StressLemCogNCT06183372
Enhancement of Calmness and Mood Following Acute Lemon Balm Supplementation During Cognitive Demand in Adults
A study testing Lemon balm in people with Stress and Mood Disturbance, run by University of Reading at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Mood Disturbance
- What is being tested?
- Lemon balm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Dec 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-blind Placebo-controlled Acute Trial of Encapsulated Lemon Balm Efficacy and Tolerance on Calmness and Mood During Periods of Cognitive Demand
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).
Read the detailed description
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
- Stress, Mood Disturbance
- Being tested
- Lemon balm, Placebo
- Keywords
- Calmness, Subject Satisfaction, Mood enhancement, Relaxation, Lemon Balm, Melissa Officinalis, Herbal Psychotropic, Cognitive demand, Memory, Attention, Executive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemon balmDietary supplement
300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L.
PlaceboDietary supplement
300mg Maltodextrin capsules
| Study group | Role | What they receive |
|---|---|---|
| Lemon balm | Experimental | 300mg Lemon balm and Maltoxdextrin capsules Receives: Dietary Supplement: Lemon balm |
| Placebo | Placebo comparator | 300mg Maltodextrin capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: 5 hours following intervention
Secondary outcomes (49)
Fatigue 9-point Likert Scale
A validated 9-point Likert scale with Fatigue Anchor points (FAP) ranging from 1, "Not at all mentally fatigued" and 9, "Extremely mentally fatigued"
Measured: Baseline
Fatigue 9-point Likert Scale
A validated 9-point Likert scale with Fatigue Anchor points (FAP) ranging from 1, "Not at all mentally fatigued" and 9, "Extremely mentally fatigued"
Measured: 5 hours following intervention
Subject Satisfaction 4-point Category Scale
A two-part questionnaire based on a previously published 4-category rating questionnaire. The first part asks about current levels of tiredness and mental overload, using a 4-point Likert anchored from "not at all" (score 1) to "extremely" (score 4). The second part asks how satisfied a person is with their levels of tiredness and mental overload following supplementation, and asks them to rate their overall satisfaction with the supplement, using scales "not at all satisfied" (score 1) to "entirely satisfied" (score 4).
Measured: 1 hour following intervention
Subject Satisfaction 4-point Category Scale
A two-part questionnaire based on a previously published 4-category rating questionnaire. The first part asks about current levels of tiredness and mental overload, using a 4-point Likert anchored from "not at all" (score 1) to "extremely" (score 4). The second part asks how satisfied a person is with their levels of tiredness and mental overload following supplementation, and asks them to rate their overall satisfaction with the supplement, using scales "not at all satisfied" (score 1) to "entirely satisfied" (score 4).
Measured: 3 hours following intervention
Subject Satisfaction 4-point Category Scale
A two-part questionnaire based on a previously published 4-category rating questionnaire. The first part asks about current levels of tiredness and mental overload, using a 4-point Likert anchored from "not at all" (score 1) to "extremely" (score 4). The second part asks how satisfied a person is with their levels of tiredness and mental overload following supplementation, and asks them to rate their overall satisfaction with the supplement, using scales "not at all satisfied" (score 1) to "entirely satisfied" (score 4).
Measured: 5 hours following intervention
Visual Analogue Stress Scale
Ratings of stress are captured using 100mm Visual Analogue Scales anchored at each end by words descriptive of the minimal and maximal extremes of one statement (unipolar). On this linear scale, the person indicates how he or she is feeling at the moment by placing a mark between 2 statements concerning a specific condition of the dimension being measured. This brief instrument assesses levels of stress, anxiety, calmness and relaxation. Individual scores are combined to form 'stress/anxiety' and 'calm/relaxed' scores, where a higher score (average % along the line) represents more of the respective descriptor.
Measured: Baseline
Visual Analogue Stress Scale
Ratings of stress are captured using 100mm Visual Analogue Scales anchored at each end by words descriptive of the minimal and maximal extremes of one statement (unipolar). On this linear scale, the person indicates how he or she is feeling at the moment by placing a mark between 2 statements concerning a specific condition of the dimension being measured. This brief instrument assesses levels of stress, anxiety, calmness and relaxation. Individual scores are combined to form 'stress/anxiety' and 'calm/relaxed' scores, where a higher score (average % along the line) represents more of the respective descriptor.
Measured: 1 hour following intervention
Visual Analogue Stress Scale
Ratings of stress are captured using 100mm Visual Analogue Scales anchored at each end by words descriptive of the minimal and maximal extremes of one statement (unipolar). On this linear scale, the person indicates how he or she is feeling at the moment by placing a mark between 2 statements concerning a specific condition of the dimension being measured. This brief instrument assesses levels of stress, anxiety, calmness and relaxation. Individual scores are combined to form 'stress/anxiety' and 'calm/relaxed' scores, where a higher score (average % along the line) represents more of the respective descriptor.
Measured: 3 hours following intervention
Visual Analogue Stress Scale
Ratings of stress are captured using 100mm Visual Analogue Scales anchored at each end by words descriptive of the minimal and maximal extremes of one statement (unipolar). On this linear scale, the person indicates how he or she is feeling at the moment by placing a mark between 2 statements concerning a specific condition of the dimension being measured. This brief instrument assesses levels of stress, anxiety, calmness and relaxation. Individual scores are combined to form 'stress/anxiety' and 'calm/relaxed' scores, where a higher score (average % along the line) represents more of the respective descriptor.
Measured: 5 hours following intervention
Bond-Lader 16-item Visual Analogue Stress Scale
A widely used 16-item tool for measuring transient mood where 100mm scales anchored by various antonyms (e.g. Alert-Drowsy, Lethargic-Energetic) and are then clustered into respective mood factors alertness, calmness and contentedness
Measured: Baseline
Bond-Lader 16-item Visual Analogue Stress Scale
A widely used 16-item tool for measuring transient mood where 100mm scales anchored by various antonyms (e.g. Alert-Drowsy, Lethargic-Energetic) and are then clustered into respective mood factors alertness, calmness and contentedness
Measured: 1 hour following intervention
Bond-Lader 16-item Visual Analogue Stress Scale
A widely used 16-item tool for measuring transient mood where 100mm scales anchored by various antonyms (e.g. Alert-Drowsy, Lethargic-Energetic) and are then clustered into respective mood factors alertness, calmness and contentedness
Measured: 3 hours following intervention
Bond-Lader 16-item Visual Analogue Stress Scale
A widely used 16-item tool for measuring transient mood where 100mm scales anchored by various antonyms (e.g. Alert-Drowsy, Lethargic-Energetic) and are then clustered into respective mood factors alertness, calmness and contentedness
Measured: 5 hours following intervention
Immediate Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to episodic memory. In this task participants are visually presented with a sequential list of fifteen words where they are then given 1 minute to type as many words as they can remember. At each sitting of the task, a different word list will be presented which will be matched for linguistic familiarity, concreteness and frequency. The dependent variable is the number of words correctly recalled.
Measured: Baseline
Immediate Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to episodic memory. In this task participants are visually presented with a sequential list of fifteen words where they are then given 1 minute to type as many words as they can remember. At each sitting of the task, a different word list will be presented which will be matched for linguistic familiarity, concreteness and frequency. The dependent variable is the number of words correctly recalled.
Measured: 1 hour following intervention
Immediate Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to episodic memory. In this task participants are visually presented with a sequential list of fifteen words where they are then given 1 minute to type as many words as they can remember. At each sitting of the task, a different word list will be presented which will be matched for linguistic familiarity, concreteness and frequency. The dependent variable is the number of words correctly recalled.
Measured: 3 hours following intervention
Immediate Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to episodic memory. In this task participants are visually presented with a sequential list of fifteen words where they are then given 1 minute to type as many words as they can remember. At each sitting of the task, a different word list will be presented which will be matched for linguistic familiarity, concreteness and frequency. The dependent variable is the number of words correctly recalled.
Measured: 5 hours following intervention
Delayed Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to assess the level of delayed episodic memory. Participants will be required to type as many words as they can remember from the immediate word recall presentation after a delay of approximately 30 minutes following the initial presentation. The dependent variable is the number of words correctly recalled.
Measured: Baseline
Delayed Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to assess the level of delayed episodic memory. Participants will be required to type as many words as they can remember from the immediate word recall presentation after a delay of approximately 30 minutes following the initial presentation. The dependent variable is the number of words correctly recalled.
Measured: 1 hour following intervention
Delayed Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to assess the level of delayed episodic memory. Participants will be required to type as many words as they can remember from the immediate word recall presentation after a delay of approximately 30 minutes following the initial presentation. The dependent variable is the number of words correctly recalled.
Measured: 3 hours following intervention
Delayed Word Recall (Rey Auditory Verbal Learning Task)
A standardised cognitive measure to assess the level of delayed episodic memory. Participants will be required to type as many words as they can remember from the immediate word recall presentation after a delay of approximately 30 minutes following the initial presentation. The dependent variable is the number of words correctly recalled.
Measured: 5 hours following intervention
Modified Attention Network Task (with two blocks of Serial 3's)
A standardised measure to assess executive function and attention. In this task participants respond to the direction of a centrally presented arrow by pressing the corresponding left and right arrow keys. Across multiple trials, the target stimuli are either flanked by arrows pointing in the same direction (congruent) or opposite (incongruent). The number of flanking arrows also varies between trials (load). Two blocks are presented. In the second block, participants will be distracted by noise through headphones. In addition, during further subsections of the ANT an oral serial 3 (S3) subtractions task will also be performed to further assess attention and working memory function. In this S3 task participants subtract backwards starting with the number 50 until they can go no further. The S3 performance will be in place to add additional cognitive load and the dependent variable will be ANT performance (accuracy and reaction time) under varying conditions of congruency and load.
Measured: Baseline
Modified Attention Network Task (with two blocks of Serial 3's)
A standardised measure to assess executive function and attention. In this task participants respond to the direction of a centrally presented arrow by pressing the corresponding left and right arrow keys. Across multiple trials, the target stimuli are either flanked by arrows pointing in the same direction (congruent) or opposite (incongruent). The number of flanking arrows also varies between trials (load). Two blocks are presented. In the second block, participants will be distracted by noise through headphones. In addition, during further subsections of the ANT an oral serial 3 (S3) subtractions task will also be performed to further assess attention and working memory function. In this S3 task participants subtract backwards starting with the number 50 until they can go no further. The S3 performance will be in place to add additional cognitive load and the dependent variable will be ANT performance (accuracy and reaction time) under varying conditions of congruency and load.
Measured: 1 hour following intervention
Modified Attention Network Task (with two blocks of Serial 3's)
A standardised measure to assess executive function and attention. In this task participants respond to the direction of a centrally presented arrow by pressing the corresponding left and right arrow keys. Across multiple trials, the target stimuli are either flanked by arrows pointing in the same direction (congruent) or opposite (incongruent). The number of flanking arrows also varies between trials (load). Two blocks are presented. In the second block, participants will be distracted by noise through headphones. In addition, during further subsections of the ANT an oral serial 3 (S3) subtractions task will also be performed to further assess attention and working memory function. In this S3 task participants subtract backwards starting with the number 50 until they can go no further. The S3 performance will be in place to add additional cognitive load and the dependent variable will be ANT performance (accuracy and reaction time) under varying conditions of congruency and load.
Measured: 3 hours following intervention
Modified Attention Network Task (with two blocks of Serial 3's)
A standardised measure to assess executive function and attention. In this task participants respond to the direction of a centrally presented arrow by pressing the corresponding left and right arrow keys. Across multiple trials, the target stimuli are either flanked by arrows pointing in the same direction (congruent) or opposite (incongruent). The number of flanking arrows also varies between trials (load). Two blocks are presented. In the second block, participants will be distracted by noise through headphones. In addition, during further subsections of the ANT an oral serial 3 (S3) subtractions task will also be performed to further assess attention and working memory function. In this S3 task participants subtract backwards starting with the number 50 until they can go no further. The S3 performance will be in place to add additional cognitive load and the dependent variable will be ANT performance (accuracy and reaction time) under varying conditions of congruency and load.
Measured: 5 hours following intervention
Task Switching Test
A standardised cognitive task to assess executive function. In this task participants are presented with a computerised visual circle with 8 equally spaced radii that form 8 segments, 4 above and 4 below a bold line. A stimulus digit appears sequentially in each segment in a clockwise direction. If the digit was located above the bold line, participants then indicate whether the digit was odd or even using labelled arrow keys (left for odd, right for even). When the digit is below the bold line, participants again use the arrow keys to indicate whether the digit is higher or lower than 5 (left for higher, right for lower). The dependent variable will be TST performance (accuracy and reaction time) across all trials, and comparing switch trials (where the rule changes from the previous trial) and non-switch trials (where the rule stays the same as the previous trial).
