Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183372
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2023-12-13
Brief Title:
Enhancement of Calmness and Mood Following Acute Lemon Balm Supplementation During Cognitive Demand in Adults
Sponsor:
University of Reading
Organization:
University of Reading
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LemCog
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None