US20070298097A1 - Multi-carotenoids compositions and uses therefor - Google Patents

Multi-carotenoids compositions and uses therefor Download PDF

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US20070298097A1
US20070298097A1 US11/695,354 US69535407A US2007298097A1 US 20070298097 A1 US20070298097 A1 US 20070298097A1 US 69535407 A US69535407 A US 69535407A US 2007298097 A1 US2007298097 A1 US 2007298097A1
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nutritional supplement
weight
carotene
supplement composition
lycopene
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Fu Feng Kuo
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Dominic Natural Biotech Inc
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Dominic Natural Biotech Inc
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Publication of US20070298097A1 publication Critical patent/US20070298097A1/en
Priority to US12/479,094 priority Critical patent/US9044407B2/en
Priority to US12/545,287 priority patent/US10022414B2/en
Priority to US14/658,060 priority patent/US10561696B2/en
Abandoned legal-status Critical Current

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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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    • A23L5/44—Addition of dyes or pigments, e.g. in combination with optical brighteners using naturally occurring organic dyes or pigments, their artificial duplicates or their derivatives using carotenoids or xanthophylls
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    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K9/4875—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • compositions comprising a plurality of carotenoid compounds. More particularly, the present invention is directed to nutritional supplement compositions comprising at least lycopene, phytoene and phytofluene, configured for oral administration as a nutritional supplement. The present invention also relates to methods for use of said compositions disclosed herein.
  • Carotenoids are a group of pigments that are characterized by the color including and ranging from yellow to red. Carotenoids are commonly produced by a wide variety of plant materials and most commonly associated with plants such as tomatoes, carrots and peppers.
  • Lycopene and its precursor phytofluene are caroteniods commonly found in tomatoes and are the predominant sources of the bright red color associated with tomatoes.
  • Phytoene is a precursor to phytofluene, lycopene and other carotenoids, and is also found in high concentrations in tomatoes. Lycopene is generally present in the plasma of the human body; the serum concentrations of lycopene are typically about 2.5 times higher than those of ⁇ -carotene and 7.5 times greater than those of ⁇ -carotene.
  • Carotenoids are known to have antioxidant properties and consequently, provide numerous beneficial health effects including reducing the potential risks of cardiovascular diseases, cancers, and slowing and/or reversing the degenerative effects of aging on various human physiological activities.
  • Prostate cancer and benign prostatic hyperplasia are aging-related conditions that affect prostate gland physiology and impair urinary function in men. As many men age, their prostate glands slowly enlarge causing (a) obstructive symptoms exemplified by weak and/or intermittent urinary streams, a sense of residual urine in the bladder after voiding, and dribbling or leakage at the end of urination, and/or (b) irritative symptoms as exemplified by urgency of micturation, increased frequency of urination, and uracratia. Obstructive and irritative urinary symptoms are commonly referred to as lower urinary tract symptoms (LUTS).
  • LUTS lower urinary tract symptoms
  • the current treatments of prostrate cancer, BPH and LUTS symptoms consist of drug therapies and major surgery.
  • the two primary drug classes used are alpha-blockers and 5-alpha-reductase inhibitors, which should be taken for life in order to get the persistent efficacy.
  • the results are usually positive, but there are risks associated with such surgical operations.
  • compositions useful for oral administration as nutritional supplements wherein the compositions comprise at least lycopene, phytoene, phytofluene components, and a suitable carrier.
  • the lycopene, phytoene, and phytofluene components of the multi-carotenoid compositions of the present invention are preferably naturally occurring and are preferably extracted from tomatoes as pulp.
  • the tomato pulp is suitably processed into oleoresins or beadlet or dry powder materials.
  • the multi-carotenoid compositions of the present invention comprise said oleoresin, or beadlet, or dry powder materials, are suitably encapsulated in soft-gel capsules, or alternatively, in “hard” capsules, or optionally, configured into tablets, or if so desired, into sachet packets, and like.
  • the tomato extracts comprising the multi-carotenoids compositions of the present invention may additionally contain therein addition to the lycopene, phytoene, and phytofluene components, one or more of ⁇ -carotene, ⁇ -carotene, and ⁇ -carotene, a phytosterol, a tocopheral and a phospholipid.
  • An exemplary formulation of the multi-carotenoids compositions comprises lycopene, phytoene, phytofluene, and vitamin E components with trace amounts of ⁇ -carotene, ⁇ -carotene, and ⁇ -carotene, within a tomato oil matrix encased in a soft gel capsule.
  • the exemplary formulation may additionally comprise an edible oil exemplified by soya oil, pumpkin seed oil, grapeseed oil and the like.
  • the multi-carotenoids compositions disclosed herein thereby regularly providing an effective amount of lycopene useful for ameliorating the effects of aging-related urinary impairments and malfunctions in men.
  • urinary impairments and malfunctions are exemplified by benign prostatic hyperplasia, prostate cancer, lower urinary tract symptoms such as obstructive symptoms and irritative symptoms, and the like.
  • the present invention provides stable multi-carotenoids compositions useful for oral administration as nutritional supplements, wherein the compositions comprise at least lycopene, phytoene, phytofluene components contained within an extract produced from tomato fruits.
  • suitable tomato fruits are produced by non-genetically engineered plants, and preferably contain high concentrations of lycopene.
  • the compositions are preferably encased in a soft gel capsule and may additionally comprise an edible oil exemplified by soya oil, pumpkin seed oil, grapeseed oil and the like.
  • the lycopene, phytoene and phytofluene components are preferably processed from tomato fruits into extracts.
  • the components may be concentrated by removing water from the extracts thereby producing thickened pulps that contain therein the lycopene, phytoene and phytofluene components, and additionally comprise ⁇ -carotene, ⁇ -carotene, ⁇ -carotene, vitamin E, a plurality of phytosterols and phospholipids.
  • the thickened pulps may be further suitably processed into oleoresin-based emulsions.
  • the oleoresins may be encapsulated within soft gel capsules comprising soya oil or alternatively, pumpkin seed oil.
  • the tomato extracts may be optionally formulated into beadlets that may be packaged if so desired in sachet packets, or alternatively, dried and processed into powders that may be optionally encapsulated or alternatively, tabletted.
  • a suitable multi-carotenoids composition of the present invention is a soft gel capsule configured for oral administration as a nutritional supplement and comprises about: (a) 71% by weight of a tomato extract containing about 2% to 10% by weight of lycopene, 0.25% to 2% by weight of phytoene, 0.2% to 2% by weight of phytofluene, trace amounts of carotene, ⁇ -carotene, ⁇ -carotene, ⁇ -carotene, vitamin E, phytosterols and phospholipids, and (b) 29% weight of a suitable encapsulating matrix exemplified by soya oil or pumpkin seed oil.
  • An exemplary multi-carotenoids composition is a soft gel capsule weighing about 350 mg and comprising firstly, about 250 mg of a tomato oleoresin containing: (a) about 15 mg of lycopene, (b) about 1.5 mg of phytoene, (c) 1.25 mg of phytofluene, (d) about 0.5 mg of vitamin E, (e) about 5 mg of ⁇ -carotene, (f) about 1.5 mg of a phytosterol, and (g) 25 mg of a phospholipid, and secondly, about 100 mg of soya oil or alternatively, about 100 mg of pumpkin seed oil and the like.
  • a tomato oleoresin containing: (a) about 15 mg of lycopene, (b) about 1.5 mg of phytoene, (c) 1.25 mg of phytofluene, (d) about 0.5 mg of vitamin E, (e) about 5 mg of ⁇ -carotene, (f) about 1.5 mg of a phytosterol, and (g) 25 mg of a
  • a 12-week clinical study was initiated with a group of 74 males divided into two sub-groups of 37 individuals each, to assess the effects of an exemplary capsule formulation of the multi-carotenoids composition of the present invention. Twelve individuals were subsequently withdrawn from the study, and the remaining 63 subjects were divided into: (a) a first group of 29 subjects who received a daily oral dose of one 350-mg capsule of the exemplary capsule of the present invention thereby providing a daily nutritional supplement of 15 mg of lycopene, and (b) a second group of 32 subjects who received a daily oral dose of two 350-mg capsules of the present invention thereby providing a daily nutritional supplement of 30 mg of lycopene, on selected clinical parameters associated with prostate and urinary system health.
  • the inclusion criteria for the trial were male subjects over 40 years of age with no prior history or indicators of prostate and/or other cancers, the subjects' PSA levels were between 2.5 and 20.0 ng/ml, and their renal and liver functions were within normal ranges.
  • the exclusion criteria were individuals with fluctuating PSA levels, recent medical histories of urinary tract infection, prostatitis, acute urinary retention, individuals with known allergic reactions to carotenoids, individuals taking medications that may alter serum PSA levels as exemplified by 5- ⁇ reductase inhibitors, steroids or hormonal agents, and medications for lower urinary tract infections.
  • the trial followed a general protocol of, first, screening, evaluation and selection of the individuals for participating in the trial.
  • the individuals in each group received their daily dosage for 12 consecutive weeks. Each indvidual's was sampled after one week (i.e., the second sample), after four weeks (i.e., the third sample) and after twelve weeks (i.e., the fourth sample).
  • Each serum sample was assayed to quantitatively determine therein the PSA, lycopene, creatine, bilirubin, alanine amino transferase, hemoglobin, cholesterol, low-density lipoprotein, high-density lipoprotein, and testosterone levels.
  • the test individuals were also responded to questions regarding their urinary functions taken from the International Prostate Symptom Score (IPSS) index developed and validated by a multidisciplinary measurement committee of the American Urological Association (Fowler et al., 1992, Journal of Urology 148:1549-57).
  • IPS International Prostate Symptom Score
  • the time “0” data (i.e., the first sample) are shown in Table 1.
  • Individuals receiving a daily lycopene dose of 15 mg via one capsule daily of the exemplary composition of the present invention showed a 2.6 times increase in their serum lycopene levels, while individuals receiving a daily lycopene dose of 30 mg via two capsules daily showed a 3-fold increase in their serum lycopene levels (Table 2).
  • test individuals from both daily dosage groups showed progressive declines in their obstructive IPSS scores and their irritative IPSS scores over the 12-week study (Table 6).
  • Table 6 Changes in obstructive and irritative IPSS scores during 12 weeks of supplementation with the exemplary composition of the present invention*.
  • the exemplary embodiments of the present invention comprising multi-carotenoids nutritional supplement compositions as disclosed herein for provision of a daily nutritional supplement of at least 15 mg of lycopene, are useful for ameliorating the effects of aging-related impaired urinary functions in men as exemplified by BPH, LUTS, prostrate cancer and the like.

