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

NCT05422599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-10-13

No results posted yet for this study

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.

Conditions

  • Sleep Disturbance
  • Mood Disturbance

Interventions

DIETARY_SUPPLEMENT

Lemon balm

300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L.

DIETARY_SUPPLEMENT

Placebo

300mg Maltodextrin capsules

Sponsors & Collaborators

  • Naturex

    collaborator OTHER

  • University of Reading

    lead OTHER

Principal Investigators

  • Claire M Williams, Professor · University of Reading

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2023-05-23
Completion
2023-05-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05422599 on ClinicalTrials.gov