Skeletal Muscle EnergeticsNCT03811717
Fasting and Exercise-induced Changes in Human Skeletal Muscle
A study testing FAST+EX and FAST in people with Skeletal Muscle Energetics, run by Queen's University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Energetics
- What is being tested?
- FAST+EX and FAST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2019to 30 Apr 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- presence of cardiometabolic disease
- taking regular oral medication
- current smoker
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of Kinesiology and Health Studies
Kingston, Ontario, K7L3N6
About this study
Official title: 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.
- Conditions
- Skeletal Muscle Energetics
- Being tested
- FAST+EX, FAST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAST+EXOther
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.
FASTOther
Participants will complete an 8-hour fast.
| Study group | Role | What they receive |
|---|---|---|
| FAST+EX - FAST | Experimental | FAST+EX then FAST alone Receives: Other: FAST+EX; Other: FAST |
| FAST - FAST+EX | Experimental | FAST alone then FAST+EX Receives: Other: FAST+EX; Other: FAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroxisome proliferator activated receptor gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression
PGC-1α gene expression (indirect indicator of PGC-1α activity)
Measured: 15 min before fast; after 4 and 8 hours of fasting
Secondary outcomes (20)
Catecholamine concentrations
Epinephrine and norepinephrine concentrations in plasma samples
Measured: 15 min before fast; after exercise; after 4 and 8 hours of fasting
Glucose and insulin concentrations
Glucose and insulin concentrations in plasma samples
Measured: 15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated AMP activated protein kinase (AMPK)
active AMPK relative to total AMPK protein content
Measured: 15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated SIRT-1
active SIRT-1 relative to total SIRT1 protein content
Measured: 15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated mammalian target of rapamycin (mTOR)
active mTOR relative to total mTOR protein content
Measured: 15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated Akt/Protein Kinase B
active Akt relative to total Akt protein content
Measured: 15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated acetyl coenzyme A carboxylase (ACC)
active ACC relative to total ACC protein
Measured: 15 min before fast; after 4 and 8 hours of fasting
total and phosphorylated p38 mitogen activated protein kinase (MAPK)
active p38 MAPK relative to total p38 MAPK protein
Measured: 15 min before fast; after 4 and 8 hours of fasting
phosphorylated protein kinase A (PKA) substrates
phosphorylated PKA substrates (indirect measure of PKA activity)
Measured: 15 min before fast; after 4 and 8 hours of fasting
acetylated p53
p53 acetylation status (indirect measure of SIRT-1 deacetylase activity)
Measured: 15 min before fast; after 4 and 8 hours of fasting
Sirtuin 1 (SIRT1) mRNA expression
gene expression of the deacetylase enzyme SIRT1
Measured: 15 min before fast; after 4 and 8 hours of fasting
Sirtuin 3 (SIRT3) mRNA expression
gene expression of the deacetylase enzyme SIRT3
Measured: 15 min before fast; after 4 and 8 hours of fasting
Pyruvate dehydrogenase kinase isoenzyme 4 (PDK4) mRNA expression
gene expression of the PGC-1α target PDK4
Measured: 15 min before fast; after 4 and 8 hours of fasting
p53 mRNA expression
gene expression of the tumour suppressor protein p53
Measured: 15 min before fast; after 4 and 8 hours of fasting
Leucine rich pentatricopeptide repeat containing protein (LRP130) mRNA expression
gene expression of RNA-binding protein LRP130
Measured: 15 min before fast; after 4 and 8 hours of fasting
General control non-repressible 5 (GCN5) mRNA expression
gene expression of the acetyltransferase GCN5
Measured: 15 min before fast; after 4 and 8 hours of fasting
PGC-1α protein content
Protein content of the transcriptional co-activator PGC-1α
Measured: 15 min before fast; after 4 and 8 hours of fasting
Cytochrome C oxidase subunit 4 (COX-IV) protein content
Protein content of the mitochondrial enzyme COX subunit 4
Measured: 15 min before fast; after 4 and 8 hours of fasting
Intramuscular glycogen content
Muscle glycogen content
Measured: 15 min before fast; after 4 and 8 hours of fasting
Intramuscular triglyceride (IMTG) content
Muscle IMTG content
Measured: 15 min before fast; after 4 and 8 hours of fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start14 Jan 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle EnergeticsStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo
- Responsible party
- Principal investigator, Brendon Gurd, Queen's University
- Investigators
- Brendon J. Gurd, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811717
- Sponsor's protocol ID
- QMPL_HI-01-19
- Status last verified
- May 2019
- First submitted
- 17 Jan 2019
- Last updated
- 30 May 2019
- 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 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise-induced Energetic Stress During an 8-hour Fast on Metabolic Regulation in Resting Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT03811717
- Acronym / sponsor ID
- QMPL_HI-01-19
- Conditions
- Skeletal Muscle Energetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- University of Waterloo
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 22 Jan 2019 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST+EX - FAST | Experimental | Other: FAST+EX, Other: FASTFAST+EX then FAST alone |
| FAST - FAST+EX | Experimental | Other: FAST+EX, Other: FASTFAST alone then FAST+EX |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- presence of cardiometabolic disease
- taking regular oral medication
- current smoker
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 |
|---|---|---|
| FAST+EXParticipants 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 - FAST+EX, FAST+EX - FAST |
| FASTParticipants will complete an 8-hour fast. | Other | FAST - FAST+EX, FAST+EX - FAST |
Primary outcome
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)
20 secondary outcomes
Catecholamine concentrations
Time frame: 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
total and phosphorylated AMP activated protein kinase (AMPK)
Time frame: 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
total and phosphorylated mammalian target of rapamycin (mTOR)
Time frame: 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
total and phosphorylated acetyl coenzyme A carboxylase (ACC)
Time frame: 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
phosphorylated protein kinase A (PKA) substrates
Time frame: 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
Sirtuin 1 (SIRT1) mRNA expression
Time frame: 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
Pyruvate dehydrogenase kinase isoenzyme 4 (PDK4) mRNA expression
Time frame: 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
Leucine rich pentatricopeptide repeat containing protein (LRP130) mRNA expression
Time frame: 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
PGC-1α protein content
Time frame: 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
Intramuscular glycogen content
Time frame: 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
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 30 May 2019.
- 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.
Brendon J. Gurd, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAST+EX and FAST in people with Skeletal Muscle Energetics, run by Queen's University at 1 site in Canada.
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 3 inclusion and 3 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 30 May 2019. 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 Canada. 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. 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?
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). 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 30 May 2019.