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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]

NIL

Universal Trial Number (UTN)

U1111-1181-3466

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cognition

metabolic syndrome

mood

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Metabolic and Endocrine

Metabolic disorders

Mental Health

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]

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]

Cognitive Function assessed using CogState computerized battery

Timepoint [1]

at baseline, after 60minutes following treatment (T60)

Secondary outcome [1]

blood pressure measured by an oscillometric device

Timepoint [1]

baseline, at 1 hour (T1), 2 hours (T2) and 4 hours (T4)

Secondary outcome [2]

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]

test will be conducted at base line and at 1 hour post intervention

Secondary outcome [3]

Aerobic Capacity testing (VO2). This outcome will be measured using beep test

Timepoint [3]

measured only 30 minutes after intervention (T30)

Secondary outcome [4]

fasting blood glucose levels

Timepoint [4]

measured at baseline and after 60minutes post intervention

Secondary outcome [5]

RNA transcriptome analysis of blood samples

Timepoint [5]

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]

3000 - Melbourne

Recruitment postcode(s) [2]

3083 - Bundoora

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT

Address [1]

Plenty road, Bundoora 3083

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

RMIT UNIVERSITY HUMAN RESEARCH ETHICS COMMITEE

Ethics committee address [1]

Plenty Road
Bundoora
VIC
3083

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2016

Approval date [1]

Ethics approval number [1]

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

Prof Marc Cohen

Address

RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria

Country

Australia

Phone

+61 3 9925 7440

Fax

[email protected]

Contact person for public queries

Name

Marc Cohen

Address

RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria

Country

Australia

Phone

+61 3 9925 7440

Fax

[email protected]

Contact person for scientific queries

Name

marc Cohen

Address

RMIT University
Plenty road, Bundoora Campus
School of Health and Biomedical Sciences
Bundoora 3083
Victoria

Country

Australia

Phone

+61 3 9925 7440

Fax

[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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