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US11/695,354 2006-04-03 2007-04-02 Multi-carotenoids compositions and uses therefor Abandoned US20070298097A1 (en)

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Application Number Priority Date Filing Date Title
US12/479,094 US9044407B2 (en) 2006-04-03 2009-06-05 Multi-carotenoids compositions and uses therefor
US12/545,287 US10022414B2 (en) 2006-04-03 2009-08-21 Multi-carotenoids compositions and methods
US14/658,060 US10561696B2 (en) 2006-04-03 2015-03-13 Multi-carotenoids compositions and uses therefor

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TW095111722 2006-04-03
TW095111722A TW200738227A (en) 2006-04-03 2006-04-03 One kind of multi-carotenoids and its administration

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US12/545,287 Continuation-In-Part US10022414B2 (en) 2006-04-03 2009-08-21 Multi-carotenoids compositions and methods

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CN103141845A (zh) * 2013-03-22 2013-06-12 山东三星玉米产业科技有限公司 一种植物甾醇软胶囊及其制备方法
JP2017501996A (ja) * 2013-12-11 2017-01-19 ヘルス−エバー バイオテック カンパニー リミテッド カロテノイドの医薬組成物
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CN115734714A (zh) * 2020-03-24 2023-03-03 C·V·萨万基卡尔 富含β-胡萝卜素的油

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US20090239825A1 (en) 2009-09-24
CA2583658C (fr) 2020-02-11
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