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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Pittsburgh Sleep Quality Index (PSQI)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Lemon balm
300mg Lemon balm and Maltodextrin
Intervention: Lemon balm (Dietary Supplement)
Placebo
Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Perceived Stress Scale (PSS)(4 weeks)
- Positive affect as measured by PANAS-X(4 weeks)
- Positive affect as measured by PANAS-NOW(4 weeks)
- Negative affect as measured by PANAS-X(4 weeks)
- Negative affect as measured by PANAS-NOW(4 weeks)
- Depression, Anxiety and Stress Scale - 21 items (DASS-21)(4 weeks)
- Flinders Fatigue Scale (FFS)(4 weeks)
- Vivascentz(TM) Metric(4 weeks)
Investigators
Prof Claire Williams
Chair of Neuroscience
University of Reading