EP3461260A1 - Zusammensetzungen mit l-theanin, proanthocyanidin und catechin sowie verwendungen davon - Google Patents

Zusammensetzungen mit l-theanin, proanthocyanidin und catechin sowie verwendungen davon

Info

Publication number
EP3461260A1
EP3461260A1 EP17799731.9A EP17799731A EP3461260A1 EP 3461260 A1 EP3461260 A1 EP 3461260A1 EP 17799731 A EP17799731 A EP 17799731A EP 3461260 A1 EP3461260 A1 EP 3461260A1
Authority
EP
European Patent Office
Prior art keywords
composition
extract
theanine
proanthocyanidin
epicatechin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP17799731.9A
Other languages
English (en)
French (fr)
Other versions
EP3461260A4 (de
Inventor
Andrew Belton Scholey
Angus Ross BROWN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alphagen Nz Ltd
Original Assignee
Alphagen Nz Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alphagen Nz Ltd filed Critical Alphagen Nz Ltd
Priority claimed from PCT/NZ2017/050058 external-priority patent/WO2017200391A1/en
Publication of EP3461260A1 publication Critical patent/EP3461260A1/de
Publication of EP3461260A4 publication Critical patent/EP3461260A4/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—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
    • 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 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/13—Coniferophyta (gymnosperms)
    • A61K36/15—Pinaceae (Pine family), e.g. pine or cedar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/45—Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia

Definitions

  • the present invention relates to a functional composition and uses thereof, and in particular towards a composition that maintains or improves mental clarity.
  • mental clarity should be considered the absence or suppression of distracting thoughts and feelings (i.e. internal distractions potentially caused by nervousness or uncertainty), the suppression of distracting or irrelevant sensory input (i.e. external distractions), together with reasonable level of vigour.
  • This is compared to improved attention or cognitive performance, with the differentiation that a person may be attentive or have an improved level of "cognitive performance" but also be highly nervous or uncertain.
  • a person can be still very attentive but may not have mental clarity.
  • Mental clarity is sought after because it allows people to remain calm and unstressed, but still be able to make rational decisions, remain concentrated and determined at a job at hand.
  • Bayer markets a range of Berocca ® products to support mental alertness.
  • the energy drink sector has enjoyed huge growth over recent years, based on health claims and marketing towards improving cognitive performance for a period of time after consuming the beverage, which also must taste good for commercial success.
  • Most of these energy drinks rely on high levels of caffeine, and/or often have many unhealthy, or potentially harmful, ingredients in order to enhance the desired stimulatory effect or provide a beneficial taste.
  • caffeine based energy drinks ideally may improve alertness to some extent, but as a side effect they can lead to a sense of hyperactivity, a loss of calmness, increased feeling of stress, a racing heart or a general uncomfortable jittery feeling, similar to the effects of having too much coffee.
  • consuming too many of these energy drinks is a potential health concern.
  • the active agents may unintentionally negate one another, or provide unwanted results.
  • combining different compounds together in attempt to provide synergies also can lead to potential issues with incompatibility/instability, or can negatively affect the sensory perception profile of a given composition.
  • a composition including: a) L-theanine; b) proanthocyanidin(s); and c) a catechin selected from the group consisting of epigallocatechin gallate, epigallocatechin, epicatechin gallate, epicatechin and combinations thereof.
  • composition including: a) L-theanine; b) an extract from pine bark; and c) an extract from Camellia sinensis or a green tea.
  • compositions as herein described for the manufacture of a medicament for maintaining or improving mental clarity in a healthy individual.
  • a method of manufacturing a composition as herein described wherein the method includes the steps of mixing: a) L-theanine or a source thereof; b) proanthocyanidin(s) of a source thereof; and c) a catechin selected from the group consisting of epigallocatechin gallate, epigallocatechin, epicatechin gallate, epicatechin and combinations thereof.
  • a trial composition according to the present invention led to an overall improvement in mental clarity after consumption, including: a better ability to quickly dispense with distracting or misleading information; a reduction of a sense of nervousness / tension / anxiety; a reduction of a sense uncertainty / confusion / bewilderment; an improved sense of vigour / liveliness / activity; no feeling of increased fatigue.
  • composition tested showed remarkable and unexpected results in terms of improved mental clarity. If fact, the inventors were actually expecting a different result in relation to improved cognitive performance, specifically around heightened memory, processing speeds, attention, and so forth. Such effects was not observed, but the unexpected mental clarity outcome seen was subsequently actually considered a more commercially important result.
  • composition has a good sensory perception, despite difficulties with poor taste or mouth feel of some individual components. Additionally, the product has good storage stability, which again was unpredictable given the significant number of active ingredients in the composition and the potential for incompatibility / interaction with the active agents.
  • the inventive composition may be formulated into a range of potential products.
  • the composition may be formulated as a liquid or semi-liquid beverage or as a food supplement such as a pill, capsule or powder.
  • the composition may be formulated into a food item, such as a chocolate bar, or other similar snack.
  • the composition is formulated as a beverage.
  • mental clarity should be understood to include the absence, suppression or reduction of distracting thoughts and feelings (i.e. internal distractions potentially caused by tension or anxiety (e.g. nervousness) and/or confusion and bewilderment (e.g. uncertainty), the suppression or quicker identification of distracting, incorrect or irrelevant sensory input (i.e. external distractions), and/or an improved level of vigour.
  • Mental clarity is a specific subset of overall mental performance, the latter which includes other factors such as composite memory, verbal memory, visual memory, processing speed, executive function, psychomotor speed, reaction time, complex attention, cognitive
  • composition provides a significantly improved mental clarity for a period of about four hours after consumption compared to the control group.
  • L-theanine should be understood to mean y-glutamylethylamide, or a suitable source of L-theanine, such as a green tea extract (Camellia sinensis, or other species of Camellia) or the edible mushroom Xerocomus badius.
  • a green tea extract Camellia sinensis, or other species of Camellia
  • the invention does not cover D- theanine.
  • Synthetically derived L-theanine may also be used, or even L-theanine derivatives thereof, if shown to also provide the same functionality as described herein.
  • L-theanine is water soluble, known to cross the blood-brain barrier, and reaches peak concentrations about one hour after consumption.
  • the composition includes at least 50 mg L-theanine.
  • Previous studies suggest that effects of L-theanine are observed at as little as 50 mg dosage; however the Applicant expects the beneficial effects will be seen between about 50 to 500 mg per dosage.
  • the composition includes about 50-200 mg L-theanine.
  • the concentration of L-theanine is above 0.005% w/v, more preferably between 0.015 to 0.17 % w/v, and most preferably about 0.08% w/v.
  • proanthocyanidin should be understood to mean a class of polyphenols typically found in plants which are known to have powerful antioxidant properties.
  • Proanthocyanidins are found in grapes, cranberry, apples, blueberries, and many other sources.
  • a good source of proanthocyanidins is from pine bark extracts, from Pinus radiata (which is grown
