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Certifications for Slimaluma

 

Slimaluma® has attained the following certifications:

Self Affirmed GRAS Status: Slimaluma® was affirmed GRAS in June 2006. This followed a thorough and intense review of the safety and toxicology data of Slimaluma® by an expert panel. The expert panel have certified Slimaluma® as Generally Recognized As Safe, paving the way for the product’s usage in foods.

Kosher and Halal Status: The manufacturing facility producing Slimaluma® has been certified Kosher by Star-K Kosher. The facility has also been certified Halal by IFANCA.

Organic Status: The farm in which the herb is cultivated as well as the manufacturing facility where the extraction is done have both been certified Organic according to USDA and EEC regulations. The inspection and certification was done by Control Union Certifications, Zwolle, Netherlands.

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Independent Clinical Trials

 

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® taken one hour before a 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.

Boody 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 a 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 from 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.

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Safety Studies

 

Acute Toxicity Study at St John’s National Academy of Health Sciences, India

An acute toxicity study on Wistar rats was done, under OECD guidelines, using a very high dose of 5g per kg body weight. No mortality or toxicity was observed.

No mortality was observed following the administration at a very high dose of 5g/kg body weight. Body weight, feed and water intake in all the rats were comparable with that of the control.

Subchronic Oral Toxicity Study at Bombay College of Pharmacy, India

A Subchronic Toxicity Study was done in Wistar Rats, under OECD guidelines, at 90 mg per kg bodyweight, which is equivalent to the recommended human dosage of 1 gram a day. No mortality or toxicity was observed.

Mutagenicity Study [ Ames Test ] at Intox Pvt. Ltd., India

Mutagenicity Study by Salmonella Typhimurium reverse mutation test was carried out as per the OECD guidelines. It was concluded that the product was non-Mutagenic in all the 5 strains of Salmonella Typhimurium.

The Toxicity studies on Slimaluma® were presented at the 2006 Annual Meeting and Exposition of the American Association of Pharmaceutical Chemists in San Antonio, Texas, USA, held from 29th October to 2nd November 2006.

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