Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000864224
Ethics application status
Approved
Date submitted
28/09/2009
Date registered
6/10/2009
Date last updated
6/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing anti-stress effects of lemon balm-containing foods
Scientific title
Assessing the anti-stress effects of lemon balm-containing foods in healthy participants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Function 243887 0
Stress 243888 0
Condition category
Condition code
Alternative and Complementary Medicine 252062 252062 0 0
Other alternative and complementary medicine
Mental Health 252063 252063 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study 1: Beverages
Study 1 will compare the effects of 480ml drinks containing
-1.8 g Lemon balm + Natural sweetener
-1 g Lemon balm + Natural sweetener
-1.8 g Lemon balm + artificial sweetener
-a placebo that containing artificial sweetener

Study 2. Dairy products
Study 2 will compare the effects of 250g dairy products (yoghurt drink) containing
- 1.8 g Lemon balm + Natural sweetener
- 1 g Lemon balm + Natural sweetener
- 1.8 g Lemon balm + artificial sweetener
- a placebo containing an artificial sweetener

Study 3. Bars
Study 3 will compare the effects of 35g fruit bars containing
- 1.8 g Lemon balm + Natural sweetener
- 1.8g Lemon balm + artificial sweetener
- Natural sweetener
- Artificial sweetener

For each study, participants consumed each treatment once only. There was a minimum 7 day washout period between each treatment within each study.

Participants were recruited for 1 study at a time. Therefore, it is possible that the same participants may respond to the advertisement of more than 1 study.
Intervention code [1] 241318 0
Behaviour
Comparator / control treatment
Placebo containing natural or artificial sweetener, identical to the active treatments
Control group
Placebo

Outcomes
Primary outcome [1] 252992 0
Stress reactivity measured using Mood questionnaires and cortisol measurements before and after a computerised stressor
Timepoint [1] 252992 0
1 hour and 3 hours post dose
Secondary outcome [1] 257759 0
Cognitive performance measured using the Purple Research Multitasking Framework
Timepoint [1] 257759 0
1 hour and 3 hours post dose

Eligibility
Key inclusion criteria
- non smoker
- aged between 18 and 40 years
- no history of anxiety, depression or psychiatric disorders
- not taking any medication, herbal extracts, vitamin supplements or illicit drugs
- no health conditions that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, celiac disease, peptic ulcers)
- not pregnant or breast feeding.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- smoker
- history of anxiety, depression or psychiatric disorders
- taking any medication, herbal extracts, vitamin supplements or illicit drugs
- health conditions that would effect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, peptic ulcers)
- pregnant or breast feeding.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants responded to advertisements in local papers and community bulletin boards. After successfully completing a telephone screen, they completed a practice session where they were introduced to the computerised test, passed a brief medical test and informed consent was obtained. They were then given a numerical identification number and was randomly allocated to a treatment series. Participants then returned for 4 testing sessions, receiving a different treatment each visit. The person who determined if a participant was eligible for inclusion in the trial was unaware, when this decision was made, to which group the participant would be allocated. Allocation was concealed by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party performed the randomisation sequence using a Latin Square to ensure a counter-balanced design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
randomised, double-blind, placebo-controlled methodology
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243806 0
Commercial sector/Industry
Name [1] 243806 0
Cognis
Country [1] 243806 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Cognis
Address
Rheinpromenade 1
D. 40789 Monheim
Country
Germany
Secondary sponsor category [1] 237158 0
None
Name [1] 237158 0
Address [1] 237158 0
Country [1] 237158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243937 0
Swinburne Univeristy Human Research Ethics Committee
Ethics committee address [1] 243937 0
PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 243937 0
Australia
Date submitted for ethics approval [1] 243937 0
Approval date [1] 243937 0
Ethics approval number [1] 243937 0
SUHREC 0708/105

Summary
Brief summary
The objectives of the current study is to conduct three studies to assess the effects of single doses of Melissa officinalis (Lemon balm), delivered in different food and drink products, on cognitive function, mood and cortisol. The products will vary across the three studies and will include Beverages (Study 1), Dairy products (Study 2), and food Bars (Study 3). This will be a randomised, double-blind, placebo-controlled, crossover study design involving a cohort of 20 healthy young adult volunteers in each study.
On each study day participants will undergo a baseline (pre-treatment) assessment of cognitive performance, mood and cortisol reactivity. They will undergo similar assessment 1 hour and 3 hours after treatment administration. The procedure will be repeated at weekly intervals until all doses are complete.

Each study will allow comprehensive conclusions regarding dose-dependent effects of Lemon balm (delivered in different foods) on:
- Mood including: Alertness, Calmness, Contentment
- Cognitive function including: Attention, Working memory, Secondary memory, and Executive function.
- Physiological index of stress: Salivary cortisol
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30311 0
Address 30311 0
Country 30311 0
Phone 30311 0
Fax 30311 0
Email 30311 0
Contact person for public queries
Name 13558 0
Prof Andrew Scholey
Address 13558 0
400 Burwood Rd
Hawthorn VIC 3122
Country 13558 0
Australia
Phone 13558 0
613 9214 8932
Fax 13558 0
Email 13558 0
[email protected]
Contact person for scientific queries
Name 4486 0
Prof Andrew Scholey
Address 4486 0
400 Burwood Rd
Hawthorn VIC 3122
Country 4486 0
Australia
Phone 4486 0
613 9214 8932
Fax 4486 0
Email 4486 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.