- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811717
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- 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
-
-
Ontario
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: FAST+EX - FAST
FAST+EX then FAST alone
|
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.
Participants will complete an 8-hour fast.
|
|
Experimental: FAST - FAST+EX
FAST alone then 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.
Participants will complete an 8-hour fast.
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
January 14, 2019
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
January 17, 2019
First Submitted That Met QC Criteria
January 17, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Actual)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID 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.