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Training in the Fasted State, Glucose Metabolism and Energy Balance

Primary Purpose

Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Breakfast
Maintain habitual habits
Sponsored by
University of Bath
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders focused on measuring Exercise, Fasted, Glucose, Energy Balance

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male
  • Aged 18-49
  • Body mass index (BMI) > 25 kg/m2
  • Weight stable for > 6 months
  • Not currently engaging in any form of structured exercise
  • Be able and willing to give informed oral and written consent
  • Complete and meet the defined criteria of pre-study questionnaires and screen

Exclusion Criteria:

  • Have a history of metabolic, cardio-pulmonary or musculoskeletal disease
  • Have plans to change diet and/or physical activity outside of the intervention
  • Taking regular medication or food supplements from which it is not possible to refrain and which are known to influence any of the outcome measures.
  • Failure to refrain from alcohol and/or caffeine containing drinks or strenuous exercise one day before or during the trial days
  • Smokers
  • Any reported condition or behavior deemed to pose a risk to the participant or introduce bias into the experiment

Sites / Locations

  • Department for Health, University of Bath

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Control Group

Fed Exercise

Fasted Exercise

Arm Description

Maintain habitual habits

6 weeks of moderate intensity exercise with breakfast consumption

6 weeks of moderate intensity exercise with breakfast omission

Outcomes

Primary Outcome Measures

Postprandial plasma glucose concentrations
Response to oral glucose tolerance test (area under the curve)
Postprandial insulin concentrations
Response to oral glucose tolerance test (area under the curve)

Secondary Outcome Measures

Oral Glucose Insulin Sensitivity Index
Response to oral glucose tolerance test
Cardiorespiratory fitness (VO2max)
Habitual energy intake
Assessed via a food diary, completed at baseline and during the last week of the intervention
Habitual energy expenditure
Assessed via an Actiheart monitor, completed at baseline and during the last week of the intervention
Body mass (kg)
Waist and hip circumference (cm)
Maximal rate of whole-body lipid oxidation (g/min)
During an incremental exercise test
Fasting plasma glucose concentration
Fasting plasma glucose concentration (mmol/L)
Fasting plasma insulin concentration
Fasting plasma insulin concentration (pmol/L)
Postprandial non-esterified fatty acid concentrations
Response to oral glucose tolerance test (total and incremental area under the curve)
Fasting plasma triglyceride concentrations
Fasting plasma triglyceride concentrations (mmol/L)
Fasting plasma total cholesterol concentrations
Fasting plasma total cholesterol concentrations (mmol/L)
Fasting plasma HDL cholesterol concentrations
Fasting plasma HDL cholesterol concentrations (mmol/L)
Fasting plasma LDL cholesterol concentrations
Fasting plasma LDL cholesterol concentrations (mmol/L)
Fasting plasma non-esterified fatty acid concentrations
Fasting plasma non-esterified fatty acid concentrations (mmol/L)
Waist to hip ratio
Waist circumference (cm) divided by hip circumference (cm)
Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner)
Skeletal muscle (vastus lateralis). Citrate Synthase Activity Assay Kit.
Protein content of mitochondrial respiratory chain proteins
Skeletal muscle (vastus lateralis). Complex I, Complex II, Complex III, Complex IV.
Protein content of carnitine palmitoyltransferase I (CPT-1)
Skeletal muscle (vastus lateralis)
Protein content of cluster of differentiation 36 (CD36)
Skeletal muscle (vastus lateralis)
Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK)
Skeletal muscle (vastus lateralis)
Resting metabolic rate (RMR)
Assessed via indirect calirometry
Energy balance
Total energy expenditure minus total energy intake
Whole-body lipid utilisation during exercise
Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Whole-body carbohydrate utilisation during exercise
Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Homeostasis Model Assessment (HOMA2-IR)
The Homeostasis Model Assessment (HOMA) estimate of steady state beta cell function (%B) and insulin sensitivity (%S). Derived from fasting plasma glucose and fasting plasma insulin concentrations.
Fasting plasma glycerol concentrations
Fasting plasma glycerol concentrations (mmol/L)
Postprandial plasma glycerol concentrations
Response to oral glucose tolerance test (total and incremental area under the curve)
Adipose Tissue Insulin Resistance Index (Adipo-IR)
Response to oral glucose tolerance test (total and incremental area under the curve)

Full Information

First Posted
April 11, 2016
Last Updated
November 23, 2022
Sponsor
University of Bath
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1. Study Identification

Unique Protocol Identification Number
NCT02744183
Brief Title
Training in the Fasted State, Glucose Metabolism and Energy Balance
Official Title
Training in the Fasted State, Glucose Metabolism and Energy Balance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bath

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In healthy individuals, the body responds to glucose (sugar) ingestion by reducing the amount released from the liver. At the same time, skeletal muscles increase the rate at which they remove the glucose from the bloodstream, via the actions of the hormone insulin. This ensures that blood glucose levels remain in a controlled range. However, in developed countries, diseases such as metabolic syndrome and type 2 diabetes are becoming prevalent, due to dietary modifications and a reduction in physical activity. As one of the prominent barriers to regular physical activity is a lack of time, finding ways to maximize the health benefits of exercise is a priority for researchers. The investigators want to understand potential differences in the effects of six weeks of aerobic training, with the exercise performed either after breakfast or after a prolonged fast. Specifically, this research aims to investigate whether there is a difference in the change in processes implicated in glucose regulation and secondly, in subsequent eating and physical activity behaviors. By investigating these changes this work will explore how exercise and nutrition can be optimized to benefit health and weight loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders
Keywords
Exercise, Fasted, Glucