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Effectiveness of Enriched Milk with Ashwagandha Extract and Tryptophan for Improving Subjective Sleep Quality in Adults with Sleep Problems: A Randomized Double-Blind Controlled Trial
A randomized, double-blind and controlled study was conducted to assess the effectiveness of the intake of 250 mL of lactose-free skimmed milk enriched with ashwagandha ( ) alone or combined with tryptophan vs. non-enriched milk (control) on the subjective quality of sleep in healthy adults with sle...
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Published in: | Clocks & Sleep (Online) 2024-08, Vol.6 (3), p.417-432 |
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creator | Pérez-Piñero, Silvia Muñoz-Carrillo, Juan Carlos Echepare-Taberna, Jon Muñoz-Cámara, Macarena Herrera-Fernández, Cristina Ávila-Gandía, Vicente Heres Fernández Ladreda, María Menéndez Martínez, Javier López-Román, Francisco Javier |
description | A randomized, double-blind and controlled study was conducted to assess the effectiveness of the intake of 250 mL of lactose-free skimmed milk enriched with ashwagandha (
) alone or combined with tryptophan vs. non-enriched milk (control) on the subjective quality of sleep in healthy adults with sleep problems. The duration of supplementation was 90 days. Fifty-two eligible subjects were assigned to the study arms of ashwagandha 250 mg, ashwagandha 250 mg plus tryptophan 175 mg, ashwagandha 600 mg, and control with 13 subjects in each group. It was hypothesized that ashwagandha plus tryptophan could be superior to ashwagandha alone for improving sleep-related variables. Changes in the visual analogue scale (VAS) for sleep quality were significantly higher in the three experimental groups as compared with controls (
= 0.014). Improvements in the subscales of the Pittsburg Sleep Quality Index (PSQI) were found in all groups, but between-group differences were not significant. In the index of insomnia severity, decreases were higher in the three experimental groups as compared with controls especially in the group of ashwagandha 600 mg. Daytime somnolence was also reduced in the three experimental groups. Changes in anxiety levels and Morningness-Eveningness Questionnaire were not observed. The study products did not elicit changes in body composition and were well tolerated and safe. The data did not support the hypothesis, as the combination of ashwagandha and tryptophan did not show greater benefits in improving sleep quality than ashwagandha alone. However, the results from the three experimental groups containing ashwagandha were more favorable compared to the placebo group. |
doi_str_mv | 10.3390/clockssleep6030028 |
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) alone or combined with tryptophan vs. non-enriched milk (control) on the subjective quality of sleep in healthy adults with sleep problems. The duration of supplementation was 90 days. Fifty-two eligible subjects were assigned to the study arms of ashwagandha 250 mg, ashwagandha 250 mg plus tryptophan 175 mg, ashwagandha 600 mg, and control with 13 subjects in each group. It was hypothesized that ashwagandha plus tryptophan could be superior to ashwagandha alone for improving sleep-related variables. Changes in the visual analogue scale (VAS) for sleep quality were significantly higher in the three experimental groups as compared with controls (
