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Review Article
Recent update in management of obesity and Overweight Patients: Standardized
extract of Caralluma Fimbriata safe and effective Therapy.
Bansi Saboo, Dia care, Ahmedabad, India
Hemant Zaveri, Medical Advisor Zydus Nutriva Ahmedabad, India
International Journal of Clinical Cases and Investigations 2011. Volume 2 (Issue
1), 5:9, 6th
February 2011
Abstract
Obesity is associated with many diseases, particularly diabetes, hypertension, osteoarthritis,
and heart disease. The obesity incidence has increased at an alarming rate in recent years,
becoming a worldwide health problem, with incalculable social costs. Two different obesity-
treatment drugs were present on the market: orlistat, which reduces intestinal fat
absorption via inhibiting pancreatic lipase; and sibutramine (Withdrawn worldwide), an
anorectic or appetite suppressant. Both drugs have hazardous side-effects, including
increased blood pressure, dry mouth, constipation, headache, and insomnia. For this
reason, a wide variety of natural materials have been explored for their obesity treatment
potential. This review aimed to survey the literature covering nutraceutical product with
anti-obesity activity and to review the scientific data, including experimental methodologies,
active components, and mechanisms of action against obesity.
Introduction
Obesity is a major global health problem and a risk factor for several chronic disorders such
as diabetes, hyperlipidemia, hypertension and cardiovascular disease. Weight gain and
obesity are a result of positive energy balance due to a mismatch between energy intake
(EI) and energy expenditure (EE). The EI in turn is subject to a wide range of influences,
including appetite, gastro-intestinal signals such as distension of the stomach, chemical
signals to the gastric mucosa and blood-borne metabolites such as glucose and fatty acids.
Strategies to reduce a positive energy balance have often focused on increasing EE since it
was thought that the EI of obese individuals was normal or low and additionally, because of
the independent effects of physical activity on the reduction of risk for many chronic
disorders associated with obesity. However, overweight subjects often under-report their
food intake,1, 2
and carefully conducted objective measurements have shown that EI is in
fact increased in obese subjects. 3, 4
The complex process of appetite is controlled by several
neural, humoral and psychological factors,5
and strategies that suppress appetite are likely
to be useful in weight loss and control. Appetite suppressant medications, while effective
often have side effects.6

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The standardized extract of Caralluma Fimbriata, an edible plant used for centuries in India
as a famine food, approved in India, Australia and USA as safe and effective therapy
for management of obesity and overweight patients.
Standardized extract of Caralluma Fimbriata has been extensively studied for its use in
appetite suppression leading to clinically significant weight loss. The effect of standardized
extract of Caralluma Fimbriata was assessed in overweight individuals by a placebo
controlled randomized trial.7
Most importantly, to determine safety, there are no adverse
event reports in the Indian subcontinent over the centuries of use.8
Mechanisms of Action
It is postulated that the pregnane glycosides and perhaps constituents in Standardized
extract of Caralluma Fimbriata prevent fat accumulation via blocking citrate lyase. 9
Because standardized extract of Caralluma Fimbriata is a competitive inhibitor of ATP-citrate
lyase, an extra mitochondrial enzyme involved in the initial 25 steps of de novo lipogenesis.
C. fimbriata also has hydroxycitrate (HCA) as active component. HCA has been reported to
cause weight loss in humans without stimulating the central nervous system.10, 11
Consequently, HCA reduces the transformation of citrate into acetyl coenzyme A, a step
necessary for the formation of fatty acids in the liver.
In addition to its effect on citrate lyase, the postulated blocking of malonyl coenzyme A by
Standardized extract of Caralluma Fimbriata could further lead to a decrease in fat
formation in the metabolic pathway.12
New fat cells are formed as preadipocytes.
Standardized extract of Caralluma Fimbriata inhibit new fat cell formation by acting on
malonyl coenzyme.
Standardized extract of Caralluma Fimbriata inhibits this hunger sensory mechanism of the
hypothalamus. The pregnane glycosides contained in Standardized extract of Caralluma
Fimbriata interfere with the signaling mechanism and create a signal on its own, seeming to
fool the brain into thinking that the stomach is full, even when the person has not eaten
much . More specifically, it is believed that the pregnane glycosides in Standardized extract
of Caralluma Fimbriata inhibit the hunger sensory mechanisms of the hypothalamus. It
could be assumed that the appetite-suppressing activity of C. fimbriata is attributed to the
presence of the aforementioned pregnane glycosides.

