Clinical trial NCT05396963: Egg White Supplementation in High-Intensity Functional Training
Official title: Effects of Egg White Supplementation on Body Composition, Physical Performance, and Amino Acid Profile of Individuals Undergoing High-intensity Functional Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Training
Dietary Supplements
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: European Commission
name: Greek Ministry of Development
First posted: 2022-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Lean and fat mass pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Lean and fat mass post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
measure: Maximal dynamic strength of shoulder muscles pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Maximal dynamic strength of shoulder muscles post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
measure: Force-velocity relationship of knee flexors and extensors pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Force-velocity relationship of knee flexors and extensors post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
measure: Plasma amino acid profile pre-supplementation
timeFrame: Within 4 days before the beginning of supplementation.
measure: Plasma amino acid profile post-supplementation
timeFrame: Within 4 days after the end of supplementation.
measure: Aerobic fitness pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Aerobic fitness post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
measure: Muscle endurance pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Muscle endurance post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
Secondary outcomes:
measure: Biochemical analyses pre-supplementation
timeFrame: Within 4 days before the beginning of supplementation.
measure: Biochemical analyses post-supplementation
timeFrame: Within 4 days after the end of supplementation.
measure: Hormonal analyses pre-supplementation
timeFrame: Within 4 days before the end of supplementation.
measure: Hormonal analyses post-supplementation
timeFrame: Within 4 days after the end of supplementation.
measure: Resting metabolic rate pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Resting metabolic rate post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
measure: Internal load of exercise pre-supplementation
timeFrame: Within the first week of supplementation.
measure: Internal load of exercise post-supplementation
timeFrame: Within the last week of supplementation (week 6).
measure: Full blood count pre-supplementation
timeFrame: Within 4 days before the beginning of supplementation
measure: Full blood count post-supplementation
timeFrame: Within 4 days after the end of supplementation.
measure: Plasma enzymes pre-supplementation
timeFrame: Within 4 days before the beginning of supplementation.
measure: Plasma enzymes post-supplementation
timeFrame: Within 4 days after the end of supplementation.
measure: Force-velocity relationship of shoulder muscles pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation.
measure: Force-velocity relationship of shoulder muscles post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
measure: Maximal grip strength pre-supplementation
timeFrame: Within 2 weeks before the beginning of supplementation
measure: Maximal grip strength post-supplementation
timeFrame: Within 2 weeks after the end of supplementation.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Evaluation of Human Biological Performance
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Vassilis Mougios
role: PRINCIPAL_INVESTIGATOR
References: