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Exercise TrainingNCT05396963

Egg White Supplementation in High-Intensity Functional Training

A study testing Egg white, Whey protein and Maltodextrin in people with Exercise Training and Dietary Supplements, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Training, Dietary Supplements
What is being tested?
Egg white, Whey protein and Maltodextrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGreece
Study dates
1 Nov 2021to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Laboratory of Evaluation of Human Biological Performance

    Thessaloniki, 57001

Other trials in Greece

About this study

Official title: 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.

Being tested
Egg white, Whey protein, Maltodextrin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Egg whiteDietary supplement

    Intake of egg white

  • Whey proteinDietary supplement

    Intake of whey protein

  • MaltodextrinDietary supplement

    Intake of maltodextrin

Study groups in NCT05396963
Study groupRoleWhat they receive
Egg white - Whey protein - MaltodextrinOtherParticipants will receive egg white, whey protein, and maltodextrin in this order.
Receives: Dietary Supplement: Egg white; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin
Egg white - Maltodextrin - Whey proteinOtherParticipants will receive egg white, maltodextrin, and whey protein in this order.
Receives: Dietary Supplement: Egg white; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin
Whey protein - Egg white - MaltodextrinOtherParticipants will receive whey protein, egg white, and maltodextrin in this order.
Receives: Dietary Supplement: Egg white; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin
Whey protein - Maltodextrin - Egg whiteOtherParticipants will receive whey protein, maltodextrin, and egg white in this order.
Receives: Dietary Supplement: Egg white; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin
Maltodextrin - Egg white - Whey proteinOtherParticipants will receive maltodextrin, egg white, and whey protein in this order.
Receives: Dietary Supplement: Egg white; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin
Maltodextrin - Whey protein - Egg whiteOtherParticipants will receive maltodextrin, whey protein, and egg white in this order.
Receives: Dietary Supplement: Egg white; Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 2 weeks before the beginning of supplementation.

  2. 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.

    Measured: Within 2 weeks after the end of supplementation.

  3. Maximal dynamic strength of shoulder muscles pre-supplementation

    Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.

    Measured: Within 2 weeks before the beginning of supplementation.

  4. Maximal dynamic strength of shoulder muscles post-supplementation

    Maximal dynamic strength of shoulder muscles will be assessed by measurement of one-repetition maximum.

    Measured: Within 2 weeks after the end of supplementation.

  5. Force-velocity relationship of knee flexors and extensors pre-supplementation

    Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.

    Measured: Within 2 weeks before the beginning of supplementation.

  6. Force-velocity relationship of knee flexors and extensors post-supplementation

    Force-velocity relationship of knee flexors and extensors will be assessed in isokinetic dynamometer.

    Measured: Within 2 weeks after the end of supplementation.

  7. 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.

    Measured: Within 4 days before the beginning of supplementation.

  8. 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.

    Measured: Within 4 days after the end of supplementation.

  9. Aerobic fitness pre-supplementation

    Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.

    Measured: Within 2 weeks before the beginning of supplementation.

  10. Aerobic fitness post-supplementation

    Aerobic fitness will be assessed by measurement of maximal oxygen uptake through a maximal graded exercise test on treadmill.

    Measured: Within 2 weeks after the end of supplementation.

  11. Muscle endurance pre-supplementation

    Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.

    Measured: Within 2 weeks before the beginning of supplementation.

  12. Muscle endurance post-supplementation

    Muscle endurance will be assessed by performing multiple sit-ups, knee flexions and knee extensions.

    Measured: Within 2 weeks after the end of supplementation.

Secondary outcomes (16)
  1. 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.

    Measured: Within 4 days before the beginning of supplementation.

  2. 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.

    Measured: Within 4 days after the end of supplementation.

  3. Hormonal analyses pre-supplementation

    Plasma cortisol and testosterone (both in μg/dL) will be measured by immunoluminescence in an automated analyzer.

    Measured: Within 4 days before the end of supplementation.

  4. Hormonal analyses post-supplementation

    Plasma cortisol and testosterone (both in μg/dL) will be measured by immunoluminescence in an automated analyzer.

    Measured: Within 4 days after the end of supplementation.

  5. Resting metabolic rate pre-supplementation

    Resting metabolic rate will be assessed with indirect calorimetry through the measurement of oxygen consumption with a metabolic analyzer.

    Measured: Within 2 weeks before the beginning of supplementation.

  6. Resting metabolic rate post-supplementation

    Resting metabolic rate will be assessed with indirect calorimetry through the measurement of oxygen consumption with a metabolic analyzer.

    Measured: Within 2 weeks after the end of supplementation.

  7. Internal load of exercise pre-supplementation

    Internal load of exercise will be assessed by telemetric heart rate sensors and software

    Measured: Within the first week of supplementation.

  8. Internal load of exercise post-supplementation

    Internal load of exercise will be assessed by telemetric heart rate sensors and software

    Measured: Within the last week of supplementation (week 6).

  9. Full blood count pre-supplementation

    Full blood count will be performed by flow cytometry

    Measured: Within 4 days before the beginning of supplementation

  10. Full blood count post-supplementation

    Full blood count will be performed by flow cytometry

    Measured: Within 4 days after the end of supplementation.

  11. Plasma enzymes pre-supplementation

    Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer

    Measured: Within 4 days before the beginning of supplementation.

  12. Plasma enzymes post-supplementation

    Creatine kinase and γ-glutamyltransferase (both in U/L) will be measured by chemiluminescence in an automated analyzer.

    Measured: Within 4 days after the end of supplementation.

  13. Force-velocity relationship of shoulder muscles pre-supplementation

    Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.

    Measured: Within 2 weeks before the beginning of supplementation.

  14. Force-velocity relationship of shoulder muscles post-supplementation

    Force-velocity relationship of shoulder muscles will be assessed by a linear encoder.

    Measured: Within 2 weeks after the end of supplementation.

  15. Maximal grip strength pre-supplementation

    Maximal grip strength will be assessed by a hand dynamometer

    Measured: Within 2 weeks before the beginning of supplementation

  16. Maximal grip strength post-supplementation

    Maximal grip strength will be assessed by a hand dynamometer

    Measured: Within 2 weeks after the end of supplementation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start1 Nov 2021
  3. Primary completion31 Mar 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05396963
Sponsor's protocol ID
EGGPROScience1
Status last verified
Oct 2023
First submitted
26 Apr 2022
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Egg white, Whey protein and Maltodextrin in people with Exercise Training and Dietary Supplements, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean and fat mass pre-supplementation (time frame: Within 2 weeks before the beginning of supplementation.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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