None listed
Conditions
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.
Interventions
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
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.
Sponsors
Professor Marc Cohen
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed