Fasting and Exercise-induced Changes in Human Skeletal Muscle

May 29, 2019 updated by: Brendon Gurd, Queen's University

Impact of Exercise-induced Energetic Stress During an 8-hour Fast on Metabolic Regulation in Resting Human Skeletal Muscle

This study examines the impact of increasing energetic stress during an 8-hour fast on metabolic pathways in human skeletal muscle. Specifically, participants will undergo two 8-hour fasting sessions in a randomized crossover fashion, with the addition of low-intensity arm exercise in one of the sessions. Changes in metabolic pathways will be examined in resting (leg) muscle before, during, and after the fast.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L3N6
        • School of Kinesiology and Health Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • recreationally active (no more than 3 hours of weekly physical activity)
  • not currently involved in a systematic training program
  • body mass index < 30 kg/m2

Exclusion Criteria:

  • presence of cardiometabolic disease
  • taking regular oral medication
  • current smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FAST+EX - FAST
FAST+EX then FAST alone
Other: FAST+EX
Participants will perform 2-hours of low-intensity arm exercise (8 x 15 min bouts of arm ergometer exercise separated by 10 min of rest) during an 8-hour fast.
Other: FAST
Participants will complete an 8-hour fast.
Experimental: FAST - FAST+EX
FAST alone then FAST+EX
Other: FAST+EX
Participants will perform 2-hours of low-intensity arm exercise (8 x 15 min bouts of arm ergometer exercise separated by 10 min of rest) during an 8-hour fast.
Other: FAST
Participants will complete an 8-hour fast.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peroxisome proliferator activated receptor gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
PGC-1α gene expression (indirect indicator of PGC-1α activity)
15 min before fast; after 4 and 8 hours of fasting

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Catecholamine concentrations
Time Frame: 15 min before fast; after exercise; after 4 and 8 hours of fasting
Epinephrine and norepinephrine concentrations in plasma samples
15 min before fast; after exercise; after 4 and 8 hours of fasting
Glucose and insulin concentrations
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
Glucose and insulin concentrations in plasma samples
15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated AMP activated protein kinase (AMPK)
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
active AMPK relative to total AMPK protein content
15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated SIRT-1
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
active SIRT-1 relative to total SIRT1 protein content
15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated mammalian target of rapamycin (mTOR)
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
active mTOR relative to total mTOR protein content
15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated Akt/Protein Kinase B
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
active Akt relative to total Akt protein content
15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated acetyl coenzyme A carboxylase (ACC)
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
active ACC relative to total ACC protein
15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated p38 mitogen activated protein kinase (MAPK)
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
active p38 MAPK relative to total p38 MAPK protein
15 min before fast; after 4 and 8 hours of fasting
phosphorylated protein kinase A (PKA) substrates
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
phosphorylated PKA substrates (indirect measure of PKA activity)
15 min before fast; after 4 and 8 hours of fasting
acetylated p53
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
p53 acetylation status (indirect measure of SIRT-1 deacetylase activity)
15 min before fast; after 4 and 8 hours of fasting
Sirtuin 1 (SIRT1) mRNA expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
gene expression of the deacetylase enzyme SIRT1
15 min before fast; after 4 and 8 hours of fasting
Sirtuin 3 (SIRT3) mRNA expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
gene expression of the deacetylase enzyme SIRT3
15 min before fast; after 4 and 8 hours of fasting
Pyruvate dehydrogenase kinase isoenzyme 4 (PDK4) mRNA expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
gene expression of the PGC-1α target PDK4
15 min before fast; after 4 and 8 hours of fasting
p53 mRNA expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
gene expression of the tumour suppressor protein p53
15 min before fast; after 4 and 8 hours of fasting
Leucine rich pentatricopeptide repeat containing protein (LRP130) mRNA expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
gene expression of RNA-binding protein LRP130
15 min before fast; after 4 and 8 hours of fasting
General control non-repressible 5 (GCN5) mRNA expression
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
gene expression of the acetyltransferase GCN5
15 min before fast; after 4 and 8 hours of fasting
PGC-1α protein content
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
Protein content of the transcriptional co-activator PGC-1α
15 min before fast; after 4 and 8 hours of fasting
Cytochrome C oxidase subunit 4 (COX-IV) protein content
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
Protein content of the mitochondrial enzyme COX subunit 4
15 min before fast; after 4 and 8 hours of fasting
Intramuscular glycogen content
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
Muscle glycogen content
15 min before fast; after 4 and 8 hours of fasting
Intramuscular triglyceride (IMTG) content
Time Frame: 15 min before fast; after 4 and 8 hours of fasting
Muscle IMTG content
15 min before fast; after 4 and 8 hours of fasting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen's University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Waterloo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brendon J. Gurd, PhD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QMPL_HI-01-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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