None listed
Conditions
Brief summary
Based on the findings of the current literature and our research team, the aim of this project is to perform a comparative analysis of physiological and visual responses in healthy humans after the oral administration of L-THE in a capsule form vs. L-THE embedded within the food matrix (0.2g/100g serve mango sorbet). This includes testing the effects of L-THE on saccadic eye movements, visual acuity, contrast sensitivity, heart rate (HR) variability, blood pressure, and the stress response via salivary biomarkers. HR variability and blood pressure has previously been shown in clinical populations, athletes and other healthy people to be a very good predictor of health status, inflammation and fatigue. As well as this, testing saccadic eye movements and salivary cortisol has shown to be a good indicator of alertness and stress levels in the human body.
Interventions
This study is designed as randomized, double-blind, placebo-controlled, crossover trial. The L-Theanine (200mg) will be provided to participants embedded within the food matrix (mango sorbet 200mg/100g w/w) or in a capsule form (200mg).
Trial products, two containing 200mg of L-theanine (mango sorbet and capsule) and two containing placebo (mango sorbet and capsule) will be consumed in four separate clinics (1 product per clinic) with at least one week washout period between each clinic.
The f
This study is designed as randomized, double-blind, placebo-controlled, crossover trial. The L-Theanine (200mg) will be provided to participants embedded within the food matrix (mango sorbet 200mg/100g w/w) or in a capsule form (200mg). Trial products, two containing 200mg of L-theanine (mango sorbet and capsule) and two containing placebo (mango sorbet and capsule) will be consumed in four separate clinics (1 product per clinic) with at least one week washout period between each clinic. The format of the clinics as well as the measurements taken are listed below Participants will attend 5 clinics in total; one information (15min) and four product administration (up to 120min each) clinics. For a three days prior to each product administration clinic, participants will determine morning resting heart rate using heart rate belt by wearing it for 10min immediately upon waking up. The product administration clinics will, in a random order, include consumption of 100g of mango sorbet (containing placebo or 200mg of L-Theanine) or capsule (containing placebo or 200mg of L-Theanine) after an overnight fast. In this clinics, participants will provide saliva sample (passive drool) while blood pressure and heart rate measurements will be taken. Additionally, participants will be exposed to a series of visual tests including visual acuity, contrast sensitivity and measurements of eye saccadic movements after the consumption of the provided products at the designated time intervals. All measurements are non-invasive.
Sponsors
University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Criteria for inclusion required the participants to not be consuming functional foods including cholesterol lowering margarine or if they consume weight loss supplements or commercial dietary products associated with weight loss.
Exclusion criteria
Participants were also excluded if they are suffering or have suffered from the any active pulmonary, hematologic, hepatic, gastrointestinal, renal, premalignant, malignant illnesses or have diabetes (type I and type II) or have any thyroid dysfunction. Participants were also excluded dependent on whether they have or had had any pre existing eye diseases or conditions that have affected their sight.
Outcome results
None listed