= 0.014). Improvements in the subscales of the Pittsburg Sleep Quality Index (PSQI) were found in all groups, but between-group differences were not significant. In the index of insomnia severity, decreases were higher in the three experimental groups as compared with controls especially in the group of ashwagandha 600 mg. Daytime somnolence was also reduced in the three experimental groups. Changes in anxiety levels and Morningness-Eveningness Questionnaire were not observed. The study products did not elicit changes in body composition and were well tolerated and safe. The data did not support the hypothesis, as the combination of ashwagandha and tryptophan did not show greater benefits in improving sleep quality than ashwagandha alone. However, the results from the three experimental groups containing ashwagandha were more favorable compared to the placebo group.</description><identifier>ISSN: 2624-5175</identifier><identifier>EISSN: 2624-5175</identifier><identifier>DOI: 10.3390/clockssleep6030028</identifier><identifier>PMID: 39189195</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Adults ; Anxiety ; ashwagandha ; Benzodiazepines ; Clinical trials ; Comparative analysis ; dietary supplementation ; Drug dosages ; Health care ; Insomnia ; Melatonin ; Mental disorders ; Milk ; Performance evaluation ; Physiological aspects ; Quality management ; Questionnaires ; Sleep ; sleep disorders ; sleep quality ; Systematic review ; Tryptophan</subject><ispartof>Clocks & Sleep (Online), 2024-08, Vol.6 (3), p.417-432</ispartof><rights>COPYRIGHT 2024 MDPI AG</rights><rights>2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2024 by the authors. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c445t-64624532ca5365982220374635a95af28888e7bce097a54e74a6f7e68ab333f43</cites><orcidid>0000-0002-2841-5502 ; 0009-0002-4347-695X ; 0000-0002-5874-7508 ; 0000-0002-2027-9075 ; 0000-0002-0294-6663 ; 0000-0002-8151-0576</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/3110432110/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/3110432110?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,37013,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39189195$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pérez-Piñero, Silvia</creatorcontrib><creatorcontrib>Muñoz-Carrillo, Juan Carlos</creatorcontrib><creatorcontrib>Echepare-Taberna, Jon</creatorcontrib><creatorcontrib>Muñoz-Cámara, Macarena</creatorcontrib><creatorcontrib>Herrera-Fernández, Cristina</creatorcontrib><creatorcontrib>Ávila-Gandía, Vicente</creatorcontrib><creatorcontrib>Heres Fernández Ladreda, María</creatorcontrib><creatorcontrib>Menéndez Martínez, Javier</creatorcontrib><creatorcontrib>López-Román, Francisco Javier</creatorcontrib><title>Effectiveness of Enriched Milk with Ashwagandha Extract and Tryptophan for Improving Subjective Sleep Quality in Adults with Sleep Problems: A Randomized Double-Blind Controlled Trial</title><title>Clocks & Sleep (Online)</title><addtitle>Clocks Sleep</addtitle><description>A randomized, double-blind and controlled study was conducted to assess the effectiveness of the intake of 250 mL of lactose-free skimmed milk enriched with ashwagandha (
) alone or combined with tryptophan vs. non-enriched milk (control) on the subjective quality of sleep in healthy adults with sleep problems. The duration of supplementation was 90 days. Fifty-two eligible subjects were assigned to the study arms of ashwagandha 250 mg, ashwagandha 250 mg plus tryptophan 175 mg, ashwagandha 600 mg, and control with 13 subjects in each group. It was hypothesized that ashwagandha plus tryptophan could be superior to ashwagandha alone for improving sleep-related variables. Changes in the visual analogue scale (VAS) for sleep quality were significantly higher in the three experimental groups as compared with controls (
= 0.014). Improvements in the subscales of the Pittsburg Sleep Quality Index (PSQI) were found in all groups, but between-group differences were not significant. In the index of insomnia severity, decreases were higher in the three experimental groups as compared with controls especially in the group of ashwagandha 600 mg. Daytime somnolence was also reduced in the three experimental groups. Changes in anxiety levels and Morningness-Eveningness Questionnaire were not observed. The study products did not elicit changes in body composition and were well tolerated and safe. The data did not support the hypothesis, as the combination of ashwagandha and tryptophan did not show greater benefits in improving sleep quality than ashwagandha alone. However, the results from the three experimental groups containing ashwagandha were more favorable compared to the placebo group.</description><subject>Adults</subject><subject>Anxiety</subject><subject>ashwagandha</subject><subject>Benzodiazepines</subject><subject>Clinical trials</subject><subject>Comparative analysis</subject><subject>dietary supplementation</subject><subject>Drug dosages</subject><subject>Health care</subject><subject>Insomnia</subject><subject>Melatonin</subject><subject>Mental disorders</subject><subject>Milk</subject><subject>Performance evaluation</subject><subject>Physiological aspects</subject><subject>Quality management</subject><subject>Questionnaires</subject><subject>Sleep</subject><subject>sleep disorders</subject><subject>sleep quality</subject><subject>Systematic review</subject><subject>Tryptophan</subject><issn>2624-5175</issn><issn>2624-5175</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNptkttuEzEQhlcIRKvSF-ACWeKGmxQf98ANCiFApCIOLdeW1zvOOvWug72bEl6M18MhpTSALXnt8T_feGYnyx4TfMZYhZ9r5_VVjA5gnWOGMS3vZcc0p3wiSCHu39kfZacxrnCSCMyrgj3MjlhFyopU4jj7MTcG9GA30EOMyBs074PVLTTovXVX6NoOLZrG9lotVd-0Cs2_DUHpAaUTugzb9eDXreqR8QEtunXwG9sv0cVYr_ZUdLF7Ifo0KmeHLbI9mjajG-IevL_8GHztoIsv0BR9Tlzf2e8p_ms_JvPklbMp1Mz3Q_DOwS6qVe5R9sAoF-H05nuSfXkzv5y9m5x_eLuYTc8nmnMxTHKeqiAY1UqwXFQlpRSzgudMqEooQ8s0oKg14KpQgkPBVW4KyEtVM8YMZyfZYs9tvFrJdbCdClvplZW_DD4spQqD1Q6k5oUwWhcV1Jo3jNRaUMYwLQBKUIVJrJd71nqsO2g0pJSUO4Ae3vS2lUu_kYQwXlJSJMKzG0LwX0eIg-xs1OCc6sGPUbKUBq94yXbSp39JV34MfaqVZIRgzmha_6iWKmVge-N3f3cHldOS4LzCWJCkOvuPKs0GOqt9D8Ym-4ED3Tvo4GMMYG6TJFju2lf-277J6cnd8ty6_G5W9hOG1u9F</recordid><startdate>20240809</startdate><enddate>20240809</enddate><creator>Pérez-Piñero, Silvia</creator><creator>Muñoz-Carrillo, Juan Carlos</creator><creator>Echepare-Taberna, Jon</creator><creator>Muñoz-Cámara, Macarena</creator><creator>Herrera-Fernández, Cristina</creator><creator>Ávila-Gandía, Vicente</creator><creator>Heres Fernández Ladreda, María</creator><creator>Menéndez Martínez, Javier</creator><creator>López-Román, Francisco Javier</creator><general>MDPI AG</general><general>MDPI</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M2M</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-2841-5502</orcidid><orcidid>https://orcid.org/0009-0002-4347-695X</orcidid><orcidid>https://orcid.org/0000-0002-5874-7508</orcidid><orcidid>https://orcid.org/0000-0002-2027-9075</orcidid><orcidid>https://orcid.org/0000-0002-0294-6663</orcidid><orcidid>https://orcid.org/0000-0002-8151-0576</orcidid></search><sort><creationdate>20240809</creationdate><title>Effectiveness of Enriched Milk with Ashwagandha Extract and Tryptophan for Improving Subjective Sleep Quality in Adults with Sleep Problems: A Randomized Double-Blind Controlled Trial</title><author>Pérez-Piñero, Silvia ; Muñoz-Carrillo, Juan Carlos ; Echepare-Taberna, Jon ; Muñoz-Cámara, Macarena ; Herrera-Fernández, Cristina ; Ávila-Gandía, Vicente ; Heres Fernández Ladreda, María ; Menéndez Martínez, Javier ; López-Román, Francisco Javier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c445t-64624532ca5365982220374635a95af28888e7bce097a54e74a6f7e68ab333f43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adults</topic><topic>Anxiety</topic><topic>ashwagandha</topic><topic>Benzodiazepines</topic><topic>Clinical trials</topic><topic>Comparative analysis</topic><topic>dietary supplementation</topic><topic>Drug dosages</topic><topic>Health care</topic><topic>Insomnia</topic><topic>Melatonin</topic><topic>Mental disorders</topic><topic>Milk</topic><topic>Performance evaluation</topic><topic>Physiological aspects</topic><topic>Quality management</topic><topic>Questionnaires</topic><topic>Sleep</topic><topic>sleep disorders</topic><topic>sleep quality</topic><topic>Systematic review</topic><topic>Tryptophan</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pérez-Piñero, Silvia</creatorcontrib><creatorcontrib>Muñoz-Carrillo, Juan Carlos</creatorcontrib><creatorcontrib>Echepare-Taberna, Jon</creatorcontrib><creatorcontrib>Muñoz-Cámara, Macarena</creatorcontrib><creatorcontrib>Herrera-Fernández, Cristina</creatorcontrib><creatorcontrib>Ávila-Gandía, Vicente</creatorcontrib><creatorcontrib>Heres