  • pine bark extracts e.g. Enzogenol ® or Pycnogenol ®
  • proanthocyanidins together with other condensed flavonoids have been shown to have therapeutic effects due to their powerful antioxidant activities.
  • the proanthocyanidin is provided within the composition as a pine bark extract. More preferably, the proanthocyanidin is provided within the composition as Pinus radiata pine bark extract.
  • the composition includes between 10 to 300 mg of proanthocyanidin or pine bark extract per dosage.
  • the composition includes about 25 to 150 mg proanthocyanidin or pine bark extract per dosage. Most preferably the composition includes about 75 mg proanthocyanidin or pine bark extract per dosage
  • the concentration of proanthocyanidin or pine bark extract in the composition is above 0.005% w/v, more preferably between 0.01 to 0.1 % w/v, and most preferably about 0.06% w/v.
  • the pine bark extract can cause problems with the taste profile of the composition.
  • the Applicant points out this can often be overcome by using masking agents, if required.
  • EGCG epigallocatechin gallate
  • ECG epicatechin gallate
  • EC epicatechin
  • EGCG accounts for about 50-80% of the catechins in green tea.
  • Catechins may also be found from other sources such as cocoa.
  • Green tea and/or its bioactives have been associated with many therapeutic effects, including cancer treatment, improved kidney function, diabetes, reducing hyperglycemia, reduction of Cortisol production, reduction in inflammation, and cardiovascular health.
  • cancer treatment includes cancer treatment, improved kidney function, diabetes, reducing hyperglycemia, reduction of Cortisol production, reduction in inflammation, and cardiovascular health.
  • catechins may impart some improvements in cognitive performance, but more understanding is required to establish a definitive mode of action or correlation.
  • the Applicant's research has found that when a green tea extract (and in particular, EGCG or other catechins) is combined specifically with L-theanine and proanthocyanidins, preliminary experiments suggest remarkable results in terms of improved mental clarity beyond which might have been expected from the individual components alone or when combined.
  • the composition includes between 50 to 600 mg of EGCG or green tea extract per dosage.
  • the composition includes about 100 - 300 mg EGCG or green tea extract per dosage.
  • the composition includes about 160 mg EGCG or green tea extract per dosage.
  • the concentration of EGCG or green tea extract is above 0.005% w/v, more preferably between 0.01 to 0.5 % w/v, and most preferably about 0.12 % w/v.
  • the composition includes: a) L-theanine between 0.015 to 0.17 % w/v, and most preferably about 0.08% w/v; b) a pine bark extract between 0.01 to 0.1 % w/v, and most preferably about 0.06% w/v; and c) a green tea extract between 0.01 to 0.5 % w/v, and most preferably about 0.12 % w/v.
  • the composition also includes anthocyanin.
  • Anthocyanins are members of the flavonoid group of phytochemicals often present in berryfruit (amongst other foods), and are most often responsible for imparting a deep red/purple/blue pigment to the fruit.
  • the composition includes between about 100 mg to 500 mg berryfruit extract per dosage, or most preferably about 500 mg per dosage.
  • the composition includes about 0.2 % w/v berryfruit extract.
  • the composition is caffeine free.
  • a significant advantage of the composition is that it does not rely on any need for a caffeine to provide the beneficial mental clarity effects, and avoids the jitteriness or anxiety associated with caffeine.
  • the composition includes no added sugar.
  • the composition may include a variety of excipients including natural flavours or fruit juice or concentrates; however a commercial advantage of the compositions developed is the lack of any need for added sugar to impart a pleasant tasting beverage.
  • the composition is used to treat, prevent, maintain or improve mental clarity for a period of time after consumption.
  • the composition may be used to: lower levels of tension / anxiety (or sub-sets of that such as nervousness); or lower levels of confusion / bewilderment (or sub-sets of that such as uncertainty); or improve levels of vigor activity (or sub-sets of that such as feeling lively, but without the jittery feeling often attributed from caffeine or other stimulants); or prevent feelings of depression or fatigue; or combinations thereof.
  • composition is used to treat, prevent, maintain or improve a healthy person's level of stress, mood, or sense of calmness.
  • Fig 4. Effects of Placebo and Product on the word Lively (included in the Vigor— Activity domain). Error bars denote ⁇ SE.
  • Fig 7. Mean effect of Placebo and Product on reaction time to Endogenous cues. Error bars denote ⁇ SE. Panel A - Prod uct*Cue Interaction.
  • Example 2 Functional beverage containing base composition
  • Pinus radiata bark extract 0.6 Grams (Enzogenol ® )
  • Example 3 Functional beverage containing base composition and blackcurrant extract
  • EXAMPLE 4 DOUBLE-BUND PLACEBO CONTOLLED CROSS OVER STU DY IN H UMANS
  • the plant extracts (or a cellulose placebo) were ingested in capsule form because the distinctive taste qualities of these extracts made it challenging to formulate a taste-matched placebo solution.
  • Each treatment was ingested alongside 250ml of the product's juice base. Participants underwent a mood assessment three times per trial, visual tests twice, and neurocognitive testing 30 minutes after consuming each test drink + capsules.
  • the test beverage had no detectable improvement effects on overall cognitive performance measured via the cognitive test battery. Yet, beneficially, there was no decrease in cognitive performance. However, also unexpectedly, there was a dramatic effect on mental clarity, and in particular an ability to process invalid ques, an increase in the vigour-activity domain, a decrease in anxiety domain, and/or a decrease in the confusion-bewilderment domain, particularly in the post- drink and extending somewhat after post-test time-points. These unexpected attributes are seen to be a major commercially important outcome. For example, consumers may feel a sense of vigour without the nervous / jitteriness feelings associated with other drinks such as those containing caffeine.
  • a Product and Placebo treatment were administered within a double-blind placebo-controlled randomised crossover design. Healthy adults visited the laboratory on two occasions, each visit was separated by 7 days. The trial order was block randomised with participants has equal probability of receiving both treatment orders. A fixed block size was used for stratification of participant sex.
  • Capsules contained either plant extracts or cellulose. This approach was taken because the distinctive taste qualities of the plant extracts made it challenging for the funder to formulate a taste-matched placebo solution within appropriate sensory discrimination thresholds.
  • the Product capsules contained 75mg of pine bark extract (Enzogenol) and 160mg of green tea extracts; min. 94% EGCG) and 100 mg L-theanine.
  • the Placebo capsules contained 335mg of a cellulose filler. All ingredients were licensed by NZ Food Safety authorities and will be combined and packaged in a licensed commercial facility (ENZO Nutraceuticals Quality Control Laboratory). Capsules and the fruit juice base were stored at 4°C and consumed within a research kitchen (University of Auckland, Building 731.120, Tamaki Campus).
  • the cognitive test battery comprised seven tests: verbal and visual memory, finger tapping, symbol digit coding, the Stroop test, a test of shifting attention, and a continuous performance test. A detailed description of each test is given by Gualtieri and Johnson (2006). Standardised computer instructions on how to complete each test were given before the test along with practice sessions when necessary. Tests were conducted in an environmentally-controlled and sound-proofed chamber. Tests were initiated and supervised (via a viewing window) by an experimenter and delivered unassisted and uninterrupted.
  • Test scoring was generated from 17 primary scores based on correct responses, error responses, number of responses, and reaction times.
  • Primary scores were used to generate nine neurocognitive domain scores to reflect basic mental functions (composite memory, verbal memory, visual memory, processing speed, executive function, psychomotor speed, reaction time, complex attention, and cognitive flexibility) and an overall neurocognitive index score.
  • Domain scores were generated as raw scores, calculated from composite primary scores of relevant tests, and then computed to standard scores and percentiles that represent the participants' raw score relative to an age-matched normative data set of healthy individuals. Standardized domain scores and the 17 primary scores were used for statistical analysis.
  • the POMS-SF is inventory that measures psychological distress via mood disturbance scores using a 30 word list of words. Each adjective is rated from 0-4 in terms of how the participant feels in the present moment; 0 - not at all, 1 - a little, 2 - moderately, 3 - quite a bit, and 4 - extremely. Each word falls under one of five domains; Depression, Vigor-Activity, Tension-Anxiety, Confusion-Bewilderment, or Fatigue. The scores given to the words that fall within each domain are then combined for an overall score.
  • the POMS-SF was administered three times during the protocol, at Baseline, 30 min Post-Drink, and Post-Test, along with the perceptual scales.
  • the initial baseline display consisted of a central fixation cross and two peripheral boxes.
  • the instruction was to maintain fixated on the central cross at all times while responding as quickly and accurately as possible upon perception of a circular target appearing within one of the peripheral boxes. Participants responded using the left or right arrow keys on the keyboard.
  • a cue was presented for 200 ms. The cue was either Endogenous (an arrow pointing to the right or left box), or Exogenous (an increase in the line width of the left or right box).
  • Valid trials consisted of the target appearing in the cued direction, whereas for Invalid trials the target appeared opposite to the cued location.
  • Neutral trials gave no indication as to where the target may appear, and were presented as a double-ended arrow in the endogenous trials, and an increase in the line width for both boxes in the exogenous trials.
  • 180 trials were collected, split evenly between endogenous and exogenous cues.
  • Valid, invalid and neutral trials were then randomised within the endogenous and exogenous blocks.
  • Keyboard responses were collected using customised Matlab software (MathWorks R2010b, Massachusettes, USA). To ensure that participants maintained fixation on the central cross, eye movements were monitored with a head-fixed eye tracking system (Viewpoint Eye Tracker, Arrington Research Systems, Scottsdale, USA). Any trials in which the eyes deviated were rejected from analysis. Participants completed the covert attention task at baseline and again Post-Test, after the cognitive test battery.
  • Paired t-tests were used to compare the time taken to complete the cognitive test battery, alertness rating score, and all results for each individual test and subsequent domains. A missing data analysis was required for one missing data point in the alertness rating score for a participant in their Product trial. This took the mean value for the rest of the group, rounded to the nearest whole number.
  • post-drink outcomes are considered to be more important than post-test outcomes as the post-drink is considered to be what primes the consumer to perform their daily tasks after consumption and act with mental clarity.
  • product group also importantly showed greater ability to quickly dispense with invalid cues, and be more balanced in terms of time taken to assess valid and invalid cues, both considered to be attributes of mental clarity.
  • the invention may also be said broadly to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, in any or all combinations of two or more of said parts, elements or features.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP17799731.9A 2016-05-17 2017-05-11 Zusammensetzungen mit l-theanin, proanthocyanidin und catechin sowie verwendungen davon Withdrawn EP3461260A4 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NZ16720245 2016-05-17
PCT/NZ2017/050058 WO2017200391A1 (en) 2016-05-17 2017-05-11 Compositions comprising l-theanine, proanthocyanidin/s and a catechin and uses thereof

Publications (2)

Publication Number Publication Date
EP3461260A1 true EP3461260A1 (de) 2019-04-03
EP3461260A4 EP3461260A4 (de) 2020-02-12

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP17799731.9A Withdrawn EP3461260A4 (de) 2016-05-17 2017-05-11 Zusammensetzungen mit l-theanin, proanthocyanidin und catechin sowie verwendungen davon

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Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ540257A (en) * 2005-05-23 2008-06-30 Mathias Alfons Everhard Frevel Cognitive abilities improving agent obtained from Pinus bark
MX2008012065A (es) * 2006-03-23 2008-10-07 Herbalscience Singapore Pte Ltd Extractos y metodos que comprenden especies de te verde.
US20070248696A1 (en) * 2006-04-25 2007-10-25 Mind Sports Nutrition Inc. Composition and method for enhancing neuromuscular facilitation and cognitive functions
JP2011168523A (ja) * 2010-02-18 2011-09-01 Toyo Shinyaku Co Ltd 月経前症候群に起因する症状緩和剤およびその症状緩和剤を含有する飲食品
CN104432063B (zh) * 2014-12-18 2017-02-01 北京康比特体育科技股份有限公司 一种缓解运动性疲劳的组合物及其制剂

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