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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03570424
Other study ID # 7867835
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2018
Est. completion date February 1, 2019

Study information

Verified date January 2020
Source University of Limerick
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- BMI >30 kg.m-2

- Metabolic disease (mitochondrial, Type 2 Diabetes)

Study Design


Intervention

Dietary Supplement:
Nutrient support to HIIT
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).
Placebo
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).

Locations

Country Name City State
Ireland University of Limerick Limerick Munster

Sponsors (1)

Lead Sponsor Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Organelle Biogenesis (Mitochondrial) Acute Acute phase - change in Peroxisome Proliferator Activated Receptor 1 alpha (PGC-1a) 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
Primary 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
Primary 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
Primary 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 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). Acute: 3 hours post HIIT session 1.
Secondary 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. Chronic - 72 hours post exercise session 9
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