Exercise TrainingNCT05402527
Fish Nutrient Supplementation in High-intensity Functional Training
A study testing Fish nutrients, Whey protein and Maltodextrin in people with Exercise Training and Dietary Supplements, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Nowadays, many persons who exercise consume dietary supplements. Previous scientific studies have found that protein supplementation increases muscle mass when combined with an exercise program. In addition, vitamin D probably improves performance and muscle function. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Dietary Supplements
- What is being tested?
- Fish nutrients, Whey protein and Maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- 8 Nov 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular training (mixed endurance and resistance training 3-6 times a week, 50 min each session, for the past 4-6 months) as assessed by gym records or questionnaires.
- Clearance from a pathologist or cardiologist to perform maximal exercise.
- Mixed isoenergetic diet for the past 4-6 months.
Who cannot join
- Smoking (even one cigarette or nicotine-containing device over the past 6 months).
- Any injuries to the musculoskeletal system that could interfere with the execution of training.
- Chronic disease.
- Fish or oyster allergy.
- Milk allergy.
- Pregnancy, lactation or planning a pregnancy within the duration of the study.
Show all 9Show fewer
- Regular use of prescription medicine or supplements that might affect muscle function or recovery over the past month.
- Intermittent or religious fasting.
- Any vegetarian, ketogenic and protein diet.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Evaluation of Human Biological Performance
Thessaloniki, 57001
About this study
Official title: Effects of a Nutritional Supplement of Proteins, ω3 Fatty Acids and Vitamin D on Physical Performance, Body Composition and Biochemical Profile of Persons Following High-intensity Functional Training
Nowadays, many persons who exercise consume dietary supplements. Previous scientific studies have found that protein supplementation increases muscle mass when combined with an exercise program. In addition, vitamin D probably improves performance and muscle function. Likewise, ω3 fatty acids, apart from improving cardiovascular function, may also increase protein synthesis and performance. Thus, the aim of this study is to investigate the efficacy of a novel aquaculture-based sport supplement of proteins, ω3 fatty acids and vitamin D on physical performance, body composition, and the biochemical profile of persons following high-intensity functional training (HIFT). The efficacy of the experimental supplement (E) will be compared with whey protein (W) and maltodextrin (a carbohydrate) as placebo (P).
Thirty healthy trained individuals (15 male and 15 female), aged 18-35, will take E, W, and P during three 6-week periods of HIFT (a different supplement each period) with three workouts a week and a washout (no supplement) period of 2 weeks between supplementation periods. E is a combination of powder, containing protein and vitamin D, and capsules containing ω3 fatty acids. When on E, participants will receive 0.6 g protein/kg body weight, 20 μg vitamin D, and 1.8 g ω3 fatty acids daily. When on W, they will receive 0.6 g protein/kg body weight and, when on P, they will receive 0.6 g maltodextrin/kg body weight daily. The order of E, W, and P will be random and counterbalanced. Throughout the study, participants will be on isoenergetic nutritional plans to avoid differences in energy intake that might compromise the validity of the study. The dietary plans will be individualized and will provided 1.0 g protein/kg body weight/day.
Read more
Participants will undergo measurements of muscle strength, muscle endurance, aerobic capacity, and body composition prior to the first supplementation period, between periods, and after the third period. Also, blood amino acids, fatty acid acids, vitamin D, hematology, biochemistry, and hormones will be measured. To avoid bias, assessors will not know which supplement each participant is taking during each period.
The main hypotheses of the study are: 1) Consumption of E will increase lean body mass compared to W and P; 2) consumption of E will improve muscle strength, muscle endurance, and aerobic capacity compared to W and P; and 3) consumption of E will result in a better blood amino acid, fatty acid, and vitamin D profile.
