COMPOSITIONS AND METHODS FOR THE TREATMENT OR PROPHYLAXIS OF CIRCADIAN PROTEIN RELATED CONDITIONS
Provided are compositions and processes of treating or preventing one or more conditions related to a protein involved in circadian rhythm. A composition includes an extract of rosemary, an extract of hemerocallis fulva , active portion or component thereof, or combinations thereof, optionally provided as a component of a dietary supplement. The presence of one or more active ingredients in the extracts optionally administered at a targeted administration time alters the expression of one or more genes or proteins involved in circadian rhythm, illustratively CLOCK, BMAL1, FBXL3, FBXL21, or SIRT1.
1 . A composition for the treatment or prevention of a disease or condition related to the expression of a circadian rhythm related protein comprising:
an effective amount of an extract of rosemary, an extract of hemerocallis fulva , active portion or component thereof, or combinations thereof, said extract formulated for administering to a subject in need of treatment of a disease or condition related to a circadian rhythm; and
ameliorating, preventing, or modulating a symptom of said disease or condition in said subject whereby said effective amount is sufficient to alter one or more expression characteristics of a protein selected from the group consisting of CLOCK, BMAL1, FBXL3, FBXL21, SIRT1, or combinations thereof, in said subject.
2 . The composition of claim 1 wherein said extract is a water extract.
3 . The composition of claim 1 wherein extract is a component in a dietary supplement.
4 . The composition of claim 1 wherein said administering is once daily.
5 . The composition of claim 1 wherein said extract is an extract of rosemary and said protein is the BMAL1 protein.
6 . The composition of claim 1 wherein said extract is an extract of rosemary and said protein is FBXL3, FBXL21, or combinations thereof.
7 . The composition of claim 1 wherein said extract is an extract of rosemary and said protein is SIRT1.
8 . The composition of claim 1 wherein said extract is an extract of hemerocallis fulva and said protein is CLOCK.
9 . The composition of claim 1 wherein said extract is an extract of hemerocallis fulva and said protein is BMAL1.
10 . The composition of claim 1 wherein said extract is an extract of hemerocallis fulva and said protein is FBXL3, FBXL21, or combinations thereof.
11 . The composition of claim 1 wherein said extract is an extract of hemerocallis fulva and said protein is SIRT1.
12 . The composition of any one of claims 1 - 11 wherein said disease or condition is jet lag.
13 . The composition of claim 12 wherein said administration is prior to or following travel involving a change in time zone.
14 . The composition of any one of claims 1 - 11 wherein said disease or condition is a hangover.
15 . The composition of claim 14 wherein said extract is administered prior to, during, or following the consumption of alcohol, or combinations thereof.
16 . The composition of any one of claims 1 - 11 wherein said disease or condition is a metabolic condition related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, or SIRT1.
18 . The composition of claim 16 wherein said metabolic conditions is abnormal cholesterol level, obesity, metabolic syndrome or element thereof, hyperglycemia, hypoglycemia, abnormal insulin production, or diabetes.
19 . The composition of any one of claims 1 - 11 wherein said disease or condition is an inflammatory disorder related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
20 . The composition of any one of claims 1 - 11 wherein said disease or condition is a neurological disorder related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
21 . The composition of claim 20 wherein said neurological disorder is Alzheimer's disease.
22 . The composition of any one of claims 1 - 11 wherein said disease or condition is a muscular disorder related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
23 . The composition of claim 22 wherein said muscular disorder is muscular dystrophy or myopathy.
24 . The composition of any one of claims 1 - 11 wherein said disease or condition is a sleep disorder related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
25 . The composition of claim 24 wherein said sleep disorder is insomnia, jet lag, shift work sleep disorder, delayed sleep phase syndrome (DSPS), advanced sleep phase syndrome (ASPS), non 24-hour sleep wake disorder or irregular sleep-wake pattern.
26 . The composition of claim 25 wherein said administration is from −4 hours to 12 hours or 0 to 12 hours after light exposure.
27 . The composition of claim 25 wherein said administration is from 1-3 hours after light exposure or 10-14 hours after light exposure.
28 . The composition of claim 25 wherein said administration is from 4 hours to 0 hours prior to light exposure.
29 . The composition of any one of claims 1 - 11 wherein said disease or condition is a psychiatric disorder related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
30 . The composition of claim 29 wherein said psychiatric disorder is depression, seasonal affective disorder, dementia, or rapid-cycling bipolar disorder.
31 . The composition of any one of claims 1 - 11 wherein said disease or condition is a cardiovascular disorder related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
32 . The composition of claim 31 wherein said cardiovascular disorder is abnormal blood pressure or abnormal heart rate.
33 . The composition of claim 31 wherein said cardiovascular disorder is atherosclerosis or cardiomyopathy.
34 . The composition of any one of claims 1 - 11 wherein said disease or condition is a liver toxicity related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
35 . The composition of any one of claims 1 - 11 wherein said disease or condition is a disorder of the brain related to an expression characteristic of one or more of CLOCK, BMAL1, FBXL3, FBXL21, of SIRT1.
36 . The composition of claim 35 wherein said disorder of the brain is stroke or brain degeneration due to free radicals.
37 . The composition of any one of claims 1 - 11 wherein said composition is administered on an as needed basis.
38 . The composition of any one of claims 1 - 11 wherein said protein is not SIRT1.
39 . The composition of any one of claims 1 - 11 wherein said extract comprises ursolic acid at 10% by weight or greater.
40 . The composition of any one of claims 1 - 11 wherein said extract comprises ursolic acid at 25% by weight or greater.
41 . The composition of any one of claims 1 - 11 wherein said extract consists of ursolic acid.
42 . The composition of any one of claims 1 - 11 wherein said administration is for a period of 2 weeks or more.
43 . The composition of any one of claims 1 - 11 wherein said administration is for four weeks or more.
44 . The composition of any one of claims 1 - 11 wherein said administration is for three months or more.
45 . The composition of any one of claims 1 - 11 wherein said administration is once, twice, three, or four times daily.
46 . The composition of claim 3 wherein said dietary supplement is in the form of a powder, gel, liquid, food, solid, or other form.
47 . A composition for treating or preventing obesity in a subject in need thereof comprising:
an extract of rosemary, an extract of hemerocallis fulva , active portion or component thereof, or combinations thereof, said extract for administration to a subject in need of treatment or prevention of obesity;
said obesity related to an expression characteristic or CLOCK, BMAL1, FBXL3, FBXL21, SIRT1, or combinations thereof;
and ameliorating, preventing, or modulating obesity in said subject whereby said effective amount is sufficient to alter one or more expression characteristics of a protein selected from the group consisting of CLOCK, BMAL1, FBXL3, FBXL21, SIRT1, or combinations thereof, in said subject.
48 . A composition for treating or preventing cancer in a subject in need thereof comprising:
an extract of rosemary, an extract of hemerocallis fulva , active portion or component thereof, or combinations thereof, said extract for administration to a subject in need of treatment or prevention of cancer;
said cancer related to an expression characteristic or CLOCK, BMAL1, FBXL3, FBXL21, SIRT1, or combinations thereof;
and ameliorating, preventing, or modulating cancer in said subject whereby said effective amount is sufficient to alter one or more expression characteristics of a protein selected from the group consisting of CLOCK, BMAL1, FBXL3, FBXL21, SIRT1, or combinations thereof, in said subject.
49 . A process substantially as described in the specification.
50 . A composition substantially as described in the specification.