NCT02870075

Brief Summary

The purpose of this study is to investigate whether dietary conditions (fed versus fasted) affects the acute responses to exercise.

Trial Health

100
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 May 2013

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

February 9, 2016

Last Update Submit

August 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in gene expression in the adipose tissue

    Before the meal and 1 h after exercise (255 minutes)

Secondary Outcomes (3)

  • Changes in insulin, glucose, TAG and NEFA in blood

    255 minutes

  • Changes in serum Interleukin-6 (IL-6), leptin and adiponectin

    255 minutes

  • Changes in Interleukin-6 (IL-6), leptin and adiponectin protein secretion from adipose tissue explants

    Before the meal and 1 h after exercise (255 minutes)

Study Arms (2)

Fed exercise

ACTIVE COMPARATOR

Fed prior to exercise

Behavioral: Fed exercise

Fasted exercise

ACTIVE COMPARATOR

Fasted prior to exercise

Behavioral: Fasted exercise

Interventions

Fed exerciseBEHAVIORAL

Participants consumed a meal (Fed) 2 h prior to 1 h moderate intensity exercise at 60% VO2max.

Fed exercise
Fasted exerciseBEHAVIORAL

Participants remained fasting (Fasted) 2 h prior to 1 h moderate intensity exercise at 60% VO2max.

Fasted exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Aged between 18 to 35 years
  • Central overweight (waist circumference 94-128 cm)
  • Weight stable for more than 3 months (no change in weight +/- 3%)
  • Non-smoker
  • Able to walk for a long period of time

You may not qualify if:

  • Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
  • Waist circumference \< 94cm and \>128cm
  • Taking medications that may influence lipid or carbohydrate metabolism or immune system function
  • Unable to take part in structured exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen YC, Travers RL, Walhin JP, Gonzalez JT, Koumanov F, Betts JA, Thompson D. Feeding influences adipose tissue responses to exercise in overweight men. Am J Physiol Endocrinol Metab. 2017 Jul 1;313(1):E84-E93. doi: 10.1152/ajpendo.00006.2017. Epub 2017 Mar 14.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 9, 2016

First Posted

August 17, 2016

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

January 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08