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

University of Reading

Status: Completed

Conditions: Sleep Disturbance; Mood Disturbance

Treatments: Dietary Supplement: Lemon balm; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05422599

22/01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 99 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 2 patient groups, including a placebo group

Lemon balm

Experimental group

Description:

300mg Lemon balm and Maltodextrin

Treatment:

Dietary Supplement: Lemon balm

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo