Enhancement of Sleep Quality and Mood Following Supplementation With Lemon Balm in an Adult Population (Lemslp)

NCT05422599 | Completed

• 1 other identifier: 22/01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of a 4-week dietary intervention of 300mg encapsulated aqueous lemon balm extract on measures of sleep quality, mood and well-being, alongside relevant biomarkers of circadian rhythms in healthy adults aged 18-40 years with mild sleep problems (PSQI entry of 5 and above). Three visits to the university alongside completing some home tests involving self-test stool, saliva and mood tests and wearing an wrist-secured actiwatch over 4-weeks whilst recording a daily sleep diary will be monitored to estimate sleep changes. Mood ratings, stool and saliva biomarkers will serve as a proxy to sleep improvement.

Conditions

Sleep Disturbance; Mood Disturbance

Keywords

Sleep Quality, Sleep Onset Latency, Sleep Duration; Lemon Balm, Melissa Officinalis, Herbal Psychotropic; Sleep Diaries, Actiwatches, PSQI, Gut-Brain Axis Microbiota; Wellbeing, Antidepressant, Anxiolytic, Cognitive-Enhancing; Salivary Analytes, Melatonin, Cortisol

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  A validated measure of sleep assessing qualities and patterns within the last month of sleep habits in adults. Seven components of sleep (quality, latency, duration, efficiency, disturbance, use of sleep medication, daytime dysfunction) will be summed to achieve a global PSQI score ranging from 0 to 21 points, where scores above 5 indicates sleep problems.

  4 weeks

Secondary Outcomes (13)

• Combined Sleep Diary and Research-Grade Actiwatch Sleep-Wake Patterns

  Continuous over 4 weeks

• Diurnal Salivary Cortisol and Melatonin Patterns

  4 weeks

• Gut Microbiota Changes

  4 weeks

• Insomnia Severity Index (ISI)

  4 weeks

• Leeds Sleep Evaluation Questionnaire (LSEQ)

  4 weeks

Study Arms (2)

Lemon balm

EXPERIMENTAL

300mg Lemon balm and Maltodextrin

Dietary Supplement: Lemon balm

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Lemon balm DIETARY_SUPPLEMENT

300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L.

Lemon balm

Placebo DIETARY_SUPPLEMENT

300mg Maltodextrin capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, between18-40 years old
• Mild Sleep problems (PSQI less than or equal to 5)
• Willingness to provide stool and saliva samples, wear an actiwatch and complete a nightly sleep diary.

You may not qualify if:

• Use medications that may affect the outcome
• Any long-term psychological or physiological health conditions
• Have any allergic reactions to ingredients in the capsules
• Have a BMI greater than or equal to 30
• Are vegetarian
• Taking any dietary supplements which they are unwilling to stop for the duration of the study

Sponsors & Collaborators

• University of Reading: lead
• Naturex: collaborator

Study Sites (1)

School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Related Publications (15)

• Scholey A, Gibbs A, Neale C, Perry N, Ossoukhova A, Bilog V, Kras M, Scholz C, Sass M, Buchwald-Werner S. Anti-stress effects of lemon balm-containing foods. Nutrients. 2014 Oct 30;6(11):4805-21. doi: 10.3390/nu6114805.

  PMID: 25360512 BACKGROUND

• Araj-Khodaei M, Noorbala AA, Yarani R, Emadi F, Emaratkar E, Faghihzadeh S, Parsian Z, Alijaniha F, Kamalinejad M, Naseri M. A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression. BMC Complement Med Ther. 2020 Jul 3;20(1):207. doi: 10.1186/s12906-020-03003-5.

  PMID: 32620104 BACKGROUND

• Kennedy DO, Scholey AB, Tildesley NT, Perry EK, Wesnes KA. Modulation of mood and cognitive performance following acute administration of Melissa officinalis (lemon balm). Pharmacol Biochem Behav. 2002 Jul;72(4):953-64. doi: 10.1016/s0091-3057(02)00777-3.

  PMID: 12062586 BACKGROUND

• Haybar H, Javid AZ, Haghighizadeh MH, Valizadeh E, Mohaghegh SM, Mohammadzadeh A. The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina. Clin Nutr ESPEN. 2018 Aug;26:47-52. doi: 10.1016/j.clnesp.2018.04.015. Epub 2018 May 19.

  PMID: 29908682 BACKGROUND

• Ghazizadeh J, Hamedeyazdan S, Torbati M, Farajdokht F, Fakhari A, Mahmoudi J, Araj-Khodaei M, Sadigh-Eteghad S. Melissa officinalis L. hydro-alcoholic extract inhibits anxiety and depression through prevention of central oxidative stress and apoptosis. Exp Physiol. 2020 Apr;105(4):707-720. doi: 10.1113/EP088254. Epub 2020 Feb 21.

  PMID: 32003913 BACKGROUND

• Noguchi-Shinohara M, Ono K, Hamaguchi T, Iwasa K, Nagai T, Kobayashi S, Nakamura H, Yamada M. Pharmacokinetics, Safety and Tolerability of Melissa officinalis Extract which Contained Rosmarinic Acid in Healthy Individuals: A Randomized Controlled Trial. PLoS One. 2015 May 15;10(5):e0126422. doi: 10.1371/journal.pone.0126422. eCollection 2015.

  PMID: 25978046 BACKGROUND

• Buysse DJ, Hall ML, Strollo PJ, Kamarck TW, Owens J, Lee L, Reis SE, Matthews KA. Relationships between the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and clinical/polysomnographic measures in a community sample. J Clin Sleep Med. 2008 Dec 15;4(6):563-71.

  PMID: 19110886 BACKGROUND

• Rivest RW, Schulz P, Lustenberger S, Sizonenko PC. Differences between circadian and ultradian organization of cortisol and melatonin rhythms during activity and rest. J Clin Endocrinol Metab. 1989 Apr;68(4):721-9. doi: 10.1210/jcem-68-4-721.

  PMID: 2921307 BACKGROUND

• Carlson LE, Campbell TS, Garland SN, Grossman P. Associations among salivary cortisol, melatonin, catecholamines, sleep quality and stress in women with breast cancer and healthy controls. J Behav Med. 2007 Feb;30(1):45-58. doi: 10.1007/s10865-006-9082-3. Epub 2007 Jan 24.

  PMID: 17245618 BACKGROUND

• Chang WP, Lin CC. Relationships of salivary cortisol and melatonin rhythms to sleep quality, emotion, and fatigue levels in patients with newly diagnosed lung cancer. Eur J Oncol Nurs. 2017 Aug;29:79-84. doi: 10.1016/j.ejon.2017.05.008. Epub 2017 Jun 2.

  PMID: 28720269 BACKGROUND

• Ibarra A, Feuillere N, Roller M, Lesburgere E, Beracochea D. Effects of chronic administration of Melissa officinalis L. extract on anxiety-like reactivity and on circadian and exploratory activities in mice. Phytomedicine. 2010 May;17(6):397-403. doi: 10.1016/j.phymed.2010.01.012. Epub 2010 Feb 18.

  PMID: 20171069 RESULT

• Cases J, Ibarra A, Feuillere N, Roller M, Sukkar SG. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition Metab. 2011 Dec;4(3):211-218. doi: 10.1007/s12349-010-0045-4. Epub 2010 Dec 17.

  PMID: 22207903 RESULT

• Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.

  PMID: 22294820 RESULT

• Orchard F, Gregory AM, Gradisar M, Reynolds S. Self-reported sleep patterns and quality amongst adolescents: cross-sectional and prospective associations with anxiety and depression. J Child Psychol Psychiatry. 2020 Oct;61(10):1126-1137. doi: 10.1111/jcpp.13288. Epub 2020 Jun 17.

  PMID: 32557672 RESULT

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 RESULT

Related Links

• WHO (2002). World Health Organisation monographs on selected medicinal plants, Vol 2.
• Givaudan Vivascentz Wellbeing Metric

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Interventions

lemon balm leaf extract

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Claire M Williams, Professor

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Neuroscience

Model Details: Between and within groups model

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: May 5, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

GB (1)