- Conditions
- Exercise Training, Dietary Supplements
- Being tested
- Fish nutrients, Whey protein, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish nutrientsDietary supplement
Intake of fish protein, omega-3 fatty acids, and vitamin D
Whey proteinDietary supplement
Intake of whey protein
MaltodextrinDietary supplement
Intake of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Fish nutrients - Whey protein - Maltodextrin | Other | Participants will receive fish nutrients, whey protein, and maltodextrin in this order. Receives: Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin |
| Fish nutrients - Maltodextrin - Whey protein | Other | Participants will receive fish nutrients, maltodextrin, and whey protein in this order. Receives: Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin |
| Whey protein - Fish nutrients - Maltodextrin | Other | Participants will receive whey protein, fish nutrients, and maltodextrin in this order. Receives: Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin |
| Whey protein - Maltodextrin - Fish nutrients | Other | Participants will receive whey protein, maltodextrin, and fish nutrients in this order. Receives: Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin |
| Maltodextrin - Fish nutrients - Whey protein | Other | Participants will receive maltodextrin, fish nutrients, and whey protein in this order. Receives: Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin |
| Maltodextrin - Whey protein - Fish nutrients | Other | Participants will receive maltodextrin, whey protein, and fish nutrients in this order. Receives: Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid profile pre-supplementation
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography - mass spectrometry.
Measured: Within 2 days before the beginning of supplementation.
Plasma amino acid profile post-supplementation
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography - mass spectrometry.
Measured: Within 2 days after the end of supplementation.
Whole-blood fatty acid profile pre-supplementation
Whole-blood fatty acid profile (that is, the concentration of each individual fatty acid) will be determined by gas chromatography.
Measured: Within 2 days before the beginning of supplementation.
Whole-blood fatty acid profile post-supplementation
Whole-blood fatty acid profile (that is, the concentration of each individual fatty acid) will be determined by gas chromatography.
Measured: Within 2 days after the end of supplementation.
Maximal dynamic strength of shoulder muscles pre-supplementation
Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.
Measured: Within 2 weeks before the beginning of supplementation.
Maximal dynamic strength of shoulder muscles post-supplementation
Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.
Measured: Within 2 weeks after the end of supplementation.
Force-velocity relationship of knee flexors and extensors pre-supplementation
Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.
Measured: Within 2 weeks before the beginning of supplementation.
Force-velocity relationship of knee flexors and extensors post-supplementation
Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.
Measured: Within 2 weeks after the end of supplementation.
Aerobic fitness pre-supplementation
Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.
Measured: Within 2 weeks before the beginning of supplementation.
Aerobic fitness post-supplementation
Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.
Measured: Within 2 weeks after the end of supplementation.
Lean and fat mass pre-supplementation
Lean and fat mass of the whole body and its parts (trunk, legs and arms) will be assessed by dual X-ray absorptiometry.
Measured: Within 2 weeks before the beginning of supplementation.
Lean and fat mass post-supplementation
Lean and fat mass of the whole body and its parts (trunk, legs and arms) will be assessed by dual X-ray absorptiometry.
Measured: Within 2 weeks after the end of supplementation.
Secondary outcomes (16)
Plasma vitamin D concentration pre-supplementation
Vitamin D will be measured by liquid chromatography - mass spectrometry.
Measured: Within 2 days before the beginning of supplementation.
Plasma vitamin D concentration post-supplementation
Vitamin D will be measured by liquid chromatography - mass spectrometry.
Measured: Within 2 days after the end of supplementation.
Muscle endurance pre-supplementation
Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.
Measured: Within 2 weeks before the beginning of supplementation.
Muscle endurance post-supplementation
Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.
Measured: Within 2 weeks after the end of supplementation.
Force-velocity relationship of shoulder muscles pre-supplementation
Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.
Measured: Within 2 weeks before the beginning of supplementation.
Force-velocity relationship of shoulder muscles post-supplementation
Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.
Measured: Within 2 weeks after the end of supplementation.
Full blood count pre-supplementation
Full blood count will be performed by flow cytometry.
Measured: Within 2 days before the beginning of supplementation.
Full blood count post-supplementation
Full blood count will be performed by flow cytometry.
Measured: Within 2 days after the end of supplementation.
Biochemical analyses pre-supplementation
Plasma glucose, triacylglycerols, total cholesterol, HDL cholesterol, LDL cholesterol, urea, and creatinine (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Measured: Within 2 days before the beginning of supplementation.
Biochemical analyses post-supplementation
Plasma glucose, triacylglycerols, total cholesterol, HDL cholesterol, LDL cholesterol, urea, and creatinine (all in mg/dL) will be measured by chemiluminescence in an automated analyzer.
Measured: Within 2 days after the end of supplementation.
Plasma enzymes pre-supplementation
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.
Measured: Within 2 days before the beginning of supplementation.
Plasma enzymes post-supplementation
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.
Measured: Within 2 days after the end of supplementation.
Hormonal analyses pre-supplementation
Plasma cortisol and testosterone (both in μg/dL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within 2 days before the beginning of supplementation.
Hormonal analyses post-supplementation
Plasma cortisol and testosterone (both in μg/dL) will be measured by immunoluminescence in an automated analyzer.
Measured: Within 2 days after the end of supplementation.
Internal load of exercise pre-supplementation
The internal load of exercise will be assessed by telemetric heart rate sensors and software.
Measured: Within the first week of supplementation.
Internal load of exercise post-supplementation
The internal load of exercise will be assessed by telemetric heart rate sensors and software.
Measured: Within the last week of supplementation (week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start8 Nov 2021
- Primary completion31 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402527
- Sponsor's protocol ID
- AQUABIOPRO-FIT1
- Status last verified
- Oct 2023
- First submitted
- 22 Apr 2022
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kosmidis I, Karpouzi C, Petridou A, Voulgaridou G, Bogdanis GC, Mougios V. Effects of a nutritional supplement containing fish protein, vitamin D, and omega3 fatty acids, taken during high-intensity functional training, on physical performance in recreationally trained individuals: a randomized controlled trial. Eur J Nutr. 2026 May 26;65(4):136. doi: 10.1007/s00394-026-03983-z.
PubMed 42189275
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Nutritional Supplement of Proteins, ω3 Fatty Acids and Vitamin D on Physical Performance, Body Composition and Biochemical Profile of Persons Following High-intensity Functional Training
- ClinicalTrials.gov ID
- NCT05402527
- Acronym / sponsor ID
- AQUABIOPRO-FIT1
- Conditions
- Exercise Training, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays, many persons who exercise consume dietary supplements. Previous scientific studies have found that protein supplementation increases muscle mass when combined with an exercise program. In addition, vitamin D probably improves performance and muscle function. Likewise, ω3 fatty acids, apart from improving cardiovascular function, may also increase protein synthesis and performance. Thus, the aim of this study is to investigate the efficacy of a novel aquaculture-based sport supplement of proteins, ω3 fatty acids and vitamin D on physical performance, body composition, and the biochemical profile of persons following high-intensity functional training (HIFT). The efficacy of the experimental supplement (E) will be compared with whey protein (W) and maltodextrin (a carbohydrate) as placebo (P).
Thirty healthy trained individuals (15 male and 15 female), aged 18-35, will take E, W, and P during three 6-week periods of HIFT (a different supplement each period) with three workouts a week and a washout (no supplement) period of 2 weeks between supplementation periods. E is a combination of powder, containing protein and vitamin D, and capsules containing ω3 fatty acids. When on E, participants will receive 0.6 g protein/kg body weight, 20 μg vitamin D, and 1.8 g ω3 fatty acids daily. When on W, they will receive 0.6 g protein/kg body weight and, when on P, they will receive 0.6 g maltodextrin/kg body weight daily. The order of E, W, and P will be random and counterbalanced. Throughout the study, participants will be on isoenergetic nutritional plans to avoid differences in energy intake that might compromise the validity of the study. The dietary plans will be individualized and will provided 1.0 g protein/kg body weight/day.
Participants will undergo measurements of muscle strength, muscle endurance, aerobic capacity, and body composition prior to the first supplementation period, between periods, and after the third period. Also, blood amino acids, fatty acid acids, vitamin D, hematology, biochemistry, and hormones will be measured. To avoid bias, assessors will not know which supplement each participant is taking during each period.
The main hypotheses of the study are: 1) Consumption of E will increase lean body mass compared to W and P; 2) consumption of E will improve muscle strength, muscle endurance, and aerobic capacity compared to W and P; and 3) consumption of E will result in a better blood amino acid, fatty acid, and vitamin D profile.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fish nutrients - Whey protein - Maltodextrin | Other | Dietary Supplement: Fish nutrients, Dietary Supplement: Whey protein, Dietary Supplement: MaltodextrinParticipants will receive fish nutrients, whey protein, and maltodextrin in this order. |
| Fish nutrients - Maltodextrin - Whey protein | Other | Dietary Supplement: Fish nutrients, Dietary Supplement: Whey protein, Dietary Supplement: MaltodextrinParticipants will receive fish nutrients, maltodextrin, and whey protein in this order. |
| Whey protein - Fish nutrients - Maltodextrin | Other | Dietary Supplement: Fish nutrients, Dietary Supplement: Whey protein, Dietary Supplement: MaltodextrinParticipants will receive whey protein, fish nutrients, and maltodextrin in this order. |
| Whey protein - Maltodextrin - Fish nutrients | Other | Dietary Supplement: Fish nutrients, Dietary Supplement: Whey protein, Dietary Supplement: MaltodextrinParticipants will receive whey protein, maltodextrin, and fish nutrients in this order. |
| Maltodextrin - Fish nutrients - Whey protein | Other | Dietary Supplement: Fish nutrients, Dietary Supplement: Whey protein, Dietary Supplement: MaltodextrinParticipants will receive maltodextrin, fish nutrients, and whey protein in this order. |
| Maltodextrin - Whey protein - Fish nutrients | Other | Dietary Supplement: Fish nutrients, Dietary Supplement: Whey protein, Dietary Supplement: MaltodextrinParticipants will receive maltodextrin, whey protein, and fish nutrients in this order. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Regular training (mixed endurance and resistance training 3-6 times a week, 50 min each session, for the past 4-6 months) as assessed by gym records or questionnaires.
- Clearance from a pathologist or cardiologist to perform maximal exercise.
- Mixed isoenergetic diet for the past 4-6 months.
Key exclusion criteria (9 listed)
- Smoking (even one cigarette or nicotine-containing device over the past 6 months).
- Any injuries to the musculoskeletal system that could interfere with the execution of training.
- Chronic disease.
- Fish or oyster allergy.
- Milk allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish nutrientsIntake of fish protein, omega-3 fatty acids, and vitamin D | Dietary supplement | Fish nutrients - Maltodextrin - Whey protein, Fish nutrients - Whey protein - Maltodextrin, Maltodextrin - Fish nutrients - Whey protein, Maltodextrin - Whey protein - Fish nutrients, Whey protein - Fish nutrients - Maltodextrin, Whey protein - Maltodextrin - Fish nutrients |
| Whey proteinIntake of whey protein | Dietary supplement | Fish nutrients - Maltodextrin - Whey protein, Fish nutrients - Whey protein - Maltodextrin, Maltodextrin - Fish nutrients - Whey protein, Maltodextrin - Whey protein - Fish nutrients, Whey protein - Fish nutrients - Maltodextrin, Whey protein - Maltodextrin - Fish nutrients |
| MaltodextrinIntake of maltodextrin | Dietary supplement | Fish nutrients - Maltodextrin - Whey protein, Fish nutrients - Whey protein - Maltodextrin, Maltodextrin - Fish nutrients - Whey protein, Maltodextrin - Whey protein - Fish nutrients, Whey protein - Fish nutrients - Maltodextrin, Whey protein - Maltodextrin - Fish nutrients |
Primary outcome
Plasma amino acid profile pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography - mass spectrometry.
Plasma amino acid profile post-supplementation
Time frame: Within 2 days after the end of supplementation.
Plasma amino acid profile (that is, the concentration of each individual amino acid) will be determined by liquid chromatography - mass spectrometry.
Whole-blood fatty acid profile pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Whole-blood fatty acid profile (that is, the concentration of each individual fatty acid) will be determined by gas chromatography.
Whole-blood fatty acid profile post-supplementation
Time frame: Within 2 days after the end of supplementation.
Whole-blood fatty acid profile (that is, the concentration of each individual fatty acid) will be determined by gas chromatography.
Maximal dynamic strength of shoulder muscles pre-supplementation
Time frame: Within 2 weeks before the beginning of supplementation.
Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.
Maximal dynamic strength of shoulder muscles post-supplementation
Time frame: Within 2 weeks after the end of supplementation.
Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.
Force-velocity relationship of knee flexors and extensors pre-supplementation
Time frame: Within 2 weeks before the beginning of supplementation.
Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.
Force-velocity relationship of knee flexors and extensors post-supplementation
Time frame: Within 2 weeks after the end of supplementation.
Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.
Aerobic fitness pre-supplementation
Time frame: Within 2 weeks before the beginning of supplementation.
Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.
Aerobic fitness post-supplementation
Time frame: Within 2 weeks after the end of supplementation.
Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.
Lean and fat mass pre-supplementation
Time frame: Within 2 weeks before the beginning of supplementation.
Lean and fat mass of the whole body and its parts (trunk, legs and arms) will be assessed by dual X-ray absorptiometry.
Lean and fat mass post-supplementation
Time frame: Within 2 weeks after the end of supplementation.
Lean and fat mass of the whole body and its parts (trunk, legs and arms) will be assessed by dual X-ray absorptiometry.
16 secondary outcomes
Plasma vitamin D concentration pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Plasma vitamin D concentration post-supplementation
Time frame: Within 2 days after the end of supplementation.
Muscle endurance pre-supplementation
Time frame: Within 2 weeks before the beginning of supplementation.
Muscle endurance post-supplementation
Time frame: Within 2 weeks after the end of supplementation.
Force-velocity relationship of shoulder muscles pre-supplementation
Time frame: Within 2 weeks before the beginning of supplementation.
Force-velocity relationship of shoulder muscles post-supplementation
Time frame: Within 2 weeks after the end of supplementation.
Full blood count pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Full blood count post-supplementation
Time frame: Within 2 days after the end of supplementation.
Biochemical analyses pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Biochemical analyses post-supplementation
Time frame: Within 2 days after the end of supplementation.
Plasma enzymes pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Plasma enzymes post-supplementation
Time frame: Within 2 days after the end of supplementation.
Hormonal analyses pre-supplementation
Time frame: Within 2 days before the beginning of supplementation.
Hormonal analyses post-supplementation
Time frame: Within 2 days after the end of supplementation.
Internal load of exercise pre-supplementation
Time frame: Within the first week of supplementation.
Internal load of exercise post-supplementation
Time frame: Within the last week of supplementation (week 6).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 42189275Kosmidis I, Karpouzi C, Petridou A, Voulgaridou G, Bogdanis GC, Mougios V. Effects of a nutritional supplement containing fish protein, vitamin D, and omega3 fatty acids, taken during high-intensity functional training, on physical performance in recreationally trained individuals: a randomized controlled trial. Eur J Nutr. 2026 May 26;65(4):136. doi: 10.1007/s00394-026-03983-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish nutrients, Whey protein and Maltodextrin in people with Exercise Training and Dietary Supplements, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma amino acid profile pre-supplementation (time frame: Within 2 days before the beginning of supplementation.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.