- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05396963
Egg White Supplementation in High-Intensity Functional Training
Effects of Egg White Supplementation on Body Composition, Physical Performance, and Amino Acid Profile of Individuals Undergoing High-intensity Functional Training
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Thessaloniki, Greece, 57001
- Laboratory of Evaluation of Human Biological Performance
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Egg white - Whey protein - Maltodextrin
Participants will receive egg white, whey protein, and maltodextrin in this order.
|
Intake of whey protein
Intake of maltodextrin
Intake of egg white
|
|
Other: Egg white - Maltodextrin - Whey protein
Participants will receive egg white, maltodextrin, and whey protein in this order.
|
Intake of whey protein
Intake of maltodextrin
Intake of egg white
|
|
Other: Whey protein - Egg white - Maltodextrin
Participants will receive whey protein, egg white, and maltodextrin in this order.
|
Intake of whey protein
Intake of maltodextrin
Intake of egg white
|
|
Other: Whey protein - Maltodextrin - Egg white
Participants will receive whey protein, maltodextrin, and egg white in this order.
|
Intake of whey protein
Intake of maltodextrin
Intake of egg white
|
|
Other: Maltodextrin - Egg white - Whey protein
Participants will receive maltodextrin, egg white, and whey protein in this order.
|
Intake of whey protein
Intake of maltodextrin
Intake of egg white
|
|
Other: Maltodextrin - Whey protein - Egg white
Participants will receive maltodextrin, whey protein, and egg white in this order.
|
Intake of whey protein
Intake of maltodextrin
Intake of egg white
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 2 weeks before the beginning of supplementation.
|
|
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.
|
Within 2 weeks after the end of supplementation.
|
|
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.
|
Within 2 weeks before the beginning of supplementation.
|
|
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.
|
Within 2 weeks after the end of supplementation.
|
|
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.
|
Within 2 weeks before the beginning of supplementation.
|
|
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.
|
Within 2 weeks after the end of supplementation.
|
|
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.
|
Within 2 weeks before the beginning of supplementation.
|
|
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.
|
Within 2 weeks after the end of supplementation.
|
|
Muscle endurance pre-supplementation
Time Frame: Within 2 weeks before the beginning of supplementation.
|
Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.
|
Within 2 weeks before the beginning of supplementation.
|
|
Muscle endurance post-supplementation
Time Frame: Within 2 weeks after the end of supplementation.
|
Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.
|
Within 2 weeks after the end of supplementation.
|
|
Plasma amino acid profile pre-supplementation
Time Frame: Within 4 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.
|
Within 4 days before the beginning of supplementation.
|
|
Plasma amino acid profile post-supplementation
Time Frame: Within 4 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.
|
Within 4 days after the end of supplementation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Force-velocity relationship of shoulder muscles pre-supplementation
Time Frame: Within 2 weeks before the beginning of supplementation.
|
Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.
|
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.
|
Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.
|
Within 2 weeks after the end of supplementation.
|
|
Biochemical analyses pre-supplementation
Time Frame: Within 4 days before the beginning of 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.
|
|
Biochemical analyses post-supplementation
Time Frame: Within 4 days after the end of 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.
|
|
Hormonal analyses pre-supplementation
Time Frame: Within 4 days before the end of 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.
|
|
Hormonal analyses post-supplementation
Time Frame: Within 4 days after the end of 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.
|
|
Resting metabolic rate pre-supplementation
Time Frame: Within 2 weeks before the beginning of 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.
|
|
Resting metabolic rate post-supplementation
Time Frame: Within 2 weeks after the end of 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.
|
|
Internal load of exercise pre-supplementation
Time Frame: Within the first week of supplementation.
|
Internal load of exercise will be assessed by telemetric heart rate sensors and software
|
Within the first week of supplementation.
|
|
Internal load of exercise post-supplementation
Time Frame: Within the last week of supplementation (week 6).
|
Internal load of exercise will be assessed by telemetric heart rate sensors and software
|
Within the last week of supplementation (week 6).
|
|
Full blood count pre-supplementation
Time Frame: Within 4 days before the beginning of supplementation
|
Full blood count will be performed by flow cytometry
|
Within 4 days before the beginning of supplementation
|
|
Full blood count post-supplementation
Time Frame: Within 4 days after the end of supplementation.
|
Full blood count will be performed by flow cytometry
|
Within 4 days after the end of supplementation.
|
|
Plasma enzymes pre-supplementation
Time Frame: Within 4 days before the beginning of supplementation.
|
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer
|
Within 4 days before the beginning of supplementation.
|
|
Plasma enzymes post-supplementation
Time Frame: Within 4 days after the end of supplementation.
|
Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.
|
Within 4 days after the end of supplementation.
|
|
Maximal grip strength pre-supplementation
Time Frame: Within 2 weeks before the beginning of supplementation
|
Maximal grip strength will be assessed by a hand dynamometer
|
Within 2 weeks before the beginning of supplementation
|
|
Maximal grip strength post-supplementation
Time Frame: Within 2 weeks after the end of supplementation.
|
Maximal grip strength will be assessed by a hand dynamometer
|
Within 2 weeks after the end of supplementation.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vassilis Mougios, Aristotle University of Thessaloniki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EGGPROScience1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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