NCT03570424

Brief Summary

High intensity interval training (HIIT) has recently emerged as a time efficient alternative to conventional endurance exercise, conferring similar or superior benefits in terms of metabolic and performance adaptations in both athletic and non-athletic populations. Some of these physiological adaptations include augmented mitochondrial biogenesis and improved substrate metabolism in peripheral tissues such as skeletal muscle. However, nutritional strategies to optimise the adaptations to HIIT have yet to be established. Recent evidence suggests that acute nutritional status can affect the molecular regulation of genes mediating substrate metabolism and mitochondrial biogenesis. Moreover, preliminary evidence suggests that completion of exercise in fasted conditions augments some of these exercise-induced adaptations compared with the fed state. Given the fact that the transient molecular adaptations to acute exercise mediate long-term physiological adaptations, an investigation into the effects of different nutritional interventions on metabolic and performance responses to HIIT is warranted. The purpose of this study is to determine the effects of fasted vs. fed-state (Whey Protein) HIIT on metabolic and performance adaptations in the acute (single exercise session) and chronic (3 weeks, 9 exercise sessions) phases. The primary hypothesis is that different pre-exercise feeding conditions (e.g. fasted placebo vs. Whey protein fed) will result in divergent physiological adaptations in terms of skeletal muscle metabolism and performance, both in response to a single HIIT session and a chronic HIIT intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

May 22, 2018

Last Update Submit

January 10, 2020

Conditions

Keywords

Organelle BiogenesisAdaptation, PhysiologicalWhey ProteinsProtein Hydrolysates

Outcome Measures

Primary Outcomes (4)

  • Organelle Biogenesis (Mitochondrial) Acute

    Acute phase - change in Peroxisome Proliferator Activated Receptor 1 alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression in response to a single HIIT session. Measured using real-time polymerase chain reaction (RT-PCR).

    Acute - 3 hours post exercise session 1

  • Exercise Performance

    Mean power output (Watts) during 20 minute cycling performance test. Measured using cycle ergometer and associated software.

    Chronic - 72 hours post exercise session 9

  • Anaerobic Exercise Performance

    Anaerobic exercise performance peak power (Watts). Measured using 30 second Wingate test on a Monark 894E cycle ergometer.

    Chronic - 72 hours post exercise session 9

  • Organelle Biogenesis (Mitochondrial) Chronic

    Chronic Phase - change in Citrate Synthase Activity measured using commercially available assay kits.

    Chronic - 48 hours post exercise session 9

Secondary Outcomes (2)

  • Organelle Biogenesis (Mitochondrial)

    Acute: 3 hours post HIIT session 1.

  • Cycling Economy

    Chronic - 72 hours post exercise session 9

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Intervention (Nutrient support to HIIT): Participants consume 0.33g.kg-1 body mass of artificially flavoured and textured placebo 45 minutes prior to HIIT exercise

Dietary Supplement: Placebo

Whey Protein

EXPERIMENTAL

Intervention (Nutrient support to HIIT): Participants consume 0.33g.kg-1 body mass intact whey protein 45 minutes prior to HIIT exercise

Dietary Supplement: Nutrient support to HIIT

Whey Protein Hydrolysate

EXPERIMENTAL

Intervention (Nutrient support to HIIT): Participants consume 0.33g.kg-1 body mass hydrolysed whey protein 45 minutes prior to HIIT exercise

Dietary Supplement: Nutrient support to HIIT

Interventions

Nutrient support to HIITDIETARY_SUPPLEMENT

3 groups of young (aged 18-35 y), healthy, recreationally active, aerobically untrained (VO2max \<50 ml.kg.min-1) males will undertake 3 weeks (9 sessions) of HIIT under different nutrient conditions following \>10h overnight fast: i) Placebo: Fasted artificially flavoured and textured placebo 45 minutes prior to exercise; ii) Whey protein 45 minutes prior to exercise; iii) Whey protein hydrolysate 45 minutes prior to exercise).

Whey ProteinWhey Protein Hydrolysate
PlaceboDIETARY_SUPPLEMENT

3 groups of young (aged 18-35 y), healthy, recreationally active, aerobically untrained (VO2max \<50 ml.kg.min-1) males will undertake 3 weeks (9 sessions) of HIIT under different nutrient conditions following \>10h overnight fast: i) Fasted artificially flavoured and textured placebo 45 minutes prior to exercise; ii) Fed Whey protein 45 minutes prior to exercise; iii) Fed Whey protein hydrolysate 45 minutes prior to exercise).

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (absence of clinical condition)
  • Recreationally active
  • Aerobically untrained (VO2max \<50 ml.kg.min-1)
  • Protein sufficient (\>0.8 g.kg.d-1)
  • Males
  • Able to provide informed consent
  • No contraindications to high intensity exercise

You may not qualify if:

  • BMI \>30 kg.m-2
  • Metabolic disease (mitochondrial, Type 2 Diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Limerick

Limerick, Munster, V94 T9PX, Ireland

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Brian P Carson, PhD

    University of Limerick

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are block randomised to one of three nutrient conditions on provision of informed consent. This information is held by the PI and members of the research team independent of the outcomes assessor (masked). All three beverages are made up by members of the research team independent of the outcomes assessor (masked) and the participants (masked). Each participant (masked) is provided with a drink in a black, non-transparent, container with no details of its contents other than that is a "nutrient supplement".
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomly assigned, parallel group, simple pre-post design has been adopted to answer this question. 3 groups of young (aged 18-35 y), healthy, recreationally active, aerobically untrained (VO2max \<50 ml.kg.min-1) males will undertake 3 weeks (9 sessions) of HIIT under different nutrient conditions following \>10h overnight fast: i) Fasted placebo (0.33g.kg-1 body artificially flavoured and textured placebo); ii) Fed Whey protein (0.33g.kg-1 body mass intact whey protein 45 minutes prior to exercise); iii) Fed Whey protein hydrolysate (0.33g.kg-1 body mass hydrolysed whey protein 45 minutes prior to exercise). Participants will undergo biological sampling (venous blood and muscle biopsy) and measures of performance pre and post the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Exercise Physiology, University of Limerick

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 27, 2018

Study Start

January 31, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations