Composition for promoting joint health

Abstract

A composition comprising proteoglycans and phosphatidylserine, which provides improved joint health, including fast relief for joint pain and increase in endurance / mobility levels while exercising or walking. Methods of providing joint health relief and improved mobility / endurance comprise administering the composition to a human subject. In some embodiments, the composition is a nutritional supplement.

Description

[0001] COMPOSITION FOR PROMOTING JOINT HEALTH

[0002] PRIORITY CLAIM

[0003] This application claims the benefit of the filing date of United States Provisional Patent Application Serial Number 63 / 619,808, filed January 11, 2024 for “COMPOSITION FOR PROMOTING JOINT HEALTH” which is incorporated herein in its entirety.

[0004] TECHNICAL FIELD

[0005] The present invention relates to a nutritional supplement composition comprising proteoglycans and phosphatidylserine that can be administered to a mamalian subject to provide relief for joint pain and increase endurance / mobility levels while exercising or walking. The nutritional supplement can be administered in an oral form or as a topical agent to provide improvements to joint health, increased endurance and mobility, and relief of joint pain.

[0006] DESCRIPTION OF THE ART

[0007] Joint pain can be caused by many types of injuries or conditions. Causes of joint pain include, but are not limited to, autoimmune diseases (such as rheumatoid arthritis and lupus), bursitis, chondromalacia patellae, crystals in the joint (such as, gout and CPPD arthritis (pseudogout)), infections caused by a virus, injury (e.g., a fracture), osteoarthritis, osteomyelitis, septic arthritis, tendinitis, exercise, walking and unusual exertion or overuse (e.g., strains or sprains).

[0008] For non-arthritic joint pain, both rest and exercise are recommended. Warm baths, massage, and stretching exercises can also be used as often as possible. Typically, acetaminophen is taken to help the soreness feel better. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, may also help relieve pain and swelling. While these therapies sometimes help relieve pain, they do not always help sufficiently to help a patient and / or can cause side effects and reactions in the body.

[0009] In view of the above, it is desirable to develop improved compositions and treatment methods to provide relief for joint pain and to increase endurance and / or mobility levels of a joint while exercising or walking.BRIEF SUMMARY OF THE INVENTION

[0010] The present invention is a nutritional supplement. It is a novel composition comprising proteoglycans and phosphatidylserine to improve joint health, such as to provide relief for joint pain and increase endurance / mobility levels while exercising or walking. Other observed joint health benefits include improved pain threshold, improved exercise stamina, increased energy, reduced fatigue, increased working capacity, and increased physical recovery.

[0011] A particular embodiment of the present disclosure relates to an oral nutritional supplement that includes the novel composition. The composition may be delivered as non-toxic salts thereof, effective complexes thereof, stable chelates thereof, active esters thereof, functional derivatives thereof, and mixtures thereof which are effective to improve joint health in the general population.

[0012] Another particular embodiment relates to a topical nutritional supplement that comprises a mixture of proteoglycans and phosphatidylserine.

[0013] Methods of improving joint health comprise administering the novel composition to a mammal subject, such as a human or canine.

[0014] DETAILED DESCRIPTION

[0015] The present invention is drawn to a composition comprising proteoglycans and phosphatidyl serine, which provides fast relief for joint pain and increases endurance / mobility levels while exercising. Methods of providing fast joint health relief and improved mobility / endurance comprise administering the novel composition to a mammal.

[0016] In embodiments of the invention, the nutritional supplement includes a composition comprising proteoglycan and phosphatidylserine in a ratio of 1% to 10% proteoglycans to 90% to 99% phosphatidylserine. In addition the embodiments of the invention, the nutritional supplement includes a composition comprising wherein the proteoglycans and phosphatidylserine are in a ratio range of from 1 :5 to 1 :30 wt / wt. In a particular embodiment, the composition comprises 10 mg proteoglycans and 100 mg phosphatidylserine. In another embodiment, the composition comprises marine proteoglycans and phosphatidylserine in a ration of 10% to 90%. In particular embodiments of the invention, the proteoglycan is a marine proteoglycan.In another embodiment, a method of alleviating joint pain or increasing endurance / mobility of the joint comprises administering the nutritional supplement to a mammal.

[0017] Particular embodiments of the invention relate to oral administration of the disclosed nutritional supplement to a human. The nutritional supplement may be administered from one to three times daily. In particular embodiments, the nutritional supplement may be administered on an empty stomach. In another embodiment of the invention, the composition may be administered topically on the skin. The composition can be administered along with other medications, such as NSAIDs or acetaminophen.

[0018] Each ingredient of the nutritional supplement of the present invention may be prepared in accordance with any method known to one of ordinary skill in the art. Alternatively, each ingredient may be obtained in a fully prepared from a commercially available source.

[0019] The nutritional supplement of the present invention may be in any suitable oral administration form, including but not limited to: a chewable form, a liquid form, a spray form, a capsule form, a suppository form, effervescent form, dissolvable wafer, and a powder form.

[0020] Irrespective of the structural form of the nutritional supplement, the ingredients of the nutritional supplement may be distributed homogeneously or non-homogeneously within the nutritional supplement.

[0021] The nutritional supplement of the present invention may be ingested on a regular basis, such as a daily, at a dosage tailored to an individual's needs; i.e., the nutritional supplement is to be taken regularly as multiples (lx, 2x, etc.) of the structural units (pills, tablets, capsules, liquid dose, etc.) in accordance with the needs of the individual. Alternatively, the nutritional supplement of the present invention may be ingested on an as-needed basis at a dosage tailored to the individual's needs. Medical or nutritional counseling may be beneficial for arriving at a desirable or optimal dosage tailored to the individual's needs. Topical delivery systems such as lotions and creams may apply.

[0022] EXAMPLES

[0023] Example 1 - Studies

[0024] Two studies were conducted as randomized, double-blind, and placebo-controlled clinical trials. The studies population was recruited by a specially trained nurse and a physiotherapistfrom Health Clinics and sports centers in Copenhagen (SATS). Healthy volunteers and sport subjects, male and non-pregnant females, aged 30-75 years were eligible for the study.

[0025] Study 1 : The first study was separated into two groups: PS / PG blend vs. placebo, and PS / PG Blend vs. proteoglycan. For the study, 96 volunteers were recruited and followed over a 4-week period. Treatment allocation was concealed and blinding was maintained by giving the phosphatidylserine(lOOmg) and proteoglycan blend (“PS / PG blend”) (Group 1), versus either a placebo or Proteoglycan (Group 2) in coded containers. The participants, recruiting nurse and the investigators remained blinded during the study period. Study participants took either one tablet of the PS / PG blend, proteoglycan, or a placebo each morning during the study. Measurement of results was conducted on days 4, 7, 14, and 30, and were compared to baseline measurements on day 0.

[0026] Study 2: For the second study, 74 volunteers were recruited and followed over a 4-week period. Treatment allocation was concealed and blinding was maintained by giving the PS / PG blend or a placebo. The participants, recruiting nurse and the investigators remained blinded during the study period. Study participants took one tablet of the PS / PG blend or a placebo each morning during the study. Measurement of results was conducted on days 4, 7, 14, and 30, and compared to baseline measurements on day 0.

[0027] Example 2 - Study Tests

[0028] Stair Climb Test (SCT): SCT was conducted to assess the ability to ascend a flight of stairs, as well as lower extremity strength, power, and balance. The test included participants to perform a “walk upstairs pain-test”. The participants assessed the level of joint pains on a visual analogue scale. The participants used a StairMaster - a stationary fitness machine that rotates steps, similar to a treadmill, allowing the user to climb upward at the speed and duration he or she sets. Days 4, 7, 14, and 30 were compared to baseline assessments on day 0.

[0029] Self-Paced walk test (SPWT): SPWT assesses the time it takes to walk a short distance. Individuals were asked to walk quickly and safely without overexerting themselves. The time it took to cover a specified distance was recorded in seconds. The test was conducted on days 4, 7, 14, and 30 compared to baseline readings on day 0. The test was conducted by the participants using a treadmill.Visual Analogue Scale (VAS): VAS was used as a simplified design to measure pain management. Minimal clinically significant difference (MCDS) is defined as the mean difference between current scores and previous score. After 20 minutes, using a 100 mm VAS scale (100 mm ruler), the subjects gave a verbal rating (every participant will have a VAS ruler developed by Schlenker Enterprises for self-evaluation. VAS scores were scored as follows: • 0-4 mm - no pain

[0030] • 5-44 mm - mild pain

[0031] • 45-74 mm - moderate pain

[0032] • 75-100 mm - severe pain (worst possible)

[0033] For the SCT and VAS, the following parameters were followed to select study participants:

[0034] Age: 30 years to 75 years.

[0035] Moderate to severe knee and hip pain.

[0036] BMI < 30

[0037] General good health.

[0038] Able to comply with study procedures.

[0039] No intake of chondroitin, glucosamine, msm, Boswellia, turmeric, Type II Collagen, PS, for at least 90 days before trial.

[0040] The following study candidates were excluded from the studies:

[0041] • Female subjects who were pregnant at screening or are planning to become pregnant or are currently breastfeeding.

[0042] • Subjects that had concurrent medical or arthritic conditions that could interfere with evaluation of the index knee joint including fibromyalgia, rheumatoid arthritis, or other inflammatory arthropathies affecting the knee joint.

[0043] • Subjects that had undergone arthroscopic or open surgery to the knee within 6 months.

[0044] • Subjects that had treatment knee injections with corticosteroids within 30 days or hyaluronic acid within 3 months prior.

[0045] Example 3 - Study ResultsStudy 1 : PS / PG Blend versus Placebo.

[0046] Improvements from Baseline (day 0).

[0047] Group One: Phosphatidylserine(100mg PS / tablet), Proteoglycan(lOmg),

[0048] Group Two: Proteoglycan(lOmg),

[0049] Group Three: Placebo

[0050]

[0051] < < <

[0052] <

[0053]

[0054] <

[0055]

[0056] <

[0057] ** Statistical significant, Dwass-Steel-Critchlow-Fliger pairwise comparison between Group 1 and Group 2.

[0058] Study 1 : PS / PG Blend versus Group 2 (proteoglycans alone).

[0059] Improvements from Baseline (day 0).

[0060]

[0061] < < <

[0062] 11

[0063]

[0064] < < <

[0065]

[0066] ** Statistical significant, Dwass-Steel-Critchlow-Fliger pairwise comparison between Group 1 and Group 2.

[0067] Study 2: PS / PG Blend versus Placebo.

[0068] Improvements from Baseline (day 0).

[0069] Group One; Phosphatidylserine(100mg PS / tablet), Proteoglycan(lOmg)

[0070] Group Two ; Placebo

[0071] <

[0072] < <

[0073]

[0074] < < < <

[0075]

[0076] < < < < ** Statistical significant, Mann-Whitney U test.

[0077] In sum, the PS / PG Blend showed rapid onset of action within 4 days, showed improved pain threshold, provided improved stamina, increased exercise performance for walking and stair climbing, increased endurance, improved recovery after exercise, increased sustained energy during exercise, reduced fatigue, and increased working capacity. The PS / PG blend significantly outperformed the PG alone and the placebo group.

Claims

CLAIMS1. A composition for promoting j oint health, comprising:proteoglycan and phosphatidylserine.

2. The composition of claim 1, wherein promoting joint health care comprises promoting physical endurance, decreasing joint pain, increasing physical mobility, promoting mobility, improving joint pain, improving stamina, increasing energy, reducing fatigue, increasing working capacity, and increasing physical recovery.

3. The composition of claim 1, wherein the proteoglycan comprises a marine proteoglycan.

4. The composition of claim 1, wherein the proteoglycans and phosphatidylserine are in a ratio range of from 1 :5 to 1 :30 wt / wt.

5. The composition of claim 1, wherein the marine proteoglycans and phosphatidylserine are in a ratio of 1% to 10% proteoglycans to 90% to 99% phosphatidyl serine.

6. The composition of claim 1, wherein the composition comprises lOmgs proteoglycans and lOOmgs phosphatidylserine.

7. The composition of claims 1-6, wherein the composition is formulated as an oral agent.

8. The composition of claims 1-6, wherein the composition is formulated as a chewable form, a liquid form, a spray form, lotion form, cream form, a capsule form, effervescent, dissolvable wafer, or a powder form.

9. The composition of claims 1-6, wherein the composition may be delivered as complexes thereof, stable chelates thereof, active esters thereof, functional derivatives thereof, and mixtures thereof.

10. The composition of claims 1-6, wherein the composition is formulated as a topical agent.

11. A method of promoting joint health, comprising administering the composition of claims 1-10 to a mammal or human subject.

12. The method of claim 11, wherein the composition is administered from one to three times daily.

13. A composition for increased mobility, comprising:proteoglycan and phosphatidyl serine.

14. The composition of claim 13, wherein the composition comprises lOmgs proteoglycans and lOOmgs phosphatidylserine.

15. A composition for increased endurance, comprising:proteoglycan and phosphatidylserine.

16. The composition of claim 14, wherein the composition comprises lOmgs proteoglycans and lOOmgs phosphatidylserine.

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