NCT02370212

Brief Summary

Recent evidence suggests that high -intensity interval training (HIIT) may be an effective strategy to improve cardiorespiratory fitness, exercise performance, and insulin sensitivity. In addition, creatine (Cr), a nitrogen- containing compound, is widely used to enhance high intensity exercise performance. A seminal study demonstrated that the muscle content of Cr and phosphocreatine (PCr) can be elevated by exogenous Cr. Oral intake of Cr increases the concentration in blood and muscle, and part of the increased muscle Cr is transformed to PCr (a process catalyzed by Cr kinase). Cr supplementation increases total Cr (TCr = Cr + PCr) by \~20%, with the PCr component accounting for 10% of the increase. Combining HIIT and Cr is intriguing for two reasons; first, Cr supplementation improves performance through increasing PCr, PCr recovery, and muscle buffering which may facilitate higher training intensities and therefore greater training adaptations. Secondly, both Cr and HIIT have individually been shown to increase GLUT 4 and insulin sensitivity, suggesting that Cr supplementation may be an adjunct to HIIT for improving glucose control. To date, there have only been two studies investigating the performance effects of Cr combined with HIIT with preliminary positive results. No studies have examined the impact of combined Cr + HIIT on outcomes related to insulin sensitivity. Therefore, the purpose of this research is to examine the combined effects of Cr and HIIT on performance and insulin sensitivity as determined via an oral glucose tolerance test (OGTT) in young healthy adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

February 4, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

February 4, 2015

Last Update Submit

January 15, 2016

Conditions

Keywords

Creatineinterval trainingeffects on performance

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in exercise performance at 4 weeks

    Assessed by a 50 kilojoule (kJ) time trial test

    4 weeks

Secondary Outcomes (3)

  • Change from Baseline in cardiorespiratory fitness

    4 weeks

  • Change from Baseline in body composition

    4 weeks

  • Change from Baseline in insulin sensitivity

    4 weeks

Study Arms (2)

Creatine

EXPERIMENTAL

Creatine will be ingested after interval training and at supper time on training days and in the morning and afternoon on non-training days (0.05 g/kg body mass of creatine with 0.05 g/kg flavoured dextrose per dose). Both experimental and placebo groups will perform the same high intensity interval training protocols (3x/week for 4 weeks).

Dietary Supplement: CreatineOther: High intensity interval training

Placebo

PLACEBO COMPARATOR

The placebo will be ingested after interval training and at supper time on training days and in the morning and afternoon on non-training days (0.1 g/kg flavoured dextrose per dose, isocaloric to the creatine). Both experimental and placebo groups will perform the same high intensity interval training protocols (3x/week for 4 weeks).

Dietary Supplement: PlaceboOther: High intensity interval training

Interventions

CreatineDIETARY_SUPPLEMENT
Creatine
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

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

You may qualify if:

  • Between 18--35 years of age
  • Can read, comprehend, and speak English
  • Free of diagnosed metabolic disease (e.g., prediabetes, diabetes)
  • Willing and able to perform high-intensity exercise training
  • Willing and able to consume creatine or placebo supplements over the study period

You may not qualify if:

  • Diagnosed metabolic disorder such as diabetes, metabolic syndrome, prediabetes, hypothyroidism, cardiovascular disease or any other condition known to affect metabolism
  • Currently engaged in high-intensity interval training \>2 time per week
  • Currently taking creatine or other supplements or having taken creatine in the last 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CreatineHigh-Intensity Interval Training

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 24, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01