Clinical Studies

Two independent clinical trials were done on SLIMALUMA™

1. Clinical Trial at Division of Nutrition, St John’s National Academy of Health Sciences, India.

SLIMALUMA™ underwent a clinical trial at the Division of Nutrition, St John’s National Academy of Health Sciences, Bangalore India during January to August 2003.

This trial was a classical, double-blind, randomized, placebo controlled trial on 62 subjects. The trial was conducted as per OECD guidelines on clinical trials, and in accordance with these guidelines, it was under the supervision of the Ethics Review Board of St John’s Medical College, Bangalore.

Subjects recruited: 62
Dropouts -12
Subjects on placebo – 25
Subjects on active medicine – 25
Duration of the project : January -August 2003
Time points -Visit 1 (initial) Visit 2 (after 1 month) Visit 3(after 2 months)
Dose : One capsule containing 500 mg SLIMALUMA , one hour before major meal.

Results from this clinical trial were subjected to rigorous statistical analysis, using statistical tests are the international norms and approved for double-blind clinical trials. The summary of analysis is presented below.

Statistically significant differences between time points were seen in the active group for the parameters of body weight, body mass index, waist circumference, hip circumference, body fat, blood pressure and hunger levels.

Body Weight :
Active Group : There was a statistically significant decrease in body weight in the active group between all time points.
Placebo Group : Although the weight came down in the placebo group, it was not statistically significant.

Body to Mass Index (BMI) :
Active Group : There was a statistically significant decrease in the body mass index in the active group between all time points.
Placebo Group : There was no statistically significant change in the body mass index for the placebo group.

Waist Circumference :
Active Group : There was a statistically significant decrease in waist circumference in the active group between all time points.
Placebo Group : There was no significant change in the waist circumference for the placebo group between any of the time points.

Hip Circumference :
Active Group : Statistically significant reductions were observed in the hip circumference.
Placebo Group : There was a statistically significant decrease in the hip circumference of the placebo group between visit 1 & 2, while there was no difference between any of the other time points.

Fat Loss :
Active Group : There was a statistically significant decrease in the body fat (expressed in kgs) in the active group of subjects between visit 1 & 2, and visit 1 &3.

Placebo Group : There was no statistically significant change in the body fat of the placebo group between any of the time points.

Hunger Level :
Active Group : There was a statistically significant decrease in the hunger level in the active group.
Placebo Group : There was no statistically significant change in the hunger levels in the placebo group.

Between Group Trends: There was a statistically significant difference in change in hunger levels between the active and placebo group.

Adverse Effects :
Adverse effects noted were gastro-intestinal in nature and were reported by both active and placebo groups. These included acidity (moderate), constipation (mild) and flatulence (mild to moderate).

These effects subsided within a week after commencement. No adverse effects were noted on other systemic functions. No changes in ECG were noted. No sympathomimetic effects were noted. Changes in Basal Metabolic Rate were not investigated.

2. Clinical Trial at Western Geriatric Research Institute, LA, USA.

This trial was done under my supervision on 26 patients and it followed the same double-blind format used in the earlier clinical trial.

Subjects recruited: 26
Dropouts : 2
Subjects on placebo – 7
Subjects on active medicine – 19
Duration of the project : Four weeks
Dose : One capsule containing 500 mg SLIMALUMA™ extract, 30 minutes hour before major meal.

Our subjects were taken from two active practices in the Los Angeles area. The subjects were randomly assigned to either the active group or a placebo group. The trial was carried out on 26 patients, 9 of whom were males. They ranged in age from 31 through 73. One patient nom each category did not show up for the final visit (dropouts).

All patients signed an informed consent.

The substance was administered as one capsule to be taken 30 minutes before each meal. Each subject was weighed (pounds) before and after completion of the study, height was ascertained at each visit, and the waist was measured in inches as well as the hips. The hips were measured at the widest girth while the waist was measured at the umbilicus. In addition, the blood pressure was measured in a standard fashion at the brachial artery in the left upper extremity. From the weight and height measurements, body mass index (BMI) of each subject was ascertained.

This study was continued for four weeks. Patients were instructed not to change their daily activity pattern (exercise), or their food intake. They were told not to change their diet in any way from the preceding four weeks before they began taking the substance.

Summary of Results:

The study was conducted with 26 patients. Nineteen patients were on the active compound and 7 were on placebo. One patient from each category did not show up for the final visit.

Almost every patient taking the active ingredient lost significant weight.

There was almost no weight loss observed in patients on placebo.

Out of 18 patients, 15 patients (83.33%) lost weight. Eleven patients (61.11%) lost about six pounds. The highest loss was nine pounds. Four patients lost one to two pounds, and two patients maintained their starting weight. One patient gained 17 pounds. This patient was found not to comply with the regimen that was requested, and indeed increased caloric consumption over the four weeks.

It is significant that patients with a higher BMI lost more weight.Thirteen out of 18 patients (72.22%) reduced their waist by 0.5 inches to 3 inches.

Five out of 18 patients (27.77%) felt an increase in energy while on the active substance. Three out of six placebo patients (50%) gained one pound and one placebo patients lost one pound.

Adverse Effects
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.

Conclusion
Both the clinical trials done on SLIMALUMA™ clearly demonstrated that there was reduction in hunger levels, reduction in weight circumference, reduction in fat and reduction in body weight in the active group of participants.

SLIMALUMA™ is a clinically proven, safe and non-toxic dietary supplement that can be used for the management of obesity, by appetite suppression leading to clinically significant weight loss.

References :
1. Kuriyan.R., et al. Effect of Caralluma Fimbriata Extract on appetite, food intake and anthropometry in adult Indian men and women. Appetite, (2006), doi:10.1016/ j.appet. 2006.09.013.

2. Ronald.M.Lawrence and Suneeta Choudhary. Caralluma Fimbriata in the Treatment of Obesity. 12th Annual World Congress of Anti-Aging Medicine, December 2004, Las Vegas, USA.

Slimaluma™ In The News…

The Second World Congress for Therapies Against Obesity, Anti-Obesity 2007, took place in the Pasteur Institute in Paris, France, on June 14th and 15th 2007. Gencor Pacific presented new science on Slimaluma at the Congress, showing its activity on an Adipocyte cell line. The study was done by Bharatidasan University, India and the results were presented at the Congress by Dr. M.A. Akbarsha, Dean, School of Life Sciences. 

Cell and molecular level studies have shown that SLIMALUMA inhibits differentiation of pre-adipocytes to adipocytes, thereby reducing formation of new fat cells and reducing formation of new adipose tissue. Further work on serum Leptin levels and MTT assay have validated these results, showing conclusive proof that SLIMALUMA is an excellent fat reducing agent.

These new properties of Fat loss and activity on Leptin levels give a new thrust to SLIMALUMA’s already proven Appetite Suppressing properties, making it a perfect tool for satiety, weight and fat management. The full data of this new research will soon be published in a reputed journal. 

Gencor Pacific are continuing to do more work on SLIMALUMA to validate it’s efficacy, safety and mechanisms of action. “SLIMALUMA will retain it’s unique position in the science and research based ingredients field, as an ingredient with the most comprehensive science behind it ” said Mr. Venkatesh, Managing Director of Gencor Pacific.

Another expert…

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 skeptical 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.

– Reproduced with permission from Food Ingredients, Health and Nutrition, published by William Reed Co., UK

Caralluma fimbriata: A new dietary supplement: Report to the U.S. Food and Drug Administration (PDF)
** Note: Check out page 23-34 for details…

SPECIAL INTRODUCTORY OFFER

For First Time Customers RISK-FREE Introductory Offer - Up to $293.75 in FREE GIFTS and DISCOUNTS!

YES! "Okay, go ahead and Count Me In... I want to put Ultimate GyneMax to work, eliminating my gynecomastia. It's embarrassing, humiliating and I want to experience the kind of dramatic results your case studies are talking about!

Please rush my RISK-FREE supply of Ultimate GyneMax™ as indicated below!

"I understand that I must feel and see the difference Ultimate GyneMax is making to my chest, or I can return the unused bottles for a FULL REFUND. And the FREE Gifts I'm getting are mine to keep.

Buy 3 Bottles and get 2 more FREE months

For just $199.95 - with FREE SHIPPING

I SAVE $149.80 PLUS $14.95 in FREE shipping...

...And I also get the following FREE GIFT:

'Get This Off My Chest NOW' Fast Track System (a $129.00 value)

$293.75 - worth of discounts and FREE gifts in all!

Buy 2 Bottles and get 1 FREE month

For just $169.95 - with FREE SHIPPING

I SAVE $39.90 PLUS $14.95 in FREE shipping...

...And I also get the following FREE GIFT:

'Get This Off My Chest NOW' Fast Track System (a $129.00 value)

$183.85 - worth of discounts and FREE gifts in all!

One 30-Day Supply of Ultimate GyneMax™

Ultimate GyneMax is GUARANTEED to help you lose your chest fat, or your money back!

 

For just $69.95, plus $7.95 shipping and handling.

...And I also get the following FREE GIFT:

'Get This Off My Chest NOW' Fast Track System (a $129.00 value)

$129.00 - worth of discounts and FREE gifts in all!