Trial Review

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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
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
Secondary ID [1] 312487 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiorespiratory Fitness 334345 0
Exercise Induced Inflammation 334829 0
Body Composition 334830 0
Condition category
Condition code
Public Health 330992 330992 0 0
Health promotion/education
Metabolic and Endocrine 331386 331386 0 0
Normal metabolism and endocrine development and function
Musculoskeletal 331387 331387 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
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,
Intervention code [1] 329004 0
Lifestyle
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.
Control group
Placebo

Outcomes
Primary outcome [1] 338758 0
Cardiorespiratory fitness
Timepoint [1] 338758 0
Baseline and after the 8-week intervention period
Primary outcome [2] 338759 0
Vertical Jump Performance
Timepoint [2] 338759 0
Baseline and after the 8-week intervention period
Primary outcome [3] 338760 0
Upper Body Strength
Timepoint [3] 338760 0
Baseline and after the 8-week intervention period
Secondary outcome [1] 437362 0
Muscle Endurance
Timepoint [1] 437362 0
Baseline and after the 8-week intervention period
Secondary outcome [2] 438196 0
Anthropometry and Body Composition. This will be assessed as a composite outcome
Timepoint [2] 438196 0
Baseline and after the 8 week intervention period
Secondary outcome [3] 438197 0
Creatine Kinase (CK)
Timepoint [3] 438197 0
At baseline and after the 8-week intervention period
Secondary outcome [4] 438199 0
Fatty Acids composition of Red Blood Cell Membranes Analyses
Timepoint [4] 438199 0
At the end of the 8-week intervention period
Secondary outcome [5] 438200 0
C-Reactive Protein
Timepoint [5] 438200 0
At baseline and after the 8-week intervention period

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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any health problem, taking any medication, or if they were unfamiliar with High Intensity Functional Training

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the lottery method
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/09/2017
Date of last participant enrolment
Anticipated
Actual
29/09/2017
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
20
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 26411 0
Cyprus
State/province [1] 26411 0
Nicosia

Funding & Sponsors
Funding source category [1] 316907 0
Self funded/Unfunded
Name [1] 316907 0
George Posnakidis
Country [1] 316907 0
Cyprus
Primary sponsor type
Individual
Name
George Aphamis, University of Nicosia, Nicosia, Cyprus
Address
Country
Cyprus
Secondary sponsor category [1] 319156 0
None
Name [1] 319156 0
Address [1] 319156 0
Country [1] 319156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315665 0
Cyprus National Bioethics Committee
Ethics committee address [1] 315665 0
Ethics committee country [1] 315665 0
Cyprus
Date submitted for ethics approval [1] 315665 0
09/09/2016
Approval date [1] 315665 0
21/03/2017
Ethics approval number [1] 315665 0
CNBC/2016/56)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135430 0
Dr George Aphamis
Address 135430 0
University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
Country 135430 0
Cyprus
Phone 135430 0
+35722842326
Fax 135430 0
Email 135430 0
aphamis.g@unic.ac.cy
Contact person for public queries
Name 135431 0
George Aphamis
Address 135431 0
University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
Country 135431 0
Cyprus
Phone 135431 0
+35722842326
Fax 135431 0
Email 135431 0
aphamis.g@unic.ac.cy
Contact person for scientific queries
Name 135432 0
George Aphamis
Address 135432 0
University of Nicosia, 46 Makedonitissas Avenue, Nicosia, CY-2417
Country 135432 0
Cyprus
Phone 135432 0
+35722841500
Fax 135432 0
Email 135432 0
aphamis.g@unic.ac.cy

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.