Fernández Ladreda, María</creatorcontrib><creatorcontrib>Menéndez Martínez, Javier</creatorcontrib><creatorcontrib>López-Román, Francisco Javier</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Psychology Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>Clocks & Sleep (Online)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pérez-Piñero, Silvia</au><au>Muñoz-Carrillo, Juan Carlos</au><au>Echepare-Taberna, Jon</au><au>Muñoz-Cámara, Macarena</au><au>Herrera-Fernández, Cristina</au><au>Ávila-Gandía, Vicente</au><au>Heres Fernández Ladreda, María</au><au>Menéndez Martínez, Javier</au><au>López-Román, Francisco Javier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness of Enriched Milk with Ashwagandha Extract and Tryptophan for Improving Subjective Sleep Quality in Adults with Sleep Problems: A Randomized Double-Blind Controlled Trial</atitle><jtitle>Clocks & Sleep (Online)</jtitle><addtitle>Clocks Sleep</addtitle><date>2024-08-09</date><risdate>2024</risdate><volume>6</volume><issue>3</issue><spage>417</spage><epage>432</epage><pages>417-432</pages><issn>2624-5175</issn><eissn>2624-5175</eissn><abstract>A randomized, double-blind and controlled study was conducted to assess the effectiveness of the intake of 250 mL of lactose-free skimmed milk enriched with ashwagandha (
) alone or combined with tryptophan vs. non-enriched milk (control) on the subjective quality of sleep in healthy adults with sleep problems. The duration of supplementation was 90 days. Fifty-two eligible subjects were assigned to the study arms of ashwagandha 250 mg, ashwagandha 250 mg plus tryptophan 175 mg, ashwagandha 600 mg, and control with 13 subjects in each group. It was hypothesized that ashwagandha plus tryptophan could be superior to ashwagandha alone for improving sleep-related variables. Changes in the visual analogue scale (VAS) for sleep quality were significantly higher in the three experimental groups as compared with controls (
= 0.014). Improvements in the subscales of the Pittsburg Sleep Quality Index (PSQI) were found in all groups, but between-group differences were not significant. In the index of insomnia severity, decreases were higher in the three experimental groups as compared with controls especially in the group of ashwagandha 600 mg. Daytime somnolence was also reduced in the three experimental groups. Changes in anxiety levels and Morningness-Eveningness Questionnaire were not observed. The study products did not elicit changes in body composition and were well tolerated and safe. The data did not support the hypothesis, as the combination of ashwagandha and tryptophan did not show greater benefits in improving sleep quality than ashwagandha alone. However, the results from the three experimental groups containing ashwagandha were more favorable compared to the placebo group.</abstract><cop>Switzerland</cop><pub>MDPI AG</pub><pmid>39189195</pmid><doi>10.3390/clockssleep6030028</doi><tpages>16</tpages><orcidid>https://orcid.org/0000-0002-2841-5502</orcidid><orcidid>https://orcid.org/0009-0002-4347-695X</orcidid><orcidid>https://orcid.org/0000-0002-5874-7508</orcidid><orcidid>https://orcid.org/0000-0002-2027-9075</orcidid><orcidid>https://orcid.org/0000-0002-0294-6663</orcidid><orcidid>https://orcid.org/0000-0002-8151-0576</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adults Anxiety ashwagandha Benzodiazepines Clinical trials Comparative analysis dietary supplementation Drug dosages Health care Insomnia Melatonin Mental disorders Milk Performance evaluation Physiological aspects Quality management Questionnaires Sleep sleep disorders sleep quality Systematic review Tryptophan |
title | Effectiveness of Enriched Milk with Ashwagandha Extract and Tryptophan for Improving Subjective Sleep Quality in Adults with Sleep Problems: A Randomized Double-Blind Controlled Trial |
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