Egg White Supplementation in High-Intensity Functional Training

Exercise Training Clinical Trial

Official title:

Effects of Egg White Supplementation on Body Composition, Physical Performance, and Amino Acid Profile of Individuals Undergoing High-intensity Functional Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05396963
• Other study ID #: EGGPROScience1
• Status: Completed
• Phase: N/A
• Start date: November 1, 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

High-intensity functional training (HIFT), a new version of high-intensity interval training, has gained interest in recent years. HIFT is based on the CrossFit training template and includes multijoint movement patterns via both endurance and strengthening exercises. Research has shown positive effects of HIFT on body composition, cardiorespiratory fitness, and muscle performance of young individuals. The effectiveness of HIFT in higher ages and its protein requirements are less well documented. Protein requirements have been widely investigated in resistance training, where it has been found that protein supplementation may have additive beneficial effects on muscle strength and lean body mass. However, there is a research gap regarding the adaptations to HIFT when combined with protein supplementation.

Thus, the aim of this research is to compare the effects of egg white supplementation, whey protein supplementation (as a positive comparator), and maltodextrin (a carbohydrate as placebo) on body composition, physical performance, and plasma amino acid profile in young and middle-aged trained individuals of both sexes who perform HIFT. Participants will take all three supplements for 6 weeks each, with 2 weeks of washout (no supplementation) in between, in random and counterbalanced order. Researchers will not know the supplementation status of the participants. Participants will receive 0.6 g of protein or placebo per kg body weight daily on top of isoenergetic dietary 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. The HIFT protocol will include multimodal patterns of movement, combining endurance and strengthening exercises with the use of equipment such as Total Resistance eXercise (TRX), Bosu, kettlebells, and barbells.

Participants will undergo measurements of muscle strength, muscle endurance, aerobic capacity, and body composition at the beginning and end of the study, as well as during the two washout periods. Also, plasma amino acids, hematology, biochemistry, and hormones will be measured. Comparison of all these outcome measures between supplements will reveal whether protein supplementation is useful in HIFT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• 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 65 Years

Eligibility

Inclusion Criteria:

• Regular training (mixed endurance and resistance training 3 to 6 times a week, 50 min each session, for the past 4 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 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

• Egg 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 or protein diet

Related Conditions & MeSH terms

• Dietary Supplements
• Exercise Training

Intervention

Dietary Supplement:
• Egg white
Intake of egg white
• 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 (3)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	European Commission, Greek Ministry of Development

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.
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	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 4 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 4 days 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	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.
Primary	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	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 4 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 4 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 4 days before the end 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 4 days after the end of supplementation.
Secondary	Resting metabolic rate pre-supplementation	Resting metabolic rate will be assessed with indirect calorimetry through the measurement of oxygen consumption with a metabolic analyzer.	Within 2 weeks before the beginning of supplementation.
Secondary	Resting metabolic rate post-supplementation	Resting metabolic rate will be assessed with indirect calorimetry through the measurement of oxygen consumption with a metabolic analyzer.	Within 2 weeks after the end of supplementation.
Secondary	Internal load of exercise pre-supplementation	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	Internal load of exercise will be assessed by telemetric heart rate sensors and software	Within the last week of supplementation (week 6).
Secondary	Full blood count pre-supplementation	Full blood count will be performed by flow cytometry	Within 4 days before the beginning of supplementation
Secondary	Full blood count post-supplementation	Full blood count will be performed by flow cytometry	Within 4 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 4 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 4 days 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	Maximal grip strength pre-supplementation	Maximal grip strength will be assessed by a hand dynamometer	Within 2 weeks before the beginning of supplementation
Secondary	Maximal grip strength post-supplementation	Maximal grip strength will be assessed by a hand dynamometer	Within 2 weeks after the end of supplementation.