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
ACTRN12616000947404
Ethics application status
Approved
Date submitted
14/07/2016
Date registered
18/07/2016
Date last updated
20/08/2019
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-term effects of Tulsi herbal tea on mood, stress, cognition and cardiovascular function
Scientific title
Short-term effects of Tulsi on mood, stress, cognition and cardiovascular function
Secondary ID [1] 289679 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
TETRACE (Tulsi Effect on Thought Relaxation Awareness Cardiovascular & Emotion)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mood 299478 0
cognitive health 299479 0
cardiovascular function 299480 0
Stress 307398 0
Condition category
Condition code
Alternative and Complementary Medicine 299458 299458 0 0
Herbal remedies
Mental Health 299459 299459 0 0
Other mental health disorders
Mental Health 299460 299460 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 306505 306505 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a preliminary randomized placebo-controlled cross-over study comparing the time course of changes in mood,, stress, cognitive health and cardiovascular function after a single dose of 250ml tulsi tea (hot to warm) and 250ml filtered water (hot to warm).

The interventions will be either two tea bags of Tulsi herbal tea (1.8g each tea bag) standardized commercial grade tea bag steeped in 250ml filtered warm-hot water or Placebo decaff black tea 250ml.

Participants will receive the two interventions as a beverage on two separate occasions in a randomized crossover sequence with a minimum of 48 hours washout.
Doses will be administered by healthcare professionals at the study site.
Intervention code [1] 295302 0
Treatment: Other
Comparator / control treatment
control will be 250ml of decaf black tea in warm-hot filtered water to match the active intervention volume
Control group
Placebo

Outcomes
Primary outcome [1] 305509 0
Cognitive Function assessed using CogState computerized battery
Timepoint [1] 305509 0
at baseline and after 40 min, 120 min and 180 min post intervention
(120 and 180 min will be only tested in up to 10 participants)
Primary outcome [2] 308136 0
Measurement of the Mood states using the brief version of Profile of Mood States (POMS) questionnaire consisting of 37-adjectives that participants will rate the level (1-5 scale) at which they have been feeling before the drink, and 40 minutes after the consumption of the drink.
Timepoint [2] 308136 0
baseline and 40 minutes
Secondary outcome [1] 325715 0
Cardiovascular function assessment (pulse rate, brachial blood pressure, central blood pressure and arterial stiffness) will be performed using the SphygmoCor technology which is a validated measure of central aortic pressure pulse wave parameters. The blood pressure will be measured twice following 5 minutes seated rest using SphygmoCor (AtCor Medical, Sydney, Australia).
this is a composite outcome
Timepoint [1] 325715 0
at baseline and after 40 min, 120 min and 180 min post intervention
(120 and 180 min will be only tested in up to 10 participants)
Secondary outcome [2] 345525 0
stress, is assessed by salivary cortisol using ELISA assay
Timepoint [2] 345525 0
measured at baseline and after 40 minutes

Eligibility
Key inclusion criteria
-aged between 18 and 60 years, English speaking and able to give written informed consent
-non-smokers
- willing to avoid caffeine-containing drinks, alcohol and prescription medications for 24 hours prior to the testing sessions
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are designed to exclude confounding factors that may impact on cognitive, physiological or metabolic function. People with be excluded if they are:
- Smokers
- Have known allergies to basil or herbal tea
- Have diabetes or a severe chronic infection or illness that may impact on the outcome measures such as current or previous history of renal, cardiac, gastrointestinal, liver or psychiatric disorders or pulmonary (other than either asthma not requiring continuous medication or sleep apnoea-related disorders), or any other condition that in the opinion of the investigators would impede competence, compliance, or participation in the study.
-Taking blood thinner medication
-pregnant or expect to be pregnant
- Unable to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
no allocation concealment applies
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are allocated to either active intervention or placebo using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Statistical Package for the Social Sciences software (SPSS Inc., Armonk, New York, USA) will be used for data analysis. As this is an exploratory pilot study using pooled data, no inferential statistical tests are proposed (data analysis will mainly involve descriptive statistics) and therefore it is not deemed necessary to conduct a formal power analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2018
Actual
23/05/2018
Date of last participant enrolment
Anticipated
Actual
27/08/2018
Date of last data collection
Anticipated
27/07/2018
Actual
15/09/2018
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13603 0
3083 - Bundoora
Recruitment postcode(s) [2] 22624 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 294060 0
University
Name [1] 294060 0
RMIT
Country [1] 294060 0
Australia
Primary sponsor type
Individual
Name
Professor Marc Cohen
Address
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora, VICTORIA 3083
Country
Australia
Secondary sponsor category [1] 292889 0
None
Name [1] 292889 0
Address [1] 292889 0
Country [1] 292889 0
Other collaborator category [1] 280096 0
University
Name [1] 280096 0
Professor Jiming Ye
Address [1] 280096 0
Health and biomedical Sciences, RMIT Bundoora campus
Country [1] 280096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295475 0
Human research ethics committee (RMIT)
Ethics committee address [1] 295475 0
Plenty Road
Bundoora
VIC
3083
Ethics committee country [1] 295475 0
Australia
Date submitted for ethics approval [1] 295475 0
04/07/2016
Approval date [1] 295475 0
18/08/2016
Ethics approval number [1] 295475 0
20015

Summary
Brief summary
Tulsi or Holy Basil is an Indian herb used for centuries for coping with stress as well as for the treatment of Type 2 Diabetes (T2D) and other cardiometabolic disorders. Tulsi tea is widely available throughout the world as a caffeine free herbal tea with no reported side effects in literature associated with regular consumption of tulsi tea.
Considerable evidence in animal models shows that tulsi improves cognition, immunity, stress and cardiometabolic disorders. Also accumulating evidence from human trials indicate that long-term tulsi ingestion improves mood, cognition and cardiometabolic function. However, there are no published reports on short term effects of tulsi on these pathways in humans. In addition, only a few of the clinical trials have looked at the effect of tulsi consumption in healthy adults who are infact the majority of the tea drinker population.
Potential outcomes of this clinical trial are not only to support traditional effectiveness and safety of tulsi but also to stimulate further research into the numerous healing potentials of this Ayurvedic sacred herb.

This project aims to explore time course of mood, cognition and cardiovascular functional changes after the consumption of a single cup of tulsi tea in healthy people. In addition, since cortisol is a well-established biomarker of mental stress, known to control blood pressure (Kelly et al., 1998) and high cortisol levels found to be associated with reduced cognitive function such as memory (Shirbin et al., 2013), therefore acute change in cortisol activity was also assessed.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67390 0
Prof Marc Cohen
Address 67390 0
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country 67390 0
Australia
Phone 67390 0
+61 3 9925 7440
Fax 67390 0
Email 67390 0
[email protected]
Contact person for public queries
Name 67391 0
Prof Marc Cohen
Address 67391 0
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country 67391 0
Australia
Phone 67391 0
+61 3 9925 7440
Fax 67391 0
Email 67391 0
[email protected]
Contact person for scientific queries
Name 67392 0
Prof Marc Cohen
Address 67392 0
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country 67392 0
Australia
Phone 67392 0
+61 3 9925 7440
Fax 67392 0
Email 67392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data is confidential


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4164Ethical approval  [email protected]
4165Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The research question was whether a single cup of ... [More Details]

Documents added automatically
No additional documents have been identified.