Fish Nutrient Supplementation in High-intensity Functional Training

NCT05402527 | Completed

• 1 other identifier: AQUABIOPRO-FIT1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Training; Dietary Supplements

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (16)

• 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.

• Muscle endurance pre-supplementation

  Within 2 weeks before the beginning 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.

Study Arms (6)

Fish nutrients - Whey protein - Maltodextrin

OTHER

Participants will receive fish nutrients, whey protein, and maltodextrin in this order.

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.

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.

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.

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.

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.

Dietary Supplement: Fish nutrients; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin

Interventions

Fish nutrients DIETARY_SUPPLEMENT

Intake of fish protein, omega-3 fatty acids, and vitamin D

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 protein DIETARY_SUPPLEMENT

Intake of whey protein

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

Maltodextrin DIETARY_SUPPLEMENT

Intake of maltodextrin

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• European Commission: collaborator

Study Sites (1)

Laboratory of Evaluation of Human Biological Performance

Thessaloniki, 57001, Greece

Location

MeSH Terms

Interventions

Whey Proteins; maltodextrin

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are instructed not to disclose the supplement they are taking to their trainers, investigators, or outcome assessors.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: June 2, 2022
• Study Start: November 8, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

GR (1)