ORALLY INGESTED COMPOSITION FOR IMPROVING SLEEP
20220133674 · 2022-05-05
Inventors
Cpc classification
A61K36/899
HUMAN NECESSITIES
A23L33/105
HUMAN NECESSITIES
A61K9/0053
HUMAN NECESSITIES
A61K36/81
HUMAN NECESSITIES
A61K31/221
HUMAN NECESSITIES
A61K9/0056
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K2300/00
HUMAN NECESSITIES
A61K36/899
HUMAN NECESSITIES
International classification
A61K31/221
HUMAN NECESSITIES
A61K36/81
HUMAN NECESSITIES
A61K36/899
HUMAN NECESSITIES
A61K9/00
HUMAN NECESSITIES
Abstract
The present invention addresses the problem of providing a novel orally ingested composition that contains a substance which is not conventionally known as an active component of a composition for improving sleep, and particularly, that can be easily taken orally and can improve sleep safely and easily. The present invention pertains to an orally ingested composition, particularly a food composition, for improving sleep and containing a choline ester as an active component In the present invention, the choline ester may be derived from an edible plant such as the fruit of the species Solanum melongena of the genus Solanum of the family Solanaceae and/or the green shoot of the tribe Bambuseae of the subfamily Bambusoideae of the family Poaceae.
Claims
1. A method for improving sleep comprising orally administrating a composition comprising a choline ester as an effective ingredient to a subject.
2. The method according to claim 1, wherein the composition is a food composition.
3. The method according to claim 1, wherein the choline ester is derived from a food plant.
4. The method according to claim 3, wherein the food plant is a fruit of the family Solanaceae, the genus Solanum, the species Solanum melongena and/or a young bud of the family Poaceae, the subfamily Bambusoideae, the tribe Bambuseae.
5. The method according to claim 1, wherein the choline ester comprises one or more selected from the group consisting of acetylcholine, butylcholine and propionylcholine.
6. The method according to claim 5, wherein the choline ester does not comprise lactoylcholine.
7. The method according to claim 1, wherein daily intake of the choline ester is between 7.5 μg and 750 mg.
8. The method according to claim 1, wherein the improving sleep is an increase in sleeping time.
Description
EXAMPLES
[0061] 1. Test and placebo foods [0062] (1) Preparation of the test food (choline ester-containing composition)
[0063] Harvested aubergines were heat-sterilized (90° C., 10 min), subsequently extracted to yield juice, to which an excipient (dextrin) was added at 25% to the weight of the extracted juice, freeze-dried to prepare a 25% dextrin-mixed aubergine freeze-dried powder. The functional ingredient in the 25% dextrin-mixed aubergine freeze-dried powder was quantified, and a predetermined weight of 300 mg was filled in an opaque capsule (made of hydroxypropylmethykellulose). The choline ester content per one capsule was 576 μg. [0064] (2) Preparation of the placebo food
[0065] An opaque capsule that was the same as the test food was filled with 280 mg of excipient (dextrin). [0066] 2. Subjects
[0067] The test food and placebo food were taken by 21 male and female subjects at the ages from 30's to 50's. [0068] 3. Electroencephalogram measurement and test food ingestion [0069] (1) Test period (schedule)
[0070] According to the schedule shown in Table 2, electroencephalogram was measured for 14 days. Ingestion of the test food and placebo food was carried out by crossover method of 10 days in total including 5 days of test food ingestion and 5 days of placebo food ingestion.
TABLE-US-00002 TABLE 2 Day 1 and Day 2 Electroencephalogram measurement only Day 3 to Day 7 Test or placebo food ingestion, and electroencephalogram measurement Day 8 and Day 9 Wash-out period (electroencephalogram measurement only) Day 10 to Day 14 Crossover of test or placebo food ingestion, and electroencephalogram measurement [0071] (2) Ingestion
[0072] 6 capsule a day of the test food (choline ester amount total 3456 μg/day) or placebo food were ingested with water or warm water from 30 minutes to 1 hour before turning in. Note that the subject is principally prohibited to take alcohol drink during the test period, and prohibited to take caffeine-containing drinks after dinner to turning in. Moreover, it was determined that aubergines and processed food thereof, bamboo shoots and processed food thereof, fermented foods derived from plant materials shall not be taken. [0073] (3) Electroencephalogram measurement
[0074] Electroencephalogram was measured by wearing a electroencephalograph (Tradename: SLEEPSCOPE (SleepWell)) during sleep. From the measurements from the first sleep cycle to the forth sleep cycle, average values were calculated for each item shown in Table 3. [0075] 4. Results
[0076] The results are shown in Table 3.
TABLE-US-00003 TABLE 3 Test food- Placebo food- ingested group ingested group (n = 63) (n = 63) t-test Measurement recording time 376.70 363.82 n.s. (TIB) (min) Sleeping latency (min) 17.142 15.356 n.s. non-REM deep sleeping 20.717 23.510 n.s. latency (min) REM sleeping latency (min) 66.640 66.864 n.s. Sleeping time (min) 356.01 341.88 * Total sleeping time (min) 328.02 315.32 * Stage-total time (non-REM 1) 68.568 62.500 * (min) Stage-total time (non-REM 2) 160.73 159.44 n.s. (min) Stage-total time (non-REM 3) 25.526 25.070 n.s. (min) Stage-total time (REM) (min) 66.798 66.698 n.s. Stage-total time (awake) (min) 26.863 25.734 n.s. *: P < 0.05; n.s.: non-significant [0077] 5. Consideration
[0078] As shown in Table 3, in the test food-ingested group, sleeping time was significantly increased as compared to the placebo food-ingested group. In particular, non-REM total time, which is an index of deep sleep was significantly increased. Because there was no significant difference in sleep efficiency, it became clear that the sleeping time was increased not due to a deterioration in the sleep efficiency, but sleep time could be increased while keeping the sleep efficiency. Moreover, increased percentage of deep sleep clarified an effect of improving sleep rhythm. By these effects, an improvement in sleep was recognized.
[0079] Moreover, an improved sleep efficiency, shortened sleep induction time, increased non-REM sleeping time or reduced nocturnal awakening can be expected by a method of food ingestion with reduced burden such as, for example, decreased number of capsules to be taken at once,
INDUSTRIAL APPLICABILITY
[0080] The composition of the present invention has a remarkable sleep-improving effect, and by including this as an active ingredient, a food with functional claims or a medicament for treating sleep disorder, etc. can be produced.