NCT03811717

Brief 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. Changes in metabolic pathways will be examined in resting (leg) muscle before, during, and after the fast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 14, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

January 17, 2019

Last Update Submit

May 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 min before fast; after 4 and 8 hours of fasting

Secondary Outcomes (20)

  • Catecholamine concentrations

    15 min before fast; after exercise; after 4 and 8 hours of fasting

  • Glucose and insulin concentrations

    15 min before fast; after 4 and 8 hours of fasting

  • total and phosphorylated AMP activated protein kinase (AMPK)

    15 min before fast; after 4 and 8 hours of fasting

  • total and phosphorylated SIRT-1

    15 min before fast; after 4 and 8 hours of fasting

  • total and phosphorylated mammalian target of rapamycin (mTOR)

    15 min before fast; after 4 and 8 hours of fasting

  • +15 more secondary outcomes

Study Arms (2)

FAST+EX - FAST

EXPERIMENTAL

FAST+EX then FAST alone

Other: FAST+EXOther: FAST

FAST - FAST+EX

EXPERIMENTAL

FAST alone then FAST+EX

Other: FAST+EXOther: FAST

Interventions

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.

FAST - FAST+EXFAST+EX - FAST
FASTOTHER

Participants will complete an 8-hour fast.

FAST - FAST+EXFAST+EX - FAST

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Kinesiology and Health Studies

Kingston, Ontario, K7L3N6, Canada

Location

Study Officials

  • Brendon J. Gurd, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation concealment, assessor blinding
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 22, 2019

Study Start

January 14, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations