PRIORITY CLAIM This application claims the benefit of the filing date of United States Patent

Application Serial Number 13/623,116, filed September 20, 2012, for "METHODS FOR IMPROVING THYROID FUNCTION IN HEALTHY HUMANS."

TECHNICAL FIELD

Embodiments of the invention generally relate to methods for increasing improving thyroid function in healthy human beings.

BACKGROUND

Thyroid hormones are critical for normal growth and development and for maintaining metabolic homeostasis. Yen (2001) Physiol. Rev. 81(3): 1097-126. Circulating levels of thyroid hormones are tightly regulated by feedback mechanisms in the neuroendocrine axis (i.e., the HPT axis). Thyroid hormones exert profound effects on cardiac function, body weight, metabolism, metabolic rate, body temperature, cholesterol, bone, muscle, and behavior.

Subclinical thyroid diseases (e.g., subclinical hyperthyroidism and subclinical hypothyroidism) are common clinical entities that encompass mild degrees of thyroid dysfunction. The clinical significance of mild thyroid under-activity is uncertain, and therefore there is considerable controversy over the appropriateness of diagnostic testing and possible treatment of this condition. Cooper (2012) Lancet 379(9821): 1142-54; Wilson & Curry (2005) AAFP 72(8). Subclinical hypothyroidism is typically defined as a serum thyroid-stimulating hormone (TSH) concentration above the statistically defined lower limit of the reference range, 0.45 to 4.50 μυ/mL (0.45 to 4.50 mU/L), when serum free T ₄ thyroxine concentration are within its reference range. Subclinical hypothyroidism is associated with progression to overt disease.. See, e.g., Wilson & Curry (2005).

Estimates of the incidence of subclinical hypothyroidism range between 3-8%. The incidence of subclinical hypothyroidism steadily increases with age, and it is more common in women than in men. Older adults are twice as likely to develop hypothyroidism as younger adults, the condition is commonly accompanied by symptoms including, for example, constipation, weight gain, dry and itchy skin, impaired cognitive function, and intolerance to cold.

Somatostatin (also known as growth hormone-inhibiting hormone (GHIH)) is a peptide hormone that regulates the endocrine system and affects neurotransmission and cell proliferation via its interaction with G-protein-coupled receptors and inhibition of the release of secondary hormones. For example, in the anterior pituitary gland, somatostatin inhibits the release of TSH and growth hormone.

It is well-established that intravenous (IV) administration of some amino acids results in significant inhibition of somatostatin; indeed this type of diagnostic testing for human growth hormone deficiency (another hormone regulated in part by somatostatin) (Merimee TJ et al. N Engl J Med 1969;280:1434-1438; Alba-Roth J et al. J Clin Endocrinol Metab 1988;67: 1186-1189). Other amino acids, such as methionine, phenylalanine, lysine, histidine, and ornithine have also led to marked increases in hGH (Alba-Roth, Muller, Schopohl, & von Werder, 1988; Chromiak & Antonio, 2002; Gourmelen, M., M. Donnadieu, et al. (1972) Ann Endocrinol (Paris) 33(5): 526-528).

Determination of an effective and safe oral functional blend that improves thyroid function in the general population with sub-clinical thyroid function is important to determine.

Symptoms such as cold hands and feet, sensitivity to cold, headaches, sleeplessness, coarse skin, swollen eyes, fragile nails, joint aches, constipation, fatigue, croaky voice, and dizziness are associated with subclinical hypothyroidism, and could be treated by improving thyroid function.

It would be desirable to provide a nutritional supplement for improving thyroid function, in particular an amino acid-containing composition that is well tolerated having the result of increasing or improving thyroid function in those individuals whose thyroid function has slowed as a function of increasing age (sub-clinical hypo-thyroid function) or otherwise desire thyroid support. BRIEF SUMMARY OF THE INVENTION

The present invention is a nutritional supplement and method of using the same. It is a novel amino acid-containing composition, which, taken orally, stimulates improves thyroid function in healthy humans.

A particular embodiment of the present disclosure relates to an oral nutritional supplement that includes the amino acids 1-lysine, 1-arginine, oxo-proline, and one of either cysteine or glutamine. The amino acids 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 thyroid function in the general population.

Another particular embodiment relates to an oral nutritional supplement that consists essentially of 1-lysine HC1, 1-arginine HC1, oxo-proline, N-acetyl-l-cysteine, 1-glutamine, and schizonepeta (aerial parts) powder.

Other embodiments are drawn to methods of improving thyroid function in humans that include orally administering the disclosed nutritional supplement to a healthy human being.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a nutritional supplement for use by a human being. The present invention is drawn to a nutritional supplement and method of using the same. The nutritional supplement is an amino acid-containing composition, which, taken orally, improves thyroid function in healthy volunteers. For example, the nutritional supplement may prevent the occurrence or reduce the severity of at least one symptom associated with hypothyroidism, including for example and without limitation, cold hands and feet, sensitivity to cold, headaches, sleeplessness, coarse skin, swollen eyes, fragile nails, joint aches, constipation, fatigue, croaky voice, and dizziness. The supplement of the present invention works as a dietary supplement by assisting the body's own ability to improve thyroid function naturally in a manner that is safe and effective, as well as being affordable.

A particular embodiment of the present disclosure relates to an oral nutritional supplement that includes 1-lysine, 1-arginine, oxo-proline, and one of either cysteine or glutamine. The supplement may additionally include both cysteine and glutamine and/or schizonepeta powder. In particular embodiments, a functional dosage includes the 1-arginine at a level between 0.1-6 moles and the oxo-proline between 0.1-8 moles, and/or the 1-lysine in an amount between 0.1-12 moles. The cysteine and/or glutamine may be contained at a level between 0.001-6 moles. The cysteine can be n-acetyl L-cysteine and the glutamine may be 1-glutamine. The amino acids 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 increase hGH levels in the general population. The nutritional supplement may be present in an amount of 2.9 grams. The nutritional supplement may be in any acceptable and known oral formulation, such as powder, tablet, capsule, liquid, or wafer form.

Another particular embodiment relates to an oral nutritional supplement that consists essentially of 1-lysine HC1, 1-arginine HC1, oxo-proline, N-acetyl-l-cysteine, 1-glutamine, and schizonepeta (aerial parts) powder. In particular embodiments, a functional dosage includes the 1-arginine HC1 at a level between 0.1-6 moles and the oxo-proline between 0.1-8 moles, and/or the 1-lysine HC1 in an amount between 0.1-12 moles. The n-acetyl L-cysteine and/or 1-glutamine may be contained at a level between 0.001-6 moles. In another particular embodiment, a functional dosage includes the 1-arginine HC1 at a level between 2.5-4.5 moles and the oxo-proline between 4-6 moles, and/or the 1-lysine HC1 in an amount between 7-9 moles. The n-acetyl L-cysteine and/or 1-glutamine may be contained at a level between 0.001-0.5 moles. The nutritional supplement may be in any acceptable and known oral formulation, such as powder, tablet, capsule, liquid, or wafer form.

Other embodiments are drawn to methods of improving thyroid function in humans that include orally administering the disclosed nutritional supplement to a healthy human being. As used herein, "healthy human being" means a human being without any physiological deficiency in thyroid function, but rather has symptoms of sub-clinical hypothyroid function. Particular embodiments of the invention relate to oral administration of the disclosed nutritional supplement to a human that is at least 30 years old. The nutritional supplement may be administered from one to three times daily or, alternatively, may be administered every other day, or may be administered once a week. In particular embodiments, the nutritional supplement may be administered on an empty stomach.

In accordance with the "consist essentially of and "consisting essentially of language, the nutritional supplement of the third embodiments is essentially limited to the aforementioned ingredients and does not include any additional active ingredients intended to add nutritional content (e.g., vitamins, minerals, etc.), but may include additional ingredients not intended to add nutritional content such as ingredients intended to fulfill a non-nutritional purpose (e.g., coloring, fillers, flavoring, an ingredient for maintaining the structural form, etc.).

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.

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, dissolvable wafer, and a powder form.

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.

The nutritional supplement of the present invention may be ingested on a regular basis, such as a daily or weekly intake at a dosage tailored to an individual's needs; i.e., the nutritional supplement is to be taken regularly as multiples (1 x, 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.

The combination of types of amino acids, mass ranges, and specific formulations have been selected to be synergistically balanced and of adequate quantity to achieve the desired physiological effect, namely, thyroid support. Improper combinations of the amino acids may be ineffective. The component amino acids are synergistic in the sense that several of them when combined together, synergistically improve thyroid function. The combination was also chosen to reduce or inhibit chemical combination or reaction between the amino acids.

EXAMPLES

Methods: This cross-over, placebo controlled, double-blind study involved 16 healthy subjects [12 males, 4 females; 9 Caucasian, 6 African American, 1 other; mean age= 32±14 years; body mass index=26.4 ± 5.0 ranging from 19.1 to 36.8kg/m ]. Each subject reported to the Inpatient Unit on two occasions one week apart. After an overnight fast, subjects had an IV line placed and baseline bloods samples were drawn at -30, -15, and 0 minutes. Subjects were then asked to swallow the capsules of the test supplement or an identical looking placebo.

The administered supplement is a novel 2.9g/dose blend of 1-lysine HC1, 1-arginine HC1, oxo-proline, N-acetyl-l-cysteine, 1-glutamine, and schizonepeta (aerial parts) powder. Blood was drawn at regular intervals for 120 minutes after administration. Baseline and 120 minute time points were assayed for triiodothyronine (T3).

As daily circadian levels of T3 naturally decrease during the morning hours, at which the current trial was scheduled, it was not surprising that placebo levels between the baseline and 120 minute time points decreased by -6.10 ng/dL (106 to 100 ng/dL, P=0.01). In contrast, the SERO VITAL® group exhibited a deceased reduction inT3 by nearly one-half over the same time course, -3.3 ng/dL (101-97.3 ng/dL, NS), which was not a significant reduction compared to baseline, as was the reduction in the placebo group. These results affirm that supportive function of SERO VITAL® in thyroid function.

This study is distinct in that it had a broad range of ages and BMFs and included both genders. An additional advantage of this study of the novel amino-acid containing blend is that it contained a placebo control group and was randomized and double-blinded.

While embodiments of the present invention have been described herein for purposes of illustration, many modifications and changes will become apparent to those skilled in the art. Accordingly, the appended claims are intended to encompass all such modifications and changes as fall within the true spirit and scope of this invention.