NCT02397304

Brief Summary

Obesity is a major public health issue and its association with insulin resistance greatly increases risks for cardiovascular disease and type 2 diabetes. Exercise training is recommended for obese populations, but longitudinal studies indicate aerobic exercise training in obese individuals in the absence of weight loss has minimal impact on insulin resistance. High turnover of fat stored within muscle cells (i.e., intramyocellular triglyceride) during exercise and elevated muscle fitness (i.e., muscle oxidative capacity) are key features of the enhanced insulin sensitivity observed in endurance-trained individuals. It could be that longitudinal studies of exercise training in obese individuals failed to sufficiently stimulate intramyocellular triglyceride turnover during exercise and muscle oxidative adaptation as a result of failure to consider the impact of recent nutrition within their study designs. Performing exercise in the fed vs. fasted state can blunt these exercise responses in non-obese individuals. The researchers will investigate the hypothesis that an acute bout of aerobic exercise performed in the overnight-fasted versus fed-state can stimulate greater intramyocellular triglyceride utilization during exercise and enhanced expression of genes related to muscle oxidative adaptation in obese individuals. The expected outcomes will help to determine if exercising in the fasted state could be used to optimise metabolic adaptation to training in obese individuals. The future impact of this research could be the recommendation of a simple nutritional strategy considering meal timing to enhance the effects of aerobic exercise training in obese individuals, with potential long-term benefits for reducing insulin resistance and cardio-metabolic disease risk.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable obesity

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 12, 2015

Last Update Submit

March 18, 2015

Conditions

Keywords

Intra-muscular triglyceride use

Outcome Measures

Primary Outcomes (1)

  • Intramuscular triglyceride use during exercise (arbitrary units)

    Does exercising in the overnight-fasted state promote greater breakdown of intramuscular fat than performing exercise in the fed state?

    Up to 12 months

Secondary Outcomes (1)

  • Gene expression

    Up to 12 months

Study Arms (2)

Pre-exercise food

EXPERIMENTAL

Pre-exercise food provision

Other: Exercise

Post-exercise food

EXPERIMENTAL

Post-exercise food provision

Other: Exercise

Interventions

Participants will complete two morning exercise sessions. One will be performed in the overnight fasted-state (i.e. no food or drink, except water, from 10pm the evening before) and the other will be performed in the fed-state having received a breakfast by the research team before exercise.

Post-exercise foodPre-exercise food

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Answering "YES" to any question on the Screening Form
  • Hypertension (≥140/90 mmHg)
  • Any ECG Abnormalities
  • Current participation in another clinical study
  • Current or recent smoker (last 30 days)
  • Past history of substance abuse, engagement in uncommon eating practices (e.g., sustained periods of fasting) and taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.
  • Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Edinburgh RM, Bradley HE, Abdullah NF, Robinson SL, Chrzanowski-Smith OJ, Walhin JP, Joanisse S, Manolopoulos KN, Philp A, Hengist A, Chabowski A, Brodsky FM, Koumanov F, Betts JA, Thompson D, Wallis GA, Gonzalez JT. Lipid Metabolism Links Nutrient-Exercise Timing to Insulin Sensitivity in Men Classified as Overweight or Obese. J Clin Endocrinol Metab. 2020 Mar 1;105(3):660-76. doi: 10.1210/clinem/dgz104.

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gareth A Wallis, PhD

CONTACT

Scott L Robinson, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 24, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 24, 2015

Record last verified: 2015-03