NCT05396963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

April 26, 2022

Last Update Submit

October 3, 2023

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (16)

  • Biochemical analyses pre-supplementation

    Within 4 days before the beginning of supplementation.

  • Biochemical analyses post-supplementation

    Within 4 days after the end of supplementation.

  • Hormonal analyses pre-supplementation

    Within 4 days before the end of supplementation.

  • Hormonal analyses post-supplementation

    Within 4 days after the end of supplementation.

  • Resting metabolic rate pre-supplementation

    Within 2 weeks before the beginning of supplementation.

  • +11 more secondary outcomes

Study Arms (6)

Egg white - Whey protein - Maltodextrin

OTHER

Participants will receive egg white, whey protein, and maltodextrin in this order.

Dietary Supplement: Egg whiteDietary Supplement: Whey proteinDietary Supplement: Maltodextrin

Egg white - Maltodextrin - Whey protein

OTHER

Participants will receive egg white, maltodextrin, and whey protein in this order.

Dietary Supplement: Egg whiteDietary Supplement: Whey proteinDietary Supplement: Maltodextrin

Whey protein - Egg white - Maltodextrin

OTHER

Participants will receive whey protein, egg white, and maltodextrin in this order.

Dietary Supplement: Egg whiteDietary Supplement: Whey proteinDietary Supplement: Maltodextrin

Whey protein - Maltodextrin - Egg white

OTHER

Participants will receive whey protein, maltodextrin, and egg white in this order.

Dietary Supplement: Egg whiteDietary Supplement: Whey proteinDietary Supplement: Maltodextrin

Maltodextrin - Egg white - Whey protein

OTHER

Participants will receive maltodextrin, egg white, and whey protein in this order.

Dietary Supplement: Egg whiteDietary Supplement: Whey proteinDietary Supplement: Maltodextrin

Maltodextrin - Whey protein - Egg white

OTHER

Participants will receive maltodextrin, whey protein, and egg white in this order.

Dietary Supplement: Egg whiteDietary Supplement: Whey proteinDietary Supplement: Maltodextrin

Interventions

Egg whiteDIETARY_SUPPLEMENT

Intake of egg white

Egg white - Maltodextrin - Whey proteinEgg white - Whey protein - MaltodextrinMaltodextrin - Egg white - Whey proteinMaltodextrin - Whey protein - Egg whiteWhey protein - Egg white - MaltodextrinWhey protein - Maltodextrin - Egg white
Whey proteinDIETARY_SUPPLEMENT

Intake of whey protein

Egg white - Maltodextrin - Whey proteinEgg white - Whey protein - MaltodextrinMaltodextrin - Egg white - Whey proteinMaltodextrin - Whey protein - Egg whiteWhey protein - Egg white - MaltodextrinWhey protein - Maltodextrin - Egg white
MaltodextrinDIETARY_SUPPLEMENT

Intake of maltodextrin

Egg white - Maltodextrin - Whey proteinEgg white - Whey protein - MaltodextrinMaltodextrin - Egg white - Whey proteinMaltodextrin - Whey protein - Egg whiteWhey protein - Egg white - MaltodextrinWhey protein - Maltodextrin - Egg white

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Evaluation of Human Biological Performance

Thessaloniki, 57001, Greece

Location

MeSH Terms

Interventions

Egg WhiteWhey Proteinsmaltodextrin

Intervention Hierarchy (Ancestors)

EggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy Products

Study Officials

  • Vassilis Mougios

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

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, investigator, or outcome assessor.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 31, 2022

Study Start

November 1, 2021

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations