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

October 12, 2023 updated by: Prof Claire Williams, University of Reading

A Randomised Double-blind Placebo-controlled Trial on Encapsulated Lemon Balm Efficacy and Tolerance on Sleep Quality Changes, and Mood and Wellbeing Effects Using Objective and Subjective Measures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomised, double-blind, placebo-controlled, parallel-design study assessing the effect of a 4-week intervention of lemon balm extract (or matched placebo) in young to middle-age adults with mild sleep problems. A total of 108 participants will be randomly assigned to either 300 mg lemon balm extract or a matched placebo capsule consumed nightly before retiring to bed. The severity of sleep problems, depression, anxiety, perceived stress, quality of life and well-being will be measured at baseline and after 4 weeks of daily consumption. In addition, we will assess changes in microbiota and saliva neurohormone profiles at baseline and after 4 weeks of treatment.

Entry to the study to determine eligibility involves a sleep quality questionnaire (PSQI) score of 5 and above. The study comprises of a familiarisation visit and then two test days at the Nutritional Psychology Unit based at the University of Reading where primary sleep (PSQI), and exploratory measures of sleep (ISI, LSEQ) and mood (PANAS, Vivascentz(TM), FFS, PSS, DASS-21) tests will be completed. The screening visit will further assess habitual diet (Epic-Norfolk FFQ), and general health and lifestyle patterns to confirm eligibility. Participants will then continuously wear an wrist-secured actiwatch whilst recording a daily sleep diary to estimate sleep changes over the 4-week period. In addition, some further exploratory tests will be completed by participants from home 24h before baseline and 24h before post-intervention (saliva, stool, PANAS-X).

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AL
        • School of Psychology and Clinical Languages, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
300mg Maltodextrin capsules
Experimental: Lemon balm
300mg Lemon balm and Maltodextrin
Dietary supplement: Lemon balm
300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined Sleep Diary and Research-Grade Actiwatch Sleep-Wake Patterns
Time Frame: Continuous over 4 weeks
Passive motion tracking of sleep-wake patterns (heart rate variability) will be recorded via a wrist-worn research-grade actiwatch. The actiwatches will be secured on the participant's wrist throughout the study period. To cross-examine the actiwatch data, an in-house standardised daily sleep diary will measure sleep quality, sleep duration and sleep latency (how many times awoken during sleep time) (Carney et al., 2012; Orchard et al., 2020) where meaningful sleep outcomes will be manually inputted into actiwatch software at the end of sleep monitoring, as per standard practice in sleep research.
Continuous over 4 weeks
Diurnal Salivary Cortisol and Melatonin Patterns
Time Frame: 4 weeks
Determination of changes in circadian sleep-wake patterns after 4-weeks daily 300mg lemon balm treatment by assessing diurnal sleep neurohormones, melatonin and cortisol. Changes in melatonin and cortisol will be assessed using 12 salivary self-test sampling kits taken in two windows (6 samples per window), within 24h before baseline day and within 24h before post-intervention day. For each test day, two samples will be taken first thing in the morning, 11am, 5pm and a final two samples in the evening. Sleep neurohormones will then be assessed against subjective sleep scores.
4 weeks
Gut Microbiota Changes
Time Frame: 4 weeks
Examination of gut responses to mood and sleep physiology changes after 4-weeks daily 300mg lemon balm treatment by assessing changes in faecal microbiota levels. Two samples will be collected over the entire study. Microbiome diversity will be determined using self-test stool sampling kits taken in two windows, within 24h before baseline day and within 24h before post-intervention day. Faecal microbiota will then be compared to subjective sleep and mood scores.
4 weeks
Insomnia Severity Index (ISI)
Time Frame: 4 weeks
A validated 7-item instrument designed to assess the nature, severity and impact of both nighttime and daytime components of insomnia within the last month. The scale ranges from 0 to 28 where higher scores indicate more severe insomnia.
4 weeks
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: 4 weeks
A 10-item self-report slider scale to evaluate ease of getting to sleep, sleep quality, ease of waking and behaviour following wakefulness. Higher scores indicate better sleep quality.
4 weeks
Perceived Stress Scale (PSS)
Time Frame: 4 weeks
A validated 10-item questionnaire to measure levels of perceived stress. The scale ranges from 0 to 40 points with higher scores indicating greater stress levels.
4 weeks
Positive affect as measured by PANAS-X
Time Frame: 4 weeks
General positive affect for assessing trait mood over the past month will be calculated by adding the values of 10 positive items in correspondence with the original PANAS, ranging from 0-50 where higher scores indicate positive affect. In addition, the expanded Positive and Negative Affect Schedule-X will assess higher order scales Surprise, Joviality,Self-Assurance, Attentiveness, and Serenity and these collective scores combined with general positive affect range from 0 to 170 points, where higher scores indicate better mood.
4 weeks
Positive affect as measured by PANAS-NOW
Time Frame: 4 weeks
General positive affect for assessing transient mood as the respondent feels in the present moment will be calculated by adding the values of 10 positive items. Scores range from 0-50 points where higher scores indicate positive affect.
4 weeks
Negative affect as measured by PANAS-X
Time Frame: 4 weeks
General positive affect for assessing trait mood over the past month will be calculated by adding the values of 10 negative items in correspondence with the original PANAS, ranging from 0-50 where higher scores indicate negative affect. In addition, the expanded Positive and Negative Affect Schedule-X will assess higher order scales Fear, Sadness, Guilt, Hostility, Shyness, Fatigue and these collective scores combined with general negative affect range from 0 to 170 points, where higher scores indicate worse mood.
4 weeks
Negative affect as measured by PANAS-NOW
Time Frame: 4 weeks
General negative affect for assessing transient mood as the respondent feels in the present moment will be calculated by adding the values of 10 negative items, ranging from 0-50 where higher scores indicate negative affect.
4 weeks
Depression, Anxiety and Stress Scale - 21 items (DASS-21)
Time Frame: 4 weeks
A validated 21-item measure to assess the severity of depression, anxiety and stress components, with 7 items per component. Each item is scored from 0-3 where higher scores indicate higher levels of distress in anxiety (scores range from 0 to >20), depression (0 to >28) and/or stress (0 to >34).
4 weeks
Flinders Fatigue Scale (FFS)
Time Frame: 4 weeks
A self-report 7-item questionnaire to assess perception of frequency and severity of fatigue over the past 2 weeks. Global fatigue scores range from 0 to 31, where higher scores indicate greater fatigue.
4 weeks
Vivascentz(TM) Metric
Time Frame: 4 weeks
An in-house Givaudan wellbeing metric, and patent approved (WO2020165463). This 18-item scale measures transient feelings in the present moment assessing 9 positive and 9 negative attributes (reverse scored) to contribute to overall wellbeing scores. Scores range from 0 to 180, where higher scores indicate higher wellbeing.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Naturex

Investigators

  • Principal Investigator: Claire M Williams, Professor, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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