Clinical trial NCT05422599: Enhancement of Sleep Quality and Mood Following Supplementation With Lemon Balm in an Adult Population (Lemslp)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Naturex
First posted: 2022-06-16
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between and within groups model
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Combined Sleep Diary and Research-Grade Actiwatch Sleep-Wake Patterns
timeFrame: Continuous over 4 weeks
measure: Diurnal Salivary Cortisol and Melatonin Patterns
timeFrame: 4 weeks
measure: Gut Microbiota Changes
timeFrame: 4 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 4 weeks
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: 4 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 4 weeks
measure: Positive affect as measured by PANAS-X
timeFrame: 4 weeks
measure: Positive affect as measured by PANAS-NOW
timeFrame: 4 weeks
measure: Negative affect as measured by PANAS-X
timeFrame: 4 weeks
measure: Negative affect as measured by PANAS-NOW
timeFrame: 4 weeks
measure: Depression, Anxiety and Stress Scale - 21 items (DASS-21)
timeFrame: 4 weeks
measure: Flinders Fatigue Scale (FFS)
timeFrame: 4 weeks
measure: Vivascentz(TM) Metric
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: School of Psychology and Clinical Languages, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Claire M Williams, Professor
role: PRINCIPAL_INVESTIGATOR
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