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Clinical Trials/NCT05402527
NCT05402527
Completed
Not Applicable

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

Aristotle University Of Thessaloniki1 site in 1 country25 target enrollmentNovember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise Training
Sponsor
Aristotle University Of Thessaloniki
Enrollment
25
Locations
1
Primary Endpoint
Plasma amino acid profile post-supplementation
Status
Completed
Last Updated
2 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
November 8, 2021
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • 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.

Outcomes

Primary Outcomes

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • Muscle endurance pre-supplementation(Within 2 weeks before the beginning of supplementation.)
  • Biochemical analyses post-supplementation(Within 2 days after the end of supplementation.)
  • Plasma enzymes post-supplementation(Within 2 days after the end of supplementation.)
  • Hormonal analyses pre-supplementation(Within 2 days before the beginning of supplementation.)
  • Plasma vitamin D concentration pre-supplementation(Within 2 days before the beginning of supplementation.)
  • Plasma vitamin D concentration post-supplementation(Within 2 days after the end of supplementation.)
  • Full blood count post-supplementation(Within 2 days after the end of supplementation.)
  • Hormonal analyses post-supplementation(Within 2 days after the end of supplementation.)
  • Muscle endurance post-supplementation(Within 2 weeks after the end of supplementation.)
  • Force-velocity relationship of shoulder muscles pre-supplementation(Within 2 weeks before the beginning of supplementation.)
  • Force-velocity relationship of shoulder muscles post-supplementation(Within 2 weeks after the end of supplementation.)
  • Full blood count pre-supplementation(Within 2 days before the beginning of supplementation.)
  • Biochemical analyses pre-supplementation(Within 2 days before the beginning of supplementation.)
  • Plasma enzymes pre-supplementation(Within 2 days before the beginning of supplementation.)
  • Internal load of exercise pre-supplementation(Within the first week of supplementation.)
  • Internal load of exercise post-supplementation(Within the last week of supplementation (week 6).)

Study Sites (1)

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