Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000432415p
Ethics application status
Submitted, not yet approved
Date submitted
31/03/2016
Date registered
5/04/2016
Date last updated
27/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Short term effects of herbal tea on mood, cognition and metabolic performance
Scientific title
Short term effects of herbal tea on mood, cognition and metabolic performance in healthy volunteers, elite athletes and individuals with impaired glucose metabolism
Secondary ID [1] 288855 0
NIL
Universal Trial Number (UTN)
U1111-1181-3466
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognition 298150 0
metabolic syndrome 298242 0
mood 299200 0
Condition category
Condition code
Alternative and Complementary Medicine 298313 298313 0 0
Herbal remedies
Metabolic and Endocrine 298314 298314 0 0
Metabolic disorders
Mental Health 298316 298316 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-centre, double-blind, randomised, controlled, cross-over study comparing the effects of a single dose of tulsi tea and tulsi combined with other herbs such as turmeric to consumption of a sports drink or regular (decaffeinated) tea in healthy adults, elite athletes and people with impaired glucose control.
The interventions will be:
(1) Tulsi herbal tea 2g (standardized commercial grade Tulsi herbal blend 250ml) warm-hot
(2) Tulsi, turmeric herbal blend 250ml (containing 2g of ground turmeric, 2g Tulsi, 5 g of coconut oil and a blend of other spices) warm-hot
(3) Decaffeinated black tea 250ml warm-hot
(4) Sports beverage (Gatorade Zero sugar) 250ml (room temperature-cold drink)

Participants within each group will receive the four interventions as a beverage on four separate occasions in a double-blinded, crossover, randomised sequence with a wash out period of at least 24 hours. The athlete group will follow the same procedures as the other groups with and without inclusion of a post-intervention beep test. Each beverage consists of freely available food items and will only be given on a single occasion to each subject. As these drinks are not purported to be therapeutic goods and will not appear with any labels or claims, a Clinical Trials Notification is not required. There are no risks anticipated from participation in this study other the risks associated with giving a standard blood sample.
Intervention code [1] 294321 0
Treatment: Other
Comparator / control treatment
The comparator will be
- Decaffeinated black tea 250ml warm-hot
-Sports beverage (Gatorade Zero sugar) 250ml
Control group
Active

Outcomes
Primary outcome [1] 298688 0
Cognitive Function assessed using CogState computerized battery
Timepoint [1] 298688 0
at baseline, after 60minutes following treatment (T60)
Secondary outcome [1] 322454 0
blood pressure measured by an oscillometric device
Timepoint [1] 322454 0
baseline, at 1 hour (T1), 2 hours (T2) and 4 hours (T4)
Secondary outcome [2] 322456 0
Measurement of the Mood states using a Profile of Mood States (POMS) questionnaire consisting of 65-adjectives that participants will rate on a 5-point scale.

The 1-5 Likert scale (1 being “not at all” and 5 being “extremely) will be used for Participants to rate the level at which they have been feeling during the study.
Timepoint [2] 322456 0
test will be conducted at base line and at 1 hour post intervention
Secondary outcome [3] 324970 0
Aerobic Capacity testing (VO2). This outcome will be measured using beep test
Timepoint [3] 324970 0
measured only 30 minutes after intervention (T30)
Secondary outcome [4] 324971 0
fasting blood glucose levels
Timepoint [4] 324971 0
measured at baseline and after 60minutes post intervention
Secondary outcome [5] 324972 0
RNA transcriptome analysis of blood samples
Timepoint [5] 324972 0
at baseline and after 60minutes post intervention

Eligibility
Key inclusion criteria
Group 1-Healthy volunteers
-Non-smoker
-Age between 18 and 60 years
- English speaking
-Healthy (absence of all exclusion criteria) male and female adults
- Not taking any medication, herbal extracts, vitamin supplements or illicit drugs
- Participants must avoid caffeine-containing drinks and alcohol for 24 hours prior to the testing sessions
- Written informed consent

Group2- Elite Athletes
Non-smoker
- Elite athlete participating at competition level team sports
-Age between 18 and 60 years
- English speaking
-Healthy (absence of all exclusion criteria) male and female adults
- Not taking any medication, herbal extracts, vitamin supplements or illicit drugs
- Participants must avoid caffeine-containing drinks and alcohol for 24 hours prior to the testing sessions
- Written informed consent

Group 3-impaired glucose individuals
Non-smoker
-consist of people with impaired glucose control as defined by Fasting Blood Glucose between 5.5 - 6.9mmol/L or Random Blood Glucose between 5.5-11 mmol/L
-Age between 18 and 60 years
- English speaking
-Healthy (absence of all exclusion criteria) male and female adults
- Not taking any medication, herbal extracts, vitamin supplements or illicit drugs
- Participants must avoid caffeine-containing drinks and alcohol for 24 hours prior to the testing sessions
- Written informed consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Smokers
-Taking herbal extracts, vitamin supplements or illicit drugs
-diagnosed with diabetes
-chronic infection or illness
-Current or previous history of cardiac, gastrointestinal, liver or psychiatric disorders
- regular consumption of Tulsi tea
- Reported participation in another related trial within three months or during this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group 1- Healthy volunteers will be recruited using the researchers networks and via social media (Face book, Instagram and Twitter) along with flyers posted at various locations including on RMIT website.
Group 2- Elite athlete participants will be recruited through social media (Face book, Instagram and Twitter) along with flyers and posters posted on the Victorian Institute of Sports noticeboards.
Group 3- People with impaired glucose control will be recruited via social media and through posters and flyers placed in reception area of local clinics and in the GP rooms. Local GPs will be approached and invited to promote the study to their patients

Prior to entering the participants into the trial, written consent will be obtained from each subject. Information will be given in both oral and written form and participants will be given ample opportunity to inquire about details of the study. The participant will be given a copy of the signed consent form and the original will be maintained with the records of the participant.

The participant will be enrolled into this study after the informed consent process has been signed. The participant will receive a study enrolment number on the first day of study and this will be recorded on all study documents.
Study will be conducted at Bundoora and/or City Campus of RMIT University. The athlete testing may also take place at the Victorian Institute of Sport or an appropriate facility at RMIT University. The expected start will be as soon as Ethics approval has been confirmed and the study will end as soon as the last group of participants have completed the four arms of study. It is anticipated that this could take up to 18 months to complete.


All the study interventions will be provided in opaque capped cups or bottles that are coded for each participant based on predetermined code generated by a randomized computer number sequence generator so that participant receives each of the four interventions in a random order counterbalanced across the participants. The coding will use blocked randomisation with blocks of 4, to ensure that each block of 4 participants receive each of the four interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated using a computerized sequence generator by a disinterested third party.
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
Participants will be recruited through advertising using online platform. The volunteers will be randomly allocated to receive one of the three treatment arms on their first testing day.

All three treatments with treatment order counterbalanced across participants will be completed by end of the study with a week washout period between each treatment arm.
A disinterested third party will be responsible for the blinding procedure.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2017
Actual
Date of last participant enrolment
Anticipated
28/02/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12996 0
3000 - Melbourne
Recruitment postcode(s) [2] 12997 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 294069 0
University
Name [1] 294069 0
RMIT
Country [1] 294069 0
Australia
Primary sponsor type
Individual
Name
Professor Marc Cohen
Address
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country
Australia
Secondary sponsor category [1] 292046 0
None
Name [1] 292046 0
Address [1] 292046 0
Country [1] 292046 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294722 0
RMIT UNIVERSITY HUMAN RESEARCH ETHICS COMMITEE
Ethics committee address [1] 294722 0
Plenty Road
Bundoora
VIC
3083
Ethics committee country [1] 294722 0
Australia
Date submitted for ethics approval [1] 294722 0
04/04/2016
Approval date [1] 294722 0
Ethics approval number [1] 294722 0

Summary
Brief summary
Tulsi (Holy basil) is a sacred Indian herb with a remarkable therapeutic range in the treatment of common conditions including metabolic disorders. Considerable evidence in preclinical models indicates a role for Tulsi in improving metabolic disorders, mood as well as cognitive related diseases. There is emerging evidence from few randomized clinical trials demonstrating the efficacy of Tulsi in metabolic disorders and improvement of mood and cognition state in healthy individuals. Similarly, turmeric administration (another Indian culinary herb) has been found to improve cognitive function and mood in healthy and pre-diabetic adults.
There have been considerable efforts to characterize transcriptomes and identify biomarkers specific for metabolic pathways. Recent studies using whole blood have identified micro RNA involved in various metabolic pathways such as glucose and lipid metabolism. Similarly, short-term changes in transcriptome have been correlated with change in metabolic foot print/transcriptome after exercise in competitive elite athletes. Furthermore, whole genome studies using microarray analysis have shown that a single bout of 30-minute exercise significantly alters skeletal muscle gene expression after 1 hour and up to 48 hours following post exercise. Other studies have confirmed these findings revealing major changes in skeletal muscle gene expression occurs after 1 hour.

Previously, the consumption of an herbal tea such as tulsi has been shown to influence metabolic function, however to date no study has shown whether herbal tea consumption exerts any effect on exercise performance or recovery. Elite athletes are a homogenous group of highly trained individuals and ideal to measure effects of herbal tea on exercise performance and cognition.

The relevance of tulsi consumption includes its potential efficacy, along with its cost-effectiveness, wide spread availability, and high safety profile as an adjunct treatment modality for metabolic diseases. This research has also relevance for people with stress and anxiety, metabolic syndrome and athletes who wish to enhance their performance. This will be the first human study on the short terms effects of tulsi tea and the first to compare the mood, cognition and metabolic function after consumption of different beverages.
The objective of the present study is to investigate the acute effects of different beverages on cognition in healthy adults, elite athletes and people with impaired glucose control.

Also, to identify effect of different beverages on mood, blood pressure, and metabolic function as measured by transcriptome analysis in the above three groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64698 0
Prof Marc Cohen
Address 64698 0
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country 64698 0
Australia
Phone 64698 0
+61 3 9925 7440
Fax 64698 0
Email 64698 0
[email protected]
Contact person for public queries
Name 64699 0
Prof Marc Cohen
Address 64699 0
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country 64699 0
Australia
Phone 64699 0
+61 3 9925 7440
Fax 64699 0
Email 64699 0
[email protected]
Contact person for scientific queries
Name 64700 0
Prof marc Cohen
Address 64700 0
RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria
Country 64700 0
Australia
Phone 64700 0
+61 3 9925 7440
Fax 64700 0
Email 64700 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

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