Enhancement of Sleep Quality and Mood Following Supplementation With Lemon Balm in an Adult Population (Lemslp)
Condition: Sleep Disturbance; Mood Disturbance
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

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).
    

Intervention name(s): Lemon balm; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L.; 300mg Maltodextrin capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between and within groups model
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
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