Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000815167
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
4/06/2019
Date last updated
8/06/2021
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of the functional food product L-THE containing whey protein mango sorbet on physiological responses and saccadic eye movements
Scientific title
The effects of the functional food product L-THE containing whey protein mango sorbet on physiological responses and saccadic eye movements
Secondary ID [1] 297424 0
N/A
Universal Trial Number (UTN)
U1111-1228-6809
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Pressure 311598 0
Eye Function 311599 0
Condition category
Condition code
Cardiovascular 310227 310227 0 0
Hypertension
Eye 310228 310228 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313680 0
Treatment: Other
Comparator / control treatment
The administered mango sorbet will contain 200mg of L-theanine incorporated into a 100g mango sorbet containing whey protein concentrate, erythritol and mangoes (Treatment).
The placebo version of mango sorbet, will be used as a control and it will contain all ingredients as above except the L-theanine. For the baseline measurements, no mango sorbet will be administered in order to obtain the participants baseline measurements.
The active capsule will contain 200mg of L-theanine while placebo capsule will contain microcrystalline cellulose filler without any L-theanine.
Control group
Placebo

Outcomes
Primary outcome [1] 319111 0
Any potential changes in the blood pressure determined using the digital blood pressure monitor as well as non invasive continuous BP cuff.
Timepoint [1] 319111 0
Primary time points will be continuous (at 30 min intervals) up to 90 minutes since the consumption of the products.
Primary outcome [2] 319762 0
Any potential changes in the heart rate and/or heart rate variability determined using the digital heart rate belt (Suunto/Garmin)
Timepoint [2] 319762 0
Primary time points will be continuous up to 90 minutes after the consumption of products.
Primary outcome [3] 319764 0
Any potential changes in visual acuity determined using standardized optometry charts.
Timepoint [3] 319764 0
Changes in visual acuity and contrast sensitivity can occur after the consumption of number of different food products such as ones containing L-theanine. Participants will be tested for any changes in visual acuity and contrast sensitivity in 15 minute intervals up to 90 minutes post consumption of food products.
Secondary outcome [1] 369447 0
Salivary cortisol
Timepoint [1] 369447 0
Saliva samples will be collected at each 30 minute interval (total of 4 samples) up to 90 minutes post consumption of food products
Secondary outcome [2] 369449 0
Any potential changes in Saccadic eye movements
Timepoint [2] 369449 0
Saccadic eye tests will occur at each designated 15 minutes interval up to 90 minutes post consumption of food products.
Secondary outcome [3] 371101 0
Any potential changes in contrast sensitivity determined using standardized optometry charts.
Timepoint [3] 371101 0
Any potential changes in contrast sensitivity tests that might occur at each designated 15 minutes interval up to 90 minutes post consumption of food products.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

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)
The person randomising the patients will not know what the next treatment allocation will be. This is important as it prevents selection bias affecting which patients are given which treatment .

Method of allocation will be located within a sealed envelope only broken when they study is completed (all participants data up to 21 participants) is final.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be undertaken using a randomised sequence generation software
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
SPSS will be used as the primary analysis software.

Repeaset measure ANOVA will be used to conduct variance between subjects and time points
T test analysis will be used to distiguish and specific time point interaction
Area under the curve and F-Test will further be used as a post hoc method to determine the effectiveness over a period of time

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial was completed earlier due to the current COVID-19 health situation and associated risks.
Date of first participant enrolment
Anticipated
1/07/2019
Actual
1/07/2019
Date of last participant enrolment
Anticipated
1/12/2019
Actual
20/03/2020
Date of last data collection
Anticipated
31/12/2019
Actual
31/03/2020
Sample size
Target
21
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 13162 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 25717 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 301995 0
University
Name [1] 301995 0
University of Canberra PhD student Allocation
Country [1] 301995 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra, University Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 301775 0
None
Name [1] 301775 0
Address [1] 301775 0
Country [1] 301775 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302670 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 302670 0
Building 1/11 Kirinari St, Bruce ACT 2617
Ethics committee country [1] 302670 0
Australia
Date submitted for ethics approval [1] 302670 0
15/11/2018
Approval date [1] 302670 0
07/02/2019
Ethics approval number [1] 302670 0
20181534

Summary
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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 91010 0
A/Prof Nenad Naumovski
Address 91010 0
PO Box 5018; University of Canberra, Bruce, 2617, ACT, Australia
Country 91010 0
Australia
Phone 91010 0
+61 2 6206 8719
Fax 91010 0
Email 91010 0
[email protected]
Contact person for public queries
Name 91011 0
Mr Jackson Williams
Address 91011 0
PO Box 5018; University of Canberra, Bruce, 2617, ACT, Australia
Country 91011 0
Australia
Phone 91011 0
+61 0422551122
Fax 91011 0
Email 91011 0
[email protected]
Contact person for scientific queries
Name 91012 0
A/Prof Nenad Naumovski
Address 91012 0
PO Box 5018; University of Canberra, Bruce, 2617, ACT, Australia
Country 91012 0
Australia
Phone 91012 0
+61 2 6206 8719
Fax 91012 0
Email 91012 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.