Cetylated fatty acid and alkali buffered creatine anti-inflammatory composition

Abstract

An anti-inflammatory composition for treatment of inflamed joints. This composition includes an alkali buffered creatine and a cetylated fatty acid. The composition can be used for treating inflammation either by oral ingestion or by topical treatment.

Claims

1. A method of treating either or both of joint inflammation and muscle inflammation in a patient, comprising orally administering to the patient having either or both of joint inflammation and muscle inflammation a therapeutically effective amount of a composition consisting essentially of an alkali buffered creatine and a cetylated fatty acid.

2. The method of claim 1 wherein the cetylated fatty acid is selected from the group consisting of cetyl myristoleate, cetyl mylistate, cetyl palmitoleate, cetyl laureate, cetyl palmitate, cetyl oleate and mixtures thereof.

3. The method of claim 1 wherein the cetylated fatty acid is cetyl myristoleate.

4. The method of claim 1 wherein the patient has joint inflammation.

5. The method of claim 1 wherein the patient has muscle inflammation.

Description

DESCRIPTION OF A PREFERRED EMBODIMENT

(1) The present invention relates to an oral, alkali buffered creatine and cetylated fatty acid composition for reducing joint and muscle inflammation. When taken orally, the fatty acids bonded with the creatine get into the bloodstream and are delivered to the inflamed joint. The cell lipid structure surrounding the joint are lubricated by the fatty acids allowing the creatine to work more effectively in reducing inflammation.

(2) A preferred embodiment of the present invention utilizes an alkalyn buffered creatine sold under the trade name Kre-Alkalyn by All American Pharmaceutical and Natural Foods Corporation. This creatine is then mixed, bonded, reacted or compounded with a cetylated fatty acid as follows:

(3) Typical Formulation:

(4) Formulation 1:

(5) TABLE-US-00001 Kre-Alkalyn7 creatine 500 mg Soy Bean Oil 250 mg Cetyl Myristoleate 250 mg

(6) The Kre-Alkalyn creatine is an alkalyn buffered creatine. The soybean oil is a fatty acid and is used as a base. The cetyl myristoleate is a member of the cetylated fatty acid family.

(7) Clinical tests were performed to determine the efficacy of this formulation.

(8) Clinical Tests:

(9) Objectives: Determine if a unique oral, alkali buffered-creatine B cetylated fatty acid composition (Kre-1), (a) is capable of reduce chronic joint and muscle related inflammation/pain, (b) can address site-specific pain with equal effectiveness, and, (c) will increase range of motion (ROM) in the afflicted area.
Design: A total of 35 subjects (21 males, 14 females), each experiencing isolated areas of joint/muscle inflammation/pain, were divided into 2 groups: Group A was assigned four capsules of Kre-1 daily, Group B, an equal number of placebo capsules. The duration of the study was 30 days.
Settings/Location: Participants entrance and exit interviews were conducted in the conference center at the All American Pharmaceutical. Study information (informed consent, test and placebo materials) was provided by an administrative assistant at All American Pharmaceutical. Pre and post blood tests (creatinine, AST, C-reactive protein) were accomplished at a local Laboratory Corporation of America blood lab. Physical examinations (entrance and exit), blood pressures, ROM, target area tenderness assessments, scoring and review of personal >Pain Journals=by the test subjects and physicians were conducted at the Yellowstone Naturopathic Clinic, in Billings, Mont.
Subjects: Group A (n=24; age 55 +/32 yrs.) received Kre-1, and >Group B=(n=11; age 45 +/15 yrs.) received the placebo.
Results: Data indicated approximately: 100% of ankle and foot pain, 80-85% of neck, shoulder, elbow, wrist, and hand pain, 71% of knee pain, respondents rated Kre-1 better than/as good as a prescription product in its ability to reduce/eliminate pain. Hip and back pain scores were no better than placebo scores for the same areas. >Group A=experienced a modest increase in mobility (35%), but no measurable increase in ROM over that experienced in the placebo group (Group B).
Conclusions: Kre-1 exerts it greatest impact on areas of inflammation/pain in the extremities, as well as in the neck and shoulder region.