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Regarding long term use, clinical studies that support the routine use and safety and
efficacy of standardized extract of Caralluma Fimbriata administration for up to 1 year by us
at our centre, which was specifically designed to assess the safety and efficacy of
standardized extract of Caralluma Fimbriata on maintenance of weight loss, showed that
weight loss achieved with standardized extract of Caralluma Fimbriata can be maintained for
up to 1 years and cause significant changes in high-density lipoprotein cholesterol, very
low-density lipoprotein cholesterol, triglycerides, and uric acid exceeding those expected
from weight loss alone.13
Adverse effects reported during the study were comparable to
those seen with placebo.
Although the long-term effect of standardized extract of Caralluma Fimbriata on obesity-
associated mortality and morbidity has not been clearly established, the potential of
developing coronary heart disease is directly related to the burden of risk factors present:
Modest weight loss can affect this cluster of risk factors and thus may produce health
benefits for certain patients with chronic obesity who are at risk for other diseases. With the
use of risk equations based on the Framingham Heart Study,14
weight reduction defiantly
reduce risk of various co-morbid condition associated with obesity and overweight.
There is evidence that the principles present in the widely consumed Indian food plant C.
fimbriata extract (CFE) suppress appetite, and provide antiobesogenic and metabolic
benefits. The data substantiate CFE's reported anorexigenic effects. CFE treatment also
conferred protection against atherogenesis. CFE possesses antiobesogenic and
antiatherosclerotic properties.15
Safety and Tolerability
There were no serious adverse events reported by the subjects of the study. 7
The observed
adverse events were minor and limited to initial mild symptoms of the gastrointestinal tract
such as abdominal distention, flatulence, constipation and gastritis. Six (24%) of the
subjects from the Standardized extract of Caralluma Fimbriata group and five (20%) of the
subjects from the placebo group experienced these minor adverse effects. These symptoms
were present in both the Standardized extract of Caralluma Fimbriata and placebo group of
subjects. The symptoms subsided within a week in all subjects. 7
The only adverse effects that occurred were in two patients (a husband and wife), one of
whom was on active substance and the other (male) on placebo. They complained of acidity
and a bloating sensation soon after starting the capsules. Both of them stopped taking the
capsules, then started again and claimed they developed the same symptoms. Therefore,
they both discontinued taking the capsules altogether.
In addition to the long history of safe ingestion of the cactus as a food, further evidence of
safety of its extract is evident through an acute oral toxicity study on rats and two clinical
studies. The former was carried out by the Department of Pharmacology, St John's Medical
College in Bangalore, India. Doses of 2g/kg body weight and 5g/kg body weight were
gavaged to rats. All animals survived until the scheduled necropsy at the end of the study
period of 14 days. Histology revealed no abnormalities in the various organs. Accordingly
the LD50 for the rats 14 exceeded 5g/kg.
Conclusion
Both the clinical trials done on standardized extract of Caralluma Fimbriata clearly
demonstrated that there was reduction in hunger levels, reduction in weight, waist circumference,
reduction in fat and reduction in body weight in the active group of participants. The results

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of the various studies suggest that Standardized extract of Caralluma Fimbriata has a
potential appetite suppressing action. This concurs with the anecdotal evidence provided by
tribal populations in India. The effect of appetite suppression translated into a net effect of a
reduction in energy and fat intake and was accompanied by a reduction in intake of less
desirable food groups, while the intake of desirable (healthy) food groups remained
unchanged.
It was hypothesized that standardized extract of Caralluma Fimbriata is capable of
decreasing appetite, prevent deposition of fats and reduce obesity.
This is because Caralluma inhibits fat synthesis by blocking the formation of Acetyl Co-
Enzyme A and Malonyl Co-Enzyme A, which are the building blocks of fat synthesis.
Caralluma also increases burning of fat by the body.
The main reason why most weight-loss programs fail is that the patient always feels dull
and tired after attaining weight loss. This makes the patient go back to his old eating habits
and results in a rebound weight gain. Patients on Standardized extract of Caralluma
Fimbriata however, report feeling more energetic and have gained lean muscle mass, while
losing fat- The reason ‘for this is, that Standardized extract of Caralluma Fimbriata not only
inhibits fat synthesis as mentioned above, it also increases the burning of fat. This makes
more energy available to the body and makes the person more active and lively.
Standardized extract of Caralluma Fimbriata is :
• Clinically tested
• No known side effects
• Standardized extract of Caralluma Fimbriata has undergone several double blind,
randomized, placebo controlled human clinical trials, in India as well as in California,
USA. Many participants experienced significant loss in appetite and some lost inches
off their waist and hips. Participants also experienced reduction in body weight and
body fat.7
• Clinically proven weight loss with significant loss in waist circumference and hip
circumference without changing daily routine
• Standardized extract of Caralluma Fimbriata has been proven safe in toxicology
studies done per exacting OECD guidelines and has achieved self-affirmed GRAS
[Generally Recognized As Safe] status from US FDA.
• Standardized extract of Caralluma Fimbriata has been approve by TGA (Therapeutic
good Administration, Australia)16
• On standardized extract of Caralluma Fimbriata other workers have presented results
of studies at "First World Congress on Therapies Against Obesity" which took place in
Paris in May 2006, under the category of being the latest innovation in the natural
products field in the fight against obesity. Results for trial of Caralluma Fimbriata was
also presented in the 18th International Congress on Nutrition held at Durban, South
Africa in September 2005.
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