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Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding? (GAINHIT)

Primary Purpose

Insulin Resistance

Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Wingate HIT
Modified HIT
High-fat overfeeding
Sponsored by
University of Adelaide
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • South Australian Health & Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Wingate HIT

Modified HIT

No Exercise Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in plasma levels of cytokines
Change in plasma levels of adiponectin, irisin, sex hormone-binding globulin and c-reactive protein

Full Information

First Posted
June 19, 2014
Last Updated
May 23, 2018
Sponsor
University of Adelaide
Collaborators
Royal Adelaide Hospital, University of South Australia
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1. Study Identification

Unique Protocol Identification Number
NCT02177604
Brief Title
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Acronym
GAINHIT
Official Title
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide
Collaborators
Royal Adelaide Hospital, University of South Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wingate HIT
Arm Type
Experimental
Arm Description
7 days of high-fat overfeeding (50% excess calories) in conjunction 3 supervised sessions of Wingate High-intensity Interval Training.
Arm Title
Modified HIT
Arm Type
Experimental
Arm Description
7 days of high-fat overfeeding (50% excess calories) in conjunction with 3 supervised sessions of Modified High-Intensity Interval Training
Arm Title
No Exercise Control
Arm Type
Active Comparator
Arm Description
7 days of high-fat overfeeding (50% excess calories) with no supervised exercise
Intervention Type
Other
Intervention Name(s)
Wingate HIT
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Modified HIT
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
High-fat overfeeding
Intervention Description
7 days of high-fat overfeeding (50% excess calories)
Primary Outcome Measure Information:
Title
Change in glucose metabolism
Description
Changes in insulin and glucose area under the curve assessed via 75g Oral Glucose Tolerance Test.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in plasma levels of cytokines
Description
Change in plasma levels of adiponectin, irisin, sex hormone-binding globulin and c-reactive protein
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Change in mitochondrial metabolism
Description
Changes in citrate synthase activity, mitochondrial DNA content and protein levels of PGC-1a
Time Frame
1 week
Title
Change in resting energy expenditure
Description
Changes in resting energy expenditure measured by metabolic cart
Time Frame
1 week
Title
Change in cognitive function
Description
Changes in cognitive function, assessed by a series of computer tasks involving vigilant attention and speed processing.
Time Frame
1 week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week) Overweight (BMI 25-29.9 kg/m2) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie Heilbronn, PhD
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Australian Health & Medical Research Institute
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia

12. IPD Sharing Statement

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Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?

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