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Take a look at the patent ---->   http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,612,111.PN.&OS=PN/7,612,111&RS=PN/7,612,111



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Here's the Clinical Study on dogs with arthritis :


The effect of a esterified fatty acids for improving the quality of life of canines was studied. This study investigated whether esterified fatty acids (EFA) could improve the quality of life (QOL) in arthritic canines. Small and large breed dogs were enlisted in the study regardless of current arthritic medication.

Animals were recruited from a veterinary practice in a suburb of San Diego, Calif. The vet clinic had a sizeable number of canines currently under care for the treatment of joint health disease. The owners read and signed an informed consent. The study was conducted using animal care guidelines for veterinary practices.

The owners were instructed to bring the dog in for an assessment by the veterinarian. Upon enrollment, the owner completed a medical history and general Quality of Life (QOL) survey. During this time the veterinarian gave the pet a physical exam of major body areas and joint structures, which is standard for musculoskeletal disease assessment. Blood and urine were collected with each visit. The dog was given a 30-day supply of EFA product. The owners were also told to take their dogs on daily walks lasting from 10 to 20 minutes. The animals were maintained on their current medication regimen. The owner then returned with the pet after 30 days for the final physical assessment by the veterinarian and to fill out the QOL survey again.

Esterified Fatty Acid Product

The animal was given dog chews containing a mixture of EFA, dextrates, desiccated liver and hickory flavor. A standard dose of two chews per day per 20 pounds was established.

Quality of Life Survey and Analysis

The survey was filled out at the initial visit and again after 30 days of supplementation. The owners were asked to write their answers next to the questions.

Clinical Measures

These measures were taken at the initial visit and again after 30 days of supplementation. Each dog had blood drawn from the jugular vein with a 22-gauge needle attached to a 6 cc syringe. This is standard practice to minimize any pain and anxiety the animal might experience in having it's blood drawn. Experienced, licensed registered veterinary technicians drew the blood. The blood was placed in a lavender top tube and a serum separator tube. The blood in the serum separator tube was allowed to clot (10 minutes) then spun in a centrifuge. Both tubes were placed in the clinical reference laboratory bag (IDEXX Veterinary Services, Inc. Atlanta, Ga.). The appropriate forms were filled out and then the entire bag was placed in the refrigerator for transport to the clinical reference laboratory. A standard chemistry 27 panel was obtained plus a comprehensive CBC.

Urine was obtained by using an ultrasound probe to locate the bladder then by performing ultrasound-guided cystocentesis or by walking the dog and collecting a "free catch" sample into a sterile collection container. The urine obtained by either method was placed into a red top tube (no serum separator gel was used) and placed in the IDEXX bag for collection. The appropriate forms were filled out for the laboratory and placed in the bag with the urine and the blood. Standard urine biomarkers were obtained for each collection.

Clinical Analysis

Clinical chemistry tests were performed on Hitachi 747 200.RTM. chemistry auto-analyzers using wet reagents. After calibration, normal and abnormal controls were run before each testing sequence, after every 50 specimens, and again, after each run sequence to ensure calibration stability. Quality commercial reagents used were standard to the equipment.

Hematology tests were performed on Abbott Cell-Dyne.RTM. 3500 auto-analyzers using the laser flow cytometry methodology. Hematology results were verified by several different means including commercial controls, patient controls, pre-assayed standard calibration samples, machine-to-machine comparisons and inter-laboratory comparisons and controls run on every shift.

A total of 27 animals were enrolled in the study, 24 animals completed the study. There were two animals dropped from the study due to noncompliance. One animal was euthanized due to complications unrelated to the study protocol. Average demographics of the dogs were as follows: Age (yrs)=10.5.+-.2.0; Weight (lbs)=70.4.+-.25.0; and Gender (male/female)=13/11. The average length of time on the study product was 32.8.+-.5.7 days.

There were no changes in serum or urine biomarkers after the 30 day supplementation period. There were a few animals that had some modest improvement in their gait, but over the clinical evaluation did not uncover any noticeable improvements.

The owners' responses to the questionnaire provided some enlightening information. Owner comments for the QOL survey were very favorable. Each owner was also asked to write in their own words what they felt was achieved with the dietary intervention. There was a consistent pattern among participants for improved vitality and function.

The present study demonstrated the benefit of using an EFA supplement as an intervention in the treatment of canines with musculoskeletal conditions. The animals exhibited typical signs and symptoms of degenerative joint disease or osteoarthritis. It is worth noting that many animals were currently on a standard prescription for treating their malady but were still able to experience improvement. The present study investigated the use of esterified fatty acids for improving QOL in canines of various breeds. The pet owners felt that their animals had improved mobility and energy compared to their observations prior to the intervention. While clinical examination did not reveal any noticeable differences, it is not uncommon for dogs to "stiffen" when being evaluated. This serves as a protective mechanism when confronted in unfamiliar environments.

In summary, esterified fatty acids improved the general disposition and functional ability in dogs suffering from arthritis. These fatty acids offer an alternative to more traditional therapies for treating arthritis in canines.



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No placebo control, or control group of any kind, anecdotal subjective measure of efficacy from owners, not even single blinded on the human side. Garbage science.

Jere

Jere

This was a Clinical Trial to satisfy patent requirements.
There are never placebo controls or single / double blinds in this kind of study.
This kind of study is to show if the product does what it says and whether it's
production and efficacy is patentable.



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Posted By Doc_E on 15 Jun 2010 09:24 PM
Jere

This was a Clinical Trial to satisfy patent requirements.
There are never placebo controls or single / double blinds in this kind of study.
This kind of study is to show if the product does what it says and whether it's
production and efficacy is patentable.



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If the patent office accepts this sort of @&)$ ....

It failed to establish efficacy miserably. Didn't prove anything but the urine and blood work were unchanged by the treatment - could actually have been abnormal, indicative of problems and the indications persisted with the "supplement."

Additionally, the tests performed appear to be general tests -"A standard chemistry 27 panel was obtained plus a comprehensive CBC.

"Standard urine biomarkers were obtained for each collection."

rather than tests for factors more specific to the disease process purportedly being treated.

"There were no changes in serum or urine biomarkers after the 30 day supplementation period."

The owners "performed" the rest of the assessments and the conclusion: "The present study demonstrated the benefit of using an EFA supplement as an intervention in the treatment of canines with musculoskeletal conditions." essentially hinges entirely on those assessments. Their expectations would be expected to influence their assessments - that's why essentially all such testing in humans is double blinded and placebo controlled.

The above implication of benefit is w/o any justification. There was no apparent "benefit."

About all that might be said is the supplement didn't change the blood and urine assay results - for better or for worse. Maybe the stuff is safe, but then again, maybe it is not. It is not effective - per this trial.

Jere