(10) TABLE-US-00002 TABLE 1 Oral Kre-1 for Joint and Muscle Inflammation B Study Data Group A (Kre-1) Group B (Placebo) Participants: Initial 24 11 Completing 20 (21)* 11 Gender 17 males/3 females 4 males/7 females Age 23 B 88 years Drop outs (M/F) 3 F 0 Overall average Entrance blood tests: creatinine 0.9 mg/dl 0.8 mg/dl 23 IU/L AST(SGOT) 4.1 mg/dl 6.2 mg/dl 22 IU/L C-reactive Protein Exit blood tests: creatinine 0.9 mg/dl 0.8 mg/dl AST(SGOT) 25 IU/L 21 IU/L C-reactive Protein 4.2 mg/L 5.1 mg/L Per Area: Pain Relief: Percentage of participants rating Ankle/Foot B 100% (2/2) 0% their treatment, as good as or Knee (and leg) B 71+% (5/7) 0% better than their usual OTC or Hip B 33% (1/3) 33% (1/3) prescription pain reliever Back B 50% (5/10) 0% Neck/Shoulders B 85+% (6/7) 33% (1/3) Elbow/Wrist/Hand 80% (4/5) 33% (1/3) No Pain Relief: Percentage of participants rating Ankle/Foot B 0% 100% (3/3) their treatment, not as good as or Knee (and leg) B 29% (2/7) 100% (5/11) didn't work compared to their Hip B 67% (2/3) 66% (2/3) usual OTC or prescription pain Back B 50% (5/10) 100% (1/1) reliever Neck/Shoulders B 15% (1/7) 66% (2/3) Elbow/Wrist/Hand 20% (1/5) 66% (2/3) Overall Average Yes No Yes No Personally said they experienced 60% 40% 27% 73% reduced pain/increased mobility (12/20) (8/20) (3/11) (8/11) Overall Average Blood Pressure: Entrance Systolic/Diastolic 127/83 129/82 Exit Systolic/Diastolic 125/75 119/77 *This participant withdrew before the end of the study.

(11) TABLE-US-00003 TABLE 2 Kre-1 for Joint and Muscle Inflammation B Physicians Reports Group A (Kre-1) Group B (Placebo) Pain: Decrease 90% (18/20) 36% (4/11) No Change 10% (2/20) 55% (6/11)

(12) The results of this study show that a combination of a cetylated fatty acid and an alkalai buffered creatine provides an effective non-prescription material for reduction of pain and stiffness of the extremities, neck and shoulder regions in humans. It is intended that members of the cetylated fatty acid family including cetyl myristoleate, cetyl mylistate, cetyl palmitoleate, cetyl laureate, cetyl palmitate and cetyl oleate could be used equally as well. The cetylated fatty acids have anti-inflammatory properties with the ability to suppress pro-inflammatory cytokines. The alkali buffered creatine positively affects endothelial permeability, thereby inhibiting potentially inflammatory stimulating molecules from adhering and expressing their action as endothelial cells.

(13) Delivery of the creatine/fatty acid composition may preferably occur through ingestion. It is contemplated that the creatine/fatty acid composition may be formulated such as a liquid drink and allow for oral ingestion. Further, the creatine/fatty acid composition may be formulated including solid formulations such as granules, a tablet, a capsule and the like for oral ingestion. Further, a food supplement such as a sports bar, and the like, may be employed for delivery of the creatine/fatty acid composition.

(14) In addition, other formulations such as an emulsion, suspension and the like may be employed and allow delivery of the creatine/fatty acid composition to an inflamed joint. These formulations allow application through a variety of methods such as topical applications including ointments, lotions, creams and gels.

(15) While the fundamental novel features of the invention have been shown and described, it should be understood that various substitutions, modifications, and variations may be made by those skilled in the arts, without departing from the spirit or scope of the invention. Accordingly, all such modifications or variations are included in the scope of the invention as defined by the following claims: