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Trial registered on ANZCTR
Registration number
ACTRN12624001044516
Ethics application status
Approved
Date submitted
11/07/2024
Date registered
28/08/2024
Date last updated
28/08/2024
Date data sharing statement initially provided
28/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of Supplementation with Omega-3 and Omega-6 Poly-unsaturated Fatty Acids and Antioxidant Vitamins, Combined with High-Intensity Functional Training, on Exercise Performance and Body Composition in Healthy Young Adults
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Scientific title
Effects of Supplementation with Omega-3 and Omega-6 Poly-unsaturated Fatty Acids and Antioxidant Vitamins, Combined with High-Intensity Functional Training, on Exercise Performance and Body Composition in Healthy Young Adults: A Randomized, Double-blind, Placebo-Controlled Trial
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Secondary ID [1]
312487
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiorespiratory Fitness
334345
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Exercise Induced Inflammation
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Body Composition
334830
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Condition category
Condition code
Public Health
330992
330992
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0
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Health promotion/education
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Metabolic and Endocrine
331386
331386
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0
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Normal metabolism and endocrine development and function
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Musculoskeletal
331387
331387
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The experimental supplement group (SG, n = 10, 29 ± 6 years, 5 females) trained together with the Placebo Group, three times per week (Monday, Wednesday, and Friday) and followed the same High Intensity Functional Training (HIFT) protocol for 8 weeks. On the week preceding (baseline) and the week following the training period (post-intervention), all participants underwent physical perfor-mance and body composition assessment, including anthropometry, body composition, maximal oxygen uptake (VO2max), upper body strength, flexibility, and muscular en-durance. All tests took place in the morning, except for the bench press maximum strength at 1 Repetition Maximum (1RM) and muscular endurance tests, which took place in the afternoon. The fitness tests took place in the Human Performance Laboratory of the University of Nicosia, in Cyprus, and at the university's gym (UFIT). During each workday of the first and last weeks of the training period, fasting blood samples were drawn to determine CK and CRP concentrations. The fatty acid composition of Red Blood Cell membranes (RBC) was assessed for compliance to the supplemented formulation.
All participants were asked to refrain from strenuous exercise on the day before the tests. Detailed food and fluid intake records were kept for 24 h before their first visit to the lab, and the diet was replicated before the post-training tests. Post-training tests took place at least 72 h following the last training session to allow adequate re-covery.
During the study, the SG consumed a specific supplement formula (20 ml per day for 8 weeks) , rich in eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) (n-3 PUFAs), and linoleic acid (LA) + linolenic acid (GLA) (n-6 PUFAs) with vitamin E and gamma-tocopherol as antioxidant vitamins (Neuroaspis PLP10, Palupa Medical, Nicosia, Cyprus),
The study was approved by the Cyprus National Bioethics Committee, and all participants signed an informed consent form following a written and verbal explanation of the nature, aim, and methods of the study. Attendance to every HIFT session was kept and monitored by the person-member of the team administering the HIFT session,
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Intervention code [1]
329004
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Lifestyle
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Comparator / control treatment
The placebo group (PG, n = 9, 30 ± 3 years, 5 females) followed exactly the same protocol as the Supplement group with regards to fitness testing and HIFT training. The only difference between groups was that the Control Group ingested a Placebo (20ml pure virgin oil) during the 8 weeks of the intervention. Both the supplement and the placebo were in identical bottles and were administrated orally once daily, 30 minutes before dinner. Both the participants and the investigators were blinded as to the content of the bottles.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Cardiorespiratory fitness
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Assessment method [1]
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Cardiorespiratory Fitness
VO2max and maximum heart rate (HRmax) were measured using an incremental running protocol on a level treadmill (h/p/cosmos pulsar 3p; HP Cosmos, Nussdorf-Traunstein, Germany). Starting at 8 km·h-1, running speed was increased every minute by 1 km·h-1 until exhaustion. Oxygen uptake was measured by a breath-by-breath analyzer (Quark CPET; Cosmed, Rome, Italy). Heart rate (HR) was continuously monitored using a telemetric heart rate monitor (H10 Heart Rate sensor; Polar, Kempele, Finland). All subjects achieved a true VO2max, as they met the criteria set by the American College of Sports Medicine (ACSM)
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Timepoint [1]
338758
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Baseline and after the 8-week intervention period
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Primary outcome [2]
338759
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Vertical Jump Performance
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Assessment method [2]
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The participants performed squat jumps (SJ), with hands held firmly at the waist, and countermovement jumps (CMJ), using arm swing. Jump height was measured using Opto Jump Next (Microgate, Bolzano, Italy). Three efforts were allowed for each jump with 1 min rest in between, and the best effort was recorded.
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Timepoint [2]
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Baseline and after the 8-week intervention period
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Primary outcome [3]
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Upper Body Strength
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Assessment method [3]
338760
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Bench press was used to evaluate upper body strength. Since all participants had some experience, an estimate of their 1-repetition maximum (1RM) was used to set the weight for the initial sets of the bench press test. Following a warm-up with low weights, the participants were asked to perform 10 repetitions at 50% of estimated 1RM, followed by 5 repetitions at 75%, and 3 repetitions at 85%. Then the weight was increased gradually by 5 or 2.5 kg, with the participants performing 1 repetition at each weight until true 1RM was achieved. Between sets there was a 4-min rest
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Timepoint [3]
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Baseline and after the 8-week intervention period
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Secondary outcome [1]
437362
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Muscle Endurance
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Assessment method [1]
437362
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Following the determination of their 1RM, the participants were asked to perform as many repetitions as possible at 65% 1RM with the correct technique. The test was terminated when the participants could not lift the bar or their technique failed and they required assistance to lift the bar. The number of repetitions was used as a measure of upper-body muscle endurance.
To determine muscle endurance of the abdominal muscles, the participants were asked to perform as many sit-ups as possible in one minute. Each participant lay on the ground, with knees at a 90° angle, feet held firmly on the ground by an examiner, and arms crossed at the chest.
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Timepoint [1]
437362
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Baseline and after the 8-week intervention period
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Secondary outcome [2]
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Anthropometry and Body Composition. This will be assessed as a composite outcome
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Assessment method [2]
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Height was measured with a stadiometer to the nearest 0.5 cm to calculate body mass index. All other anthropometric and body composition variables, that is, body mass (kg), body fat (%), and lean body mass (kg), were measured with a medical scale and body composition analyzer, based on multi-frequency bioelectrical impedance analysis (Seca mBCA 515; Seca, Chino, CA). All these measurements were taken in the early morning (7 am) in a fasted state. The participants wore only light shorts and a T-shirt.
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Timepoint [2]
438196
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Baseline and after the 8 week intervention period
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Secondary outcome [3]
438197
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Creatine Kinase (CK)
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Assessment method [3]
438197
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During each workday of the first and last weeks of the training period, fasting 7.5-ml venous blood samples were drawn. Of those, 5 ml were dispensed into a plain tube for CK and CRP analyses. The remaining 2.5 ml were dispensed in an EDTA tube for RBC fatty acid.analyses. CRP and CK were measured by a COBAS INTEGRA 400 plus automated analyzer.
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Timepoint [3]
438197
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At baseline and after the 8-week intervention period
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Secondary outcome [4]
438199
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Fatty Acids composition of Red Blood Cell Membranes Analyses
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Assessment method [4]
438199
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During each workday of the last weeksof the training period, fasting 2.5-ml venous blood samples were dispensed in an EDTA tube for RBC fatty acid analyses in order to confirm compliance to the formula consumption. The fatty acid analysis was performed using gas chromatography (GC) by a standard method
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Timepoint [4]
438199
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At the end of the 8-week intervention period
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Secondary outcome [5]
438200
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C-Reactive Protein
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Assessment method [5]
438200
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During each workday of the first and last weeks of the training period, fasting 7.5-ml venous blood samples were drawn. Of those, 5 ml were dispensed into a plain tube for CRP analysis. CRP was measured by a COBAS INTEGRA 400 plus automated analyzer.
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Timepoint [5]
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At baseline and after the 8-week intervention period
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Eligibility
Key inclusion criteria
Due to the demanding nature of HIFT, all participants were familiar with this form of exercise, had at least 6 months of experience in similar exercise programs, and were examined by a medical doctor before joining the study
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Any health problem, taking any medication, or if they were unfamiliar with High Intensity Functional Training
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the lottery method
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All statistical analyses were performed using SPSS for Windows, v.24.0 (IBM, Ar-monk, NY). Descriptive data are presented as the mean ± SD. A two-way, time × group, analysis of variance (ANOVA) with repeated measures on time was used to compare anthropometric, body composition, and performance variables before and after the exercise and nutritional interventions between groups. Additionally, a three-way, week × day × group, ANOVA with repeated measures on week and day was used to analyze CK and CRP values. When a significant interaction was found, the Tukey’s post-hoc test was used to locate significant differences. Student’s t-test was used for the fatty acid analyses. The level of statistical significance was set at a = 0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
4/09/2017
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Date of last participant enrolment
Anticipated
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Actual
29/09/2017
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Date of last data collection
Anticipated
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Actual
1/12/2017
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Sample size
Target
20
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Accrual to date
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Final
19
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Recruitment outside Australia
Country [1]
26411
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Cyprus
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State/province [1]
26411
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Nicosia
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Funding & Sponsors
Funding source category [1]
316907
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Self funded/Unfunded
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Name [1]
316907
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George Posnakidis
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Address [1]
316907
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Country [1]
316907
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Cyprus
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Primary sponsor type
Individual
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Name
George Aphamis, University of Nicosia, Nicosia, Cyprus
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Address
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Country
Cyprus
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Secondary sponsor category [1]
319156
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None
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Name [1]
319156
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Address [1]
319156
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Country [1]
319156
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315665
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Cyprus National Bioethics Committee
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Ethics committee address [1]
315665
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22 Laertou Str., Ayios Dometios, Nicosia, CY-2365, Cyprus
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Ethics committee country [1]
315665
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Cyprus
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Date submitted for ethics approval [1]
315665
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09/09/2016
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Approval date [1]
315665
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21/03/2017
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Ethics approval number [1]
315665
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CNBC/2016/56)
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Summary
Brief summary
High Intensity Functional Training (HIFT) is a popular mode of exercise in gym centers. High intensity could potentially induce some inflammation. Omega fatty acids have been shown to reduce exercise-induced inflammation. The purpose of the trial was to investigate whether supplementation with omega fatty acids and antioxidant vitamins would further improve the training outcome of an 8-week HIFT training period. This study aimed to investigate whether the combination of HIFT exercise, omega fatty acids and antioxidant vitamins supplementation would further improve fitness, body composition and decrease exercise-induced inflammation in healthy adults.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr George Aphamis
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Address
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University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
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Country
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Cyprus
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Phone
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+35722842326
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
135431
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George Aphamis
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Address
135431
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University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
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Country
135431
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Cyprus
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Phone
135431
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+35722842326
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Fax
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Email
135431
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[email protected]
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Contact person for scientific queries
Name
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George Aphamis
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Address
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University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
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Country
135432
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Cyprus
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Phone
135432
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+35722841500
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Fax
135432
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Email
135432
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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