Enhancement of Calmness and Mood Following Acute Lemon Balm Supplementation During Cognitive Demand in Adults

NCT06183372 | Completed

• 1 other identifier: 23/25
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of a single dose (300mg) of encapsulated aqueous lemon balm extract on measures of calmness and mood during periods of cognitive demand over the course of the day in healthy adults aged 18-40 years with moderate stress (PSS entry between 14 to 26).

Conditions

Stress; Mood Disturbance

Keywords

Calmness; Subject Satisfaction; Mood enhancement; Relaxation; Lemon Balm; Melissa Officinalis; Herbal Psychotropic; Cognitive demand; Memory; Attention; Executive Function

Outcome Measures

Primary Outcomes (2)

• Calmness 9-point Likert Scale

  A validated 9-point Likert scale with Calmness Anchor points (CAP) ranging from 1, "Not at all Calm" to 9, "Extremely Calm"

  Baseline

• Calmness 9-point Likert Scale

  A validated 9-point Likert scale with Calmness Anchor points (CAP) ranging from 1, "Not at all Calm" to 9, "Extremely Calm"

  5 hours following intervention

Secondary Outcomes (49)

• Fatigue 9-point Likert Scale

  Baseline

• Fatigue 9-point Likert Scale

  5 hours following intervention

• Subject Satisfaction 4-point Category Scale

  1 hour following intervention

• Subject Satisfaction 4-point Category Scale

  3 hours following intervention

• Subject Satisfaction 4-point Category Scale

  5 hours following intervention

Study Arms (2)

Lemon balm

EXPERIMENTAL

300mg Lemon balm and Maltoxdextrin capsules

Dietary Supplement: Lemon balm

Placebo

PLACEBO COMPARATOR

300mg Maltodextrin capsules

Dietary Supplement: Placebo

Interventions

Lemon balm DIETARY_SUPPLEMENT

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

Lemon balm

Placebo DIETARY_SUPPLEMENT

300mg Maltodextrin capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, between 18-40 years old
• Moderate Stress problems (PSS between 14 to 26)
• No alcohol or vigorous activity 24h before the task
• No coffee/caffeine intake 12h before the visits
• Non-smokers or Must not smoke during 7 days prior to the trial: Includes smoking tobacco, vaping nicotine, using nicotine replacement products, or occasional social smoking.
• Willingness to wash out for food supplementation during 2 weeks before the experiment

You may not qualify if:

• 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
• Have any allergic reactions to ingredients in the capsules
• Consumed more than 400 mg of caffeine (\>5 expresso) per day in the past 2 weeks
• Have used any psychotropic medications, stimulants, cannabis, non-registered drug products, or illicit substances in the past 2 weeks, were at risk of drug or alcohol abuse
• Taking any dietary supplements which they are unwilling to stop for the duration of the study
• Have sleep disorders or are taking sleep aid medication
• Fail to demonstrate adequate minimal performance on lab, computer-based cognitive tasks
• Have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism, ADHD).

Sponsors & Collaborators

• University of Reading: lead
• Naturex: collaborator

Study Sites (1)

University of Reading

Reading, RG2 9AH, United Kingdom

Location

Related Publications (2)

• Bertuccioli A, Cardinali M, Di Pierro F, Magi S, Zonzini G. A Practical Perspective on the Use of Botanicals During the COVID-19 Pandemic: From Proven to Potential Interactions. J Med Food. 2022 Jan;25(1):1-11. doi: 10.1089/jmf.2021.0062. Epub 2021 Nov 17.

  PMID: 34788575 BACKGROUND

• Ghazizadeh J, Sadigh-Eteghad S, Marx W, Fakhari A, Hamedeyazdan S, Torbati M, Taheri-Tarighi S, Araj-Khodaei M, Mirghafourvand M. The effects of lemon balm (Melissa officinalis L.) on depression and anxiety in clinical trials: A systematic review and meta-analysis. Phytother Res. 2021 Dec;35(12):6690-6705. doi: 10.1002/ptr.7252. Epub 2021 Aug 27.

  PMID: 34449930 BACKGROUND

Related Links

• Eppler, M.J., Mengis, J. (2008). The Concept of Information Overload - A Review of Literature from Organization Science... (2004). In: Meckel, M., Schmid, B.F. (eds) Kommunikationsmanagement im Wandel. Gab

MeSH Terms

Interventions

lemon balm leaf extract

Study Officials

• Claire M Williams

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Neuroscience

Model Details: Between- and within-groups (mixed) model

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: December 2, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

GB (1)