An independent neurologist assessed 4 of the subjects who reported disturbances in skin sensation. In the absence of neurologic abnormalities and given the transitory nature of symptoms, these symptoms were deemed most likely to be a study-product effect.
When the study was unblinded, all of these subjects were shown to be in the Hg PE group. Summary of AEs 1. All values are the number of incidences; number of distinct subjects in parentheses.
All electrocardiograms were determined by the investigator to be either normal or abnormal but not clinically significant. The dosing period is shaded. Hg PE, Hoodia gordonii purified extract. This elevation was not noted in the placebo group. Energy intake values are shown in Figure 4. In both the Hg PE and placebo group, a marked decline in the mean energy intake was apparent by study days 3—5. This reduced intake was maintained for the duration of the treatment period in both groups and was seen at all meal occasions.
The same menus were provided on the 4 clusters of 3 d. Statistical analyses were performed in 21 subjects who were randomly assigned to the placebo group and in 19 subjects who were randomly assigned to the Hg PE group.
The mean body weight at the end of treatment, which was corrected for baseline, did not differ significantly between the placebo or Hg PE groups absolute difference: 0. During the follow-up period, mean body weights returned to baseline baseline for placebo: The d repeated intake of Hg PE or placebo had no significant effect on percentage body fat; values for the placebo and Hg PE groups were Therefore, weight loss was equally distributed over fat mass and lean body mass.
Pharmacokinetic parameters calculated for the H. Pharmacokinetic parameters of H. Compartmental modeling was used. The model explained 9. The model explained This study showed that repeated the consumption of Hg PE over a d period under highly controlled conditions had no significant effects on ad libitum energy intake, body weight, or percentage body fat in healthy overweight women relative to the consumption of a matched placebo.
There were no serious AEs, but Hg PE was less well tolerated than the placebo and produced adverse changes in some clinical measures. The clinical significance of changes in bilirubin and ALP was unclear because subjects had no other elevations in liver enzymes or evidence of hemolysis. However, the trend for bilirubin values to increase over time in the Hg PE group, which returned to normal after treatment was finished, was similar to the finding in a previous human study with a pharmaceutical grade extract J Richards and R Grover, unpublished observations, It is also known that bilirubin increase can be associated with prolonged fasting 18 — 20 ; however, no corresponding change in bilirubin was seen in the placebo group despite a similarly reduced food intake.
Therefore, it seems probable that this effect on bilirubin was a direct effect of the Hg PE, but this possibility needs further investigation. It is clear that the Hg PE group had a much higher incidence of TEAEs and a higher number of withdrawals compared with those in the placebo group, despite similar weight loss for both groups. These results suggested that AEs reported in the Hg PE group could be only partly explained by weight loss.
Furthermore, a neurological assessment of reported disturbances in skin sensation indicated that these were most likely a study-product effect, and all affected subjects were in the Hg PE group. Although Hg PE induced a number of physiologically relevant changes in this study, its effects on energy intake and body weight did not differ from those with the placebo. The actual statistical power was much greater than anticipated because the SD of the treatment difference in energy intake was smaller than expected.
Therefore, the lack of significant differences in energy intakes was not due to a lack of power but reflected the small effect size. Overweight subjects have previously been shown to exhibit a tendency to decrease their energy intakes below requirements under restricted conditions such as those experienced in this study 21 , Therefore, it is plausible that subjects were intentionally dieting during the d treatment, even though the screening for dietary restraint and dieting had been intended to exclude subjects highly concerned about their weight or prone to dieting.
Given the reduction in energy intake also seen in the placebo group, the efficacy in the Hg PE group might have been more readily demonstrable if subjects experienced less feelings of hunger at this same amount of caloric deprivation. However, the analysis of self-reported hunger and satiety data data not shown also did not indicate any treatment differences over the course of the trial. Another potential factor could have been the knowledge by subjects that their food intakes and body weights were being measured, which led to the conscious or unconscious inhibition of food consumption and resulted in weight loss.
Undereating can also be induced by meals being too low in energy content or energy density 23 ; however, the energy densities of food products in the current study were within normal ranges. The average total energy density for meals and test products eaten in this study at baseline was 1. A typical reported total diet energy density, excluding beverages, in subjects who were studied outside of a residential environment was 1. Any effect of low energy density on energy intakes would also have been expected to be most apparent in the immediate run-in period, but this effect was not seen.
Subjects with low acceptance of the foods provided were excluded from participation; therefore, it was unlikely that the foods were unacceptable or unpalatable to the volunteers. However, the repetition of meals and the lack of variability in types of meals may have induced some degree of boredom or sensory specific satiety and reduced the liking or wanting of meals as the study proceeded Several of the AEs reported by subjects in this study, such as dizziness, giddiness, nausea, and vomiting, could also have reduced appetite and, therefore, reduced energy intake.
However, these AEs were predominantly reported by the Hg PE group, and incidences of nausea and vomiting were not clearly linked with changes in energy intakes. The maximum average concentration of the H. Because of the rapid absorption and elimination characteristics of H. However, without a more complete understanding of the mechanism and site of action, it is difficult to define whether plasma C max or exposure is more important. Despite this, there was no clear correlation between the H.
Furthermore, given the observed AEs and changes in clinical measures at the current dose amount, the tolerability and safety of higher intakes or other patterns of consumption would need to be carefully considered. In conclusion, the totality of data from this study did not provide evidence of efficacy in terms of a reduction in energy intakes and body weights in the Hg PE treatment group relative to in the placebo-treatment group. There were no differences in effects at different meal occasions eg, at breakfast or dinner and no consistent relations between markers of Hoodia exposure ie, C max and AUC and reductions in energy intake.
Hg PE was less well tolerated than the placebo and significantly affected some clinical and safety parameters, such as blood pressure, bilirubin, and electrocardiogram measures. There are many commercially available dietary supplements that claim to contain H. 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 Hg PE is required before a final conclusion can be drawn regarding the potential use of Hg PE as a viable-candidate functional food ingredient targeted at aiding weight management.
We thank the volunteers who participated in the study, staff at Covance Clinical Research Unit in Madison who performed the study, Nancy Sills and Stacie Aragon, and all Covance staff who assisted in the organization and reporting of the study, and Barbara Rolls and Jennifer Meengs, The Pennsylvania State University, for their assistance in development of the meal plan. CLW is employed by Phytopharm plc, which was the co-sponsor of this study, and AO is former head of research and development at Phytopharm plc.
At the time of this study, Phytopharm plc held a worldwide license for the application of H. None of the authors had a conflict of interest.
Bruyns P. Stapeliads of Southern Africa and Madagascar. Hatfield, South Africa : Umdaus Press , Even though many companies are making significant profits off of hoodia product sales, it has not been approved by the Food and Drug Administration. Since it is sold as a dietary supplement, FDA approval is not required to sell the product in the United States.
Use the following guide to learn about the dangers of this miracle weight loss drug as well as the differenet types of hoodia that are available.
What is Hoodia Gordonii? Hoodia is a stem succulent, somewhat like a cactus, grown in South African desert regions. The San use hoodia for a variety of medicinal purposes, but most often, they chew it to avoid getting hungry and thirsty during extended hunting trips.
There are twenty different species of hoodia, but only hoodia gordonii appears to have the active ingredient p57, which provides the effects of an appetite suppressant. The South African government gained a patent for p57 and licensed it to a pharmaceutical company, Phytopharm. Later, it was determined that hoodia was not economically feasible for mass production, particularly due to the inability to effectively grow it anywhere except the African desert.
Case Studies. In , there were several case studies that examined the use of hoodia for weight loss and also noted possible negative side affects. David McLean of Brown University conducted one of the studies. He noted that hoodia use seems to have an effect on the part of the brain that controls appetite. However, he only experimented on animals and noted that human results may be different due to different metabolisms. Two small human studies, one with seven participants and one with eighteen, appeared to demonstrate that the volunteers taking hoodia supplements dramatically decreased their caloric intake by as much as half.
Tthe volunteers demonstrated no negative side effects in either study. Other than these minimal studies, there is little U. As your metabolism strengthens and you crave for less food, you can aim for burning an extra calorie everyday to lose weight at a quicker pace and to get ripped quick. Hoodia Gordonii pill manufacturers often claim Hoodia weight loss pills to have no side effects. Although the San Busmen of Kalahari desert of Africa have been known to use it for thousands of years, its popularity in North America and Europe rose quite late.
However, from user experiences, many health practitioners have shown serious concerns about the usage of Hoodia Gordooni. It is known to show some side effects on the liver caused by components of Hoodia. Therefore, as it effects the liver, it also has potential to react with other medications thus resulting in some unpleasant repercussions. People with diabetes should be warned against using Hoodia weight loss pills.
This can result in drop in blood sugar level. Besides that, Hoodia also suppresses thirst. So, if you have started taking Hoodia weight loss pills, you might suffer dehydration without noticing it. Harvey Anderson, a professor of nutrition at the University of Toronto, applauded the new report in an email to Reuters Health. Things did start out great for the herbal extract, which comes from the succulent plant Hoodia gordonii and has purportedly been used for millennia by Bushmen in the Kalahari trying to ward off hunger on long hunting trips.
Lab tests showed it made rats eat less, and an unpublished study suggested the same was true for humans, according to the new report. Phytopharm then struck a deal with the U.
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