Muscle, SkeletalNCT03570424
Whey Protein Support to Metabolic and Performance Adaptations in Response HIIT
A study testing Nutrient support to HIIT in people with Muscle, Skeletal and High-Intensity Interval Training, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle, Skeletal, High-Intensity Interval Training, Exercise
- What is being tested?
- Nutrient support to HIIT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIreland
- Study dates
- 31 Jan 2018to 1 Feb 2019
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- BMI >30 kg.m-2
- Metabolic disease (mitochondrial, Type 2 Diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whey Protein Support to Metabolic and Performance Adaptations in Response to High Intensity Interval Training in Young Adult Men
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.
Read the detailed description
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 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.
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), protein sufficient (>0.8 g.kg.d-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 mass 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.
- Conditions
- Muscle, Skeletal, High-Intensity Interval Training, Exercise
- Being tested
- Nutrient support to HIIT, Placebo
- Keywords
- Organelle Biogenesis, Adaptation, Physiological, Whey Proteins, Protein Hydrolysates
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Nutrient support to HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Chronic - 72 hours post exercise session 9
Organelle Biogenesis (Mitochondrial) Chronic
Chronic Phase - change in Citrate Synthase Activity measured using commercially available assay kits.
Measured: Chronic - 48 hours post exercise session 9
Secondary outcomes (2)
Organelle Biogenesis (Mitochondrial)
Pyruvate Dehydrogenase Kinase 4 (PDK4), Peroxisome Proliferator Activated Receptor (PPAR) delta, Sirtuin 1 (SIRT1) mRNA expression. Measured using real-time polymerase chain reaction (RT-PCR).
Measured: Acute: 3 hours post HIIT session 1.
Cycling Economy
Cycling economy (W.VO2 L.min-1) during multiple incremental stages (50 W, 100 W, 150 W, 200 W, 250 W) of a submaximal cycling test.
Measured: Chronic - 72 hours post exercise session 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start31 Jan 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle, SkeletalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Carson, University of Limerick
- Investigators
- Brian P Carson, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570424
- Sponsor's protocol ID
- 7867835
- Status last verified
- Jan 2020
- First submitted
- 22 May 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey Protein Support to Metabolic and Performance Adaptations in Response to High Intensity Interval Training in Young Adult Men
- ClinicalTrials.gov ID
- NCT03570424
- Acronym / sponsor ID
- 7867835
- Conditions
- Muscle, Skeletal, High-Intensity Interval Training, Exercise
- Keywords
- Organelle Biogenesis, Adaptation, Physiological, Whey Proteins, Protein Hydrolysates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
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), protein sufficient (>0.8 g.kg.d-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 mass 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIntervention (Nutrient support to HIIT): Participants consume 0.33g.kg-1 body mass of artificially flavoured and textured placebo 45 minutes prior to HIIT exercise |
| Whey Protein | Experimental | Dietary Supplement: Nutrient support to HIITIntervention (Nutrient support to HIIT): Participants consume 0.33g.kg-1 body mass intact whey protein 45 minutes prior to HIIT exercise |
| Whey Protein Hydrolysate | Experimental | Dietary Supplement: Nutrient support to HIITIntervention (Nutrient support to HIIT): Participants consume 0.33g.kg-1 body mass hydrolysed whey protein 45 minutes prior to HIIT exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy (absence of clinical condition)
- Recreationally active
- Aerobically untrained (VO2max <50 ml.kg.min-1)
- Protein sufficient (>0.8 g.kg.d-1)
- Males
Key exclusion criteria (2 listed)
- BMI >30 kg.m-2
- Metabolic disease (mitochondrial, Type 2 Diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrient support to HIIT3 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). | Dietary supplement | Whey Protein, Whey Protein Hydrolysate |
| Placebo3 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). | Dietary supplement | Placebo |
Primary outcome
Organelle Biogenesis (Mitochondrial) Acute
Time frame: Acute - 3 hours post exercise session 1
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).
Exercise Performance
Time frame: Chronic - 72 hours post exercise session 9
Mean power output (Watts) during 20 minute cycling performance test. Measured using cycle ergometer and associated software.
Anaerobic Exercise Performance
Time frame: Chronic - 72 hours post exercise session 9
Anaerobic exercise performance peak power (Watts). Measured using 30 second Wingate test on a Monark 894E cycle ergometer.
Organelle Biogenesis (Mitochondrial) Chronic
Time frame: Chronic - 48 hours post exercise session 9
Chronic Phase - change in Citrate Synthase Activity measured using commercially available assay kits.
2 secondary outcomes
Organelle Biogenesis (Mitochondrial)
Time frame: Acute: 3 hours post HIIT session 1.
Cycling Economy
Time frame: Chronic - 72 hours post exercise session 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P Carson, PhD principal investigator
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrient support to HIIT in people with Muscle, Skeletal and High-Intensity Interval Training, run by University of Limerick at 1 site in Ireland.
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 7 inclusion and 2 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 13 Jan 2020. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Organelle Biogenesis (Mitochondrial) Acute (time frame: Acute - 3 hours post exercise session 1). The study lists 4 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 13 Jan 2020.