Fish Nutrient Supplementation in High-intensity Functional Training

Exercise Training Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402527
• Other study ID #: AQUABIOPRO-FIT1
• Status: Completed
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dietary Supplements
• Exercise Training

Intervention

Dietary Supplement:
• Fish nutrients
Intake of fish protein, omega-3 fatty acids, and vitamin D
• Whey protein
Intake of whey protein
• Maltodextrin
Intake of maltodextrin

Locations

Country	Name	City	State
Greece	Laboratory of Evaluation of Human Biological Performance	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	European Commission

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 2 days before the beginning of supplementation.
Primary	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.	Within 2 days after the end of supplementation.
Primary	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.	Within 2 days before the beginning of supplementation.
Primary	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.	Within 2 days after the end of supplementation.
Primary	Maximal dynamic strength of shoulder muscles pre-supplementation	Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.	Within 2 weeks before the beginning of supplementation.
Primary	Maximal dynamic strength of shoulder muscles post-supplementation	Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.	Within 2 weeks after the end of supplementation.
Primary	Force-velocity relationship of knee flexors and extensors pre-supplementation	Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.	Within 2 weeks before the beginning of supplementation.
Primary	Force-velocity relationship of knee flexors and extensors post-supplementation	Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.	Within 2 weeks after the end of supplementation.
Primary	Aerobic fitness pre-supplementation	Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.	Within 2 weeks before the beginning of supplementation.
Primary	Aerobic fitness post-supplementation	Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.	Within 2 weeks after the end of supplementation.
Primary	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.	Within 2 weeks before the beginning of supplementation.
Primary	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.	Within 2 weeks after the end of supplementation.
Secondary	Plasma vitamin D concentration pre-supplementation	Vitamin D will be measured by liquid chromatography - mass spectrometry.	Within 2 days before the beginning of supplementation.
Secondary	Plasma vitamin D concentration post-supplementation	Vitamin D will be measured by liquid chromatography - mass spectrometry.	Within 2 days after the end of supplementation.
Secondary	Muscle endurance pre-supplementation	Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.	Within 2 weeks before the beginning of supplementation.
Secondary	Muscle endurance post-supplementation	Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.	Within 2 weeks after the end of supplementation.
Secondary	Force-velocity relationship of shoulder muscles pre-supplementation	Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.	Within 2 weeks before the beginning of supplementation.
Secondary	Force-velocity relationship of shoulder muscles post-supplementation	Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.	Within 2 weeks after the end of supplementation.
Secondary	Full blood count pre-supplementation	Full blood count will be performed by flow cytometry.	Within 2 days before the beginning of supplementation.
Secondary	Full blood count post-supplementation	Full blood count will be performed by flow cytometry.	Within 2 days after the end of supplementation.
Secondary	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.	Within 2 days before the beginning of supplementation.
Secondary	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.	Within 2 days after the end of supplementation.
Secondary	Plasma enzymes pre-supplementation	Creatine kinase and ?-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.	Within 2 days before the beginning of supplementation.
Secondary	Plasma enzymes post-supplementation	Creatine kinase and ?-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.	Within 2 days after the end of supplementation.
Secondary	Hormonal analyses pre-supplementation	Plasma cortisol and testosterone (both in µg/dL) will be measured by immunoluminescence in an automated analyzer.	Within 2 days before the beginning of supplementation.
Secondary	Hormonal analyses post-supplementation	Plasma cortisol and testosterone (both in µg/dL) will be measured by immunoluminescence in an automated analyzer.	Within 2 days after the end of supplementation.
Secondary	Internal load of exercise pre-supplementation	The internal load of exercise will be assessed by telemetric heart rate sensors and software.	Within the first week of supplementation.
Secondary	Internal load of exercise post-supplementation	The internal load of exercise will be assessed by telemetric heart rate sensors and software.	Within the last week of supplementation (week 6).