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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2024-07-31

Brief Summary

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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).

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Detailed Description

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Cognitive overload can be a common occurrence in an information saturated world (Eppler et al., 2008; Graf et al., 2021; Pass et al., 2004), and chronic cognitive overload is considered an initiating step in the emergence of various physical and emotional health concerns, likely due to high processing demands on the working memory neural system (Graf et al., 2021). Over time, psychological and physiological stress may arise, however current chemical interventions may be unsuitable for those experiencing mild-to-moderate levels of stress (Ghazizadeh et al., 2021). Indeed, long-term use of psychotropic medicines have previously been associated with a worsening of psychological symptoms (Bertuccioli et al., 2022). Therefore, identifying interventions for those experiencing mild-to-moderate stress will have strong public health implications for the prevention or reduction of symptoms. In addition, an opportunity for dietary supplementation as an over-the-counter option for those who do not wish to take chemical interventions is becoming a popular choice (Ghazizadeh et al., 2021; Bertuccioli et al. 2022).

The current study will employ a parallel, double-blind, randomised placebo-controlled trial, assessing the effect of a single dose intervention of lemon balm extract (or matched placebo) in young-to-middle-aged adults with moderate levels of perceived stress. Subjects will be pre-screened to determine eligibility using the perceived stress questionnaire, where scores between 14 to 26 are indicative of moderate stress, to provide a total of 130 participants. The study comprises a familiarisation visit followed by an acute test day at the Nutritional Psychology Unit based at the University of Reading. The familiarisation visit will allow participants to practice the cognitive battery, complete calmness and mood measures, and provide information on habitual diet (Epic-Norfolk FFQ) and general health and lifestyle patterns to confirm eligibility. On the acute test day, subjective calmness and mood ratings will be recorded at various timepoints throughout the day, beginning with an initial baseline measurement (0h), and then 1h, 3h and 5h after consuming an acute dose of lemon balm extract (300mg) or a matched placebo. At these same timepoints, a computer-based cognitive battery will be completed, consisting of several tasks assessing domains of executive function, attention and memory. On the acute test day participants will arrive fasted and will be provided with a standardised breakfast (two croissants and a glass of water) to be consumed prior to 0h baseline measures. A standardised lunch (cheese sandwich, packet of crisps, and water) will also be provided after the 3h timepoint.

Conditions

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Stress Mood Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between- and within-groups (mixed) model

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Double-blind

Study Groups

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Lemon balm

300mg Lemon balm and Maltoxdextrin capsules

Group Type EXPERIMENTAL

Lemon balm

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

300mg Maltodextrin capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

300mg Maltodextrin capsules

Interventions

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Lemon balm

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

300mg Maltodextrin capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

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
* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes