now the research that made Unilever decide to can the project has been published.
Note, all hoodia products on the South African market use between 250 to 500mg once, twice or three times a day. Most that I tested had very low to absent levels of P57 in contrast with the research where the P57 was assured.
The randomised, double-blind, placebo-controlled, parallel-group trial was conducted with about 25 healthy, 18-50 year old women in each of the hoodia and placebo groups. During the 15-day trial period they were given either two servings per day of 1110mg of hoodia extract in a yoghurt extract an hour before breakfast and dinner or placebo.
Why Unilever canned €20m hoodia project: Newly published study disappoints
By Shane Starling, 18-Oct-2011
Part of the reasoning for Unilever’s controversial 2008 decision to sever a €20m partnership with UK firm Phytopharm to develop the weight management plant hoodia gordonii has become apparent, with disappointing trial results published this month.
Research published in the American Journal of Clinical Nutrition found hoodia was no better than placebo for affecting energy intakes or body weight in a 15 day trial among healthy, overweight women.
A Unilever spokesperson told NutraIngredients it had known the outcome of the research at the time it pulled out of the hoodia deal, which it justified at the time on doubts over both safety and efficacy.
“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,” the spokesperson said.
“This research has now been published in the American Journal of Clinical Nutrition.”
Hoodia gordonii is a small cactus that grows in the Kalahari desert and has a history of use among local people as a promoter of satiety.
Phytopharm gained a global license to market it in 1997 but late last year returned patents for extracts from the plant to the South African government.
The randomised, double-blind, placebo-controlled, parallel-group trial was conducted with about 25 healthy, 18-50 year old women in each of the hoodia and placebo groups.
During the 15-day trial period they were given either two servings per day of 1110mg of hoodia extract in a yoghurt extract an hour before breakfast and dinner or placebo. They were allowed to eat normally otherwise.
As well as there being no weight management benefit in the target group, some adverse reactions were noted.
Hoodia, the researchers observed, “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.”
They concluded: “There are many commercially available dietary supplements that claim to contain H. gordonii. Given the results here, we cannot exclude the possibility that consumers who take certain of these supplements could experience similar side effects.”
“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.”
Am J Clin Nutr. 2011 Oct 12. [Epub ahead of print]
Effects of 15-d repeated consumption of Hoodia gordonii purified extract on safety, ad libitum energy intake, and body weight in healthy, overweight women: a randomized controlled trial.
Blom WA, Abrahamse SL, Bradford R, Duchateau GS, Theis W, Orsi A, Ward CL, Mela DJ.
From Unilever Research & Development, Vlaardingen, Netherlands.
Extracts from Hoodia gordonii have been shown to decrease food intakes and body weights in animals and were proposed as a food supplement or ingredient for weight management.
We assessed the safety and efficacy of a 15-d repeated consumption of H. gordonii purified extract (HgPE) relative to a placebo in humans.
Healthy, overweight women, who were stratified by percentage body fat, received either HgPE (n = 25) or a placebo (n = 24) for 15 d. Subjects were resident in a clinic for a 4-d run-in period and a 15-d treatment period in which they received 2 servings/d of 1110 mg HgPE or a placebo formulated in a yogurt drink 1 h before breakfast and dinner. Subjects were otherwise allowed to eat ad libitum from standardized menus.
There were no serious adverse events, but HgPE 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 (P < 0.05) increases in the HgPE group. Mean effects on ad libitum energy intakes and body weights did not differ significantly between the HgPE- and placebo-treatment groups (P > 0.05).
In comparison with a matched placebo, the consumption of HgPE for 15 d appeared to be associated with significant adverse changes in some vital signs and laboratory parameters. HgPE was less well tolerated than was the placebo and did not show any significant effects on energy intakes or body weights relative to the placebo. This trial was registered at clinicaltrials.gov as NCT01306422.
PMID: 21993434 [PubMed – as supplied by publisher]
The full pdf is available here: http://www.ajcn.org/content/early/2011/10/12/ajcn.111.020321.full.pdf