Measured: Baseline
Task Switching Test
A standardised cognitive task to assess executive function. In this task participants are presented with a computerised visual circle with 8 equally spaced radii that form 8 segments, 4 above and 4 below a bold line. A stimulus digit appears sequentially in each segment in a clockwise direction. If the digit was located above the bold line, participants then indicate whether the digit was odd or even using labelled arrow keys (left for odd, right for even). When the digit is below the bold line, participants again use the arrow keys to indicate whether the digit is higher or lower than 5 (left for higher, right for lower). The dependent variable will be TST performance (accuracy and reaction time) across all trials, and comparing switch trials (where the rule changes from the previous trial) and non-switch trials (where the rule stays the same as the previous trial).
Measured: 1 hours following intervention
Task Switching Test
A standardised cognitive task to assess executive function. In this task participants are presented with a computerised visual circle with 8 equally spaced radii that form 8 segments, 4 above and 4 below a bold line. A stimulus digit appears sequentially in each segment in a clockwise direction. If the digit was located above the bold line, participants then indicate whether the digit was odd or even using labelled arrow keys (left for odd, right for even). When the digit is below the bold line, participants again use the arrow keys to indicate whether the digit is higher or lower than 5 (left for higher, right for lower).The dependent variable will be TST performance (accuracy and reaction time) across all trials, and comparing switch trials (where the rule changes from the previous trial) and non-switch trials (where the rule stays the same as the previous trial).
Measured: 3 hours following intervention
Task Switching Test
A standardised cognitive task to assess executive function. In this task participants are presented with a computerised visual circle with 8 equally spaced radii that form 8 segments, 4 above and 4 below a bold line. A stimulus digit appears sequentially in each segment in a clockwise direction. If the digit was located above the bold line, participants then indicate whether the digit was odd or even using labelled arrow keys (left for odd, right for even). When the digit is below the bold line, participants again use the arrow keys to indicate whether the digit is higher or lower than 5 (left for higher, right for lower).The dependent variable will be TST performance (accuracy and reaction time) across all trials, and comparing switch trials (where the rule changes from the previous trial) and non-switch trials (where the rule stays the same as the previous trial).
Measured: 5 hours following intervention
Rapid Visual Information Processing Task
A standardised cognitive task which involves presenting a series of digits on screen in quick succession. The participant will then be required to monitor the digits for sequences of three consecutive even or three consecutive odd digits. To indicate the end of a target sequence, participants will press the space bar as quickly as possible. The dependent variable is task performance (accuracy and reaction time).
Measured: Baseline
Rapid Visual Information Processing Task
A standardised cognitive task which involves presenting a series of digits on screen in quick succession. The participant will then be required to monitor the digits for sequences of three consecutive even or three consecutive odd digits. To indicate the end of a target sequence, participants will press the space bar as quickly as possible. The dependent variable is task performance (accuracy and reaction time).
Measured: 1 hour following intervention
Rapid Visual Information Processing Task
A standardised cognitive task which involves presenting a series of digits on a screen in quick succession. The participant will then be required to monitor the digits for sequences of three consecutive even or three consecutive odd digits. To indicate the end of a target sequence, participants will press the space bar as quickly as possible. The dependent variable is task performance (accuracy and reaction time).
Measured: 3 hours following intervention
Rapid Visual Information Processing Task
A standardised cognitive task which involves presenting a series of digits on a screen in quick succession. The participant will then be required to monitor the digits for sequences of three consecutive even or three consecutive odd digits. To indicate the end of a target sequence, participants will press the space bar as quickly as possible. The dependent variable is task performance (accuracy and reaction time).
Measured: 5 hours following intervention
Paced Auditory Serial Addition Task
A standardised cognitive task to assess attention and memory. The participant is presented with a string of auditory single digits and required to add each new digit to the one immediately prior to it out loud so that responses can be recorded. The dependent variable is therefore accuracy of calculation. The task comprises of 4, 2 minute blocks, where interstimulus time progressively decreases from 2.8 seconds to 1.6 seconds and cognitive demand therefore progressively increases.
Measured: Baseline
Paced Auditory Serial Addition Task
A standardised cognitive task to assess attention and memory. The participant is presented with a string of auditory single digits and required to add each new digit to the one immediately prior to it out loud so that responses can be recorded. The dependent variable is therefore accuracy of calculation. The task comprises of 4, 2 minute blocks, where interstimulus time progressively decreases from 2.8 seconds to 1.6 seconds and cognitive demand therefore progressively increases.
Measured: 1 hour following intervention
Paced Auditory Serial Addition Task
A standardised cognitive task to assess attention and memory. The participant is presented with a string of auditory single digits and required to add each new digit to the one immediately prior to it out loud so that responses can be recorded. The dependent variable is therefore accuracy of calculation. The task comprises of 4, 2 minute blocks, where interstimulus time progressively decreases from 2.8 seconds to 1.6 seconds and cognitive demand therefore progressively increases.
Measured: 3 hours following intervention
Paced Auditory Serial Addition Task
A standardised cognitive task to assess attention and memory. The participant is presented with a string of auditory single digits and required to add each new digit to the one immediately prior to it out loud so that responses can be recorded. The dependent variable is therefore accuracy of calculation. The task comprises of 4, 2 minute blocks, where interstimulus time progressively decreases from 2.8 seconds to 1.6 seconds and cognitive demand therefore progressively increases.
Measured: 5 hours following intervention
Systolic Blood Pressure
Average (triplicate) resting brachial left arm cuffed systolic blood pressure mmHg
Measured: Baseline
Systolic Blood Pressure
Average (triplicate) resting brachial left arm cuffed systolic blood pressure mmHg
Measured: 1 hour following intervention
Systolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed systolic blood pressure mmHg
Measured: 3 hour following intervention
Systolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed systolic blood pressure mmHg
Measured: 5 hour following intervention
Diastolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed diastolic blood pressure mmHg
Measured: Baseline
Diastolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed diastolic blood pressure mmHg
Measured: 1 hour following intervention
Diastolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed diastolic blood pressure mmHg
Measured: 3 hours following intervention
Diastolic Blood Pressure
Average (triplicate) resting brachial (left arm) cuffed diastolic blood pressure mmHg
Measured: 5 hours following intervention
Heart Rate
Average (triplicate) resting brachial (left arm) cuffed heart rate bpm
Measured: Baseline
Heart Rate
Average (triplicate) resting brachial (left arm) cuffed heart rate bpm
Measured: 1 hour following intervention
Heart Rate
Average (triplicate) resting brachial (left arm) cuffed heart rate bpm
Measured: 3 hours following intervention
Heart Rate
Average (triplicate) resting brachial (left arm) cuffed heart rate bpm
Measured: 5 hours following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start2 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between- and within-groups (mixed) model
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
- Investigators
- Claire M Williams, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183372
- Sponsor's protocol ID
- 23/25
- Acronym
- LemCog
- Status last verified
- Aug 2024
- First submitted
- 13 Dec 2023
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.
Publications
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.
PubMed 34788575Ghazizadeh 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.
PubMed 34449930Mathews I, Eastwood J, Bell L, Lamport D, Le Cozannet R, Fanca-Berthon P, Williams C. The acute effects of Zensera (Melissa officinalis L.) extract on mood and cognitive performance during cognitive overload: a randomised placebo-controlled, double-blind study in healthy young adults with moderate subjective stress. Ther Adv Psychopharmacol. 2026 Feb 28;16:20451253261415706. doi: 10.1177/20451253261415706. eCollection 2026.
PubMed 41782777
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Placebo-controlled Acute Trial of Encapsulated Lemon Balm Efficacy and Tolerance on Calmness and Mood During Periods of Cognitive Demand
- ClinicalTrials.gov ID
- NCT06183372
- Acronym / sponsor ID
- LemCog / 23/25
- Conditions
- Stress, Mood Disturbance
- Keywords
- Calmness, Subject Satisfaction, Mood enhancement, Relaxation, Lemon Balm, Melissa Officinalis, Herbal Psychotropic, Cognitive demand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Naturex
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between- and within-groups (mixed) model
| Arm | Type | Receives |
|---|---|---|
| Lemon balm | Experimental | Dietary Supplement: Lemon balm300mg Lemon balm and Maltoxdextrin capsules |
| Placebo | Placebo comparator | Dietary Supplement: Placebo300mg Maltodextrin capsules |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemon balm300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L. | Dietary supplement | Lemon balm |
| Placebo300mg Maltodextrin capsules | Dietary supplement | Placebo |
Primary outcome
Calmness 9-point Likert Scale
Time frame: Baseline
A validated 9-point Likert scale with Calmness Anchor points (CAP) ranging from 1, "Not at all Calm" to 9, "Extremely Calm"
Calmness 9-point Likert Scale
Time frame: 5 hours following intervention
A validated 9-point Likert scale with Calmness Anchor points (CAP) ranging from 1, "Not at all Calm" to 9, "Extremely Calm"
49 secondary outcomes
Fatigue 9-point Likert Scale
Time frame: Baseline
Fatigue 9-point Likert Scale
Time frame: 5 hours following intervention
Subject Satisfaction 4-point Category Scale
Time frame: 1 hour following intervention
Subject Satisfaction 4-point Category Scale
Time frame: 3 hours following intervention
Subject Satisfaction 4-point Category Scale
Time frame: 5 hours following intervention
Visual Analogue Stress Scale
Time frame: Baseline
Visual Analogue Stress Scale
Time frame: 1 hour following intervention
Visual Analogue Stress Scale
Time frame: 3 hours following intervention
Visual Analogue Stress Scale
Time frame: 5 hours following intervention
Bond-Lader 16-item Visual Analogue Stress Scale
Time frame: Baseline
Bond-Lader 16-item Visual Analogue Stress Scale
Time frame: 1 hour following intervention
Bond-Lader 16-item Visual Analogue Stress Scale
Time frame: 3 hours following intervention
Bond-Lader 16-item Visual Analogue Stress Scale
Time frame: 5 hours following intervention
Immediate Word Recall (Rey Auditory Verbal Learning Task)
Time frame: Baseline
Immediate Word Recall (Rey Auditory Verbal Learning Task)
Time frame: 1 hour following intervention
Immediate Word Recall (Rey Auditory Verbal Learning Task)
Time frame: 3 hours following intervention
Immediate Word Recall (Rey Auditory Verbal Learning Task)
Time frame: 5 hours following intervention
Delayed Word Recall (Rey Auditory Verbal Learning Task)
Time frame: Baseline
Delayed Word Recall (Rey Auditory Verbal Learning Task)
Time frame: 1 hour following intervention
Delayed Word Recall (Rey Auditory Verbal Learning Task)
Time frame: 3 hours following intervention
Delayed Word Recall (Rey Auditory Verbal Learning Task)
Time frame: 5 hours following intervention
Modified Attention Network Task (with two blocks of Serial 3's)
Time frame: Baseline
Modified Attention Network Task (with two blocks of Serial 3's)
Time frame: 1 hour following intervention
Modified Attention Network Task (with two blocks of Serial 3's)
Time frame: 3 hours following intervention
Modified Attention Network Task (with two blocks of Serial 3's)
Time frame: 5 hours following intervention
Task Switching Test
Time frame: Baseline
Task Switching Test
Time frame: 1 hours following intervention
Task Switching Test
Time frame: 3 hours following intervention
Task Switching Test
Time frame: 5 hours following intervention
Rapid Visual Information Processing Task
Time frame: Baseline
Rapid Visual Information Processing Task
Time frame: 1 hour following intervention
Rapid Visual Information Processing Task
Time frame: 3 hours following intervention
Rapid Visual Information Processing Task
Time frame: 5 hours following intervention
Paced Auditory Serial Addition Task
Time frame: Baseline
Paced Auditory Serial Addition Task
Time frame: 1 hour following intervention
Paced Auditory Serial Addition Task
Time frame: 3 hours following intervention
Paced Auditory Serial Addition Task
Time frame: 5 hours following intervention
Systolic Blood Pressure
Time frame: Baseline
Systolic Blood Pressure
Time frame: 1 hour following intervention
Systolic Blood Pressure
Time frame: 3 hour following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 34788575Bertuccioli 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.
- Background: PubMed 34449930Ghazizadeh 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.
- Derived from this study: PubMed 41782777Mathews I, Eastwood J, Bell L, Lamport D, Le Cozannet R, Fanca-Berthon P, Williams C. The acute effects of Zensera (Melissa officinalis L.) extract on mood and cognitive performance during cognitive overload: a randomised placebo-controlled, double-blind study in healthy young adults with moderate subjective stress. Ther Adv Psychopharmacol. 2026 Feb 28;16:20451253261415706. doi: 10.1177/20451253261415706. eCollection 2026.
- 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. GabLink provided by the sponsor.
- Pass, F., Renkl, A., \& Sweller, J. (2004). Cognitive Load Theory: Instructional Implications of the Interaction between Information Structures and Cognitive Architecture. Instructional Science, 32(1-2), 1-8.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data may be made available on a platform such as Open Science Framework (www.osf.io) or a data repository linked to academic journals, in accordance with Open Science principles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire M Williams principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lemon balm in people with Stress and Mood Disturbance, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calmness 9-point Likert Scale (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183372, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.