NCT02177604

Brief Summary

Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

June 19, 2014

Last Update Submit

May 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in glucose metabolism

    Changes in insulin and glucose area under the curve assessed via 75g Oral Glucose Tolerance Test.

    1 week

Secondary Outcomes (1)

  • Change in plasma levels of cytokines

    1 week

Other Outcomes (3)

  • Change in mitochondrial metabolism

    1 week

  • Change in resting energy expenditure

    1 week

  • Change in cognitive function

    1 week

Study Arms (3)

Wingate HIT

EXPERIMENTAL

7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training.

Other: Wingate HITOther: High-fat overfeeding

Modified HIT

EXPERIMENTAL

7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training

Other: Modified HITOther: High-fat overfeeding

No Exercise Control

ACTIVE COMPARATOR

7 days of high-fat overfeeding (50% excess calories) with no supervised exercise

Other: High-fat overfeeding

Interventions

3 sessions of Wingate based High-Intensity Interval Training (6-8 x 15 second "all out" sprints on a cycle ergometer interspersed by 2 minutes recovery)

Wingate HIT

3 sessions of Modified High-Intensity Interval Training (8 x 60 second sprints at approximately 90-95% VO2 peak on a cycle ergometer interspersed by 60 seconds recovery)

Modified HIT

7 days of high-fat overfeeding (50% excess calories)

Modified HITNo Exercise ControlWingate HIT

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)
  • Overweight (BMI 25-29.9 kg/m2)

You may not qualify if:

  • Personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.)
  • History of chest pain (either at rest or during exercise.)
  • Abnormal resting ECG at screening visit
  • Chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.)
  • Blood pressure or blood lipids outside of reference ranges
  • Serum ferritin \<30ng/mL
  • Uncontrolled asthma, current fever, or upper respiratory infection
  • Current intake of \> 140g alcohol/week
  • Current smokers of cigarettes/cigars/marijuana
  • Current intake of any illicit substance
  • Experience claustrophobia in confined spaces
  • Donated blood in the past 3 months
  • Migraines
  • Unable to comprehend study protocol
  • Unable to perform exercise on a cycle ergometer at second screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Australian Health & Medical Research Institute

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Leonie Heilbronn, PhD

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 27, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 25, 2018

Record last verified: 2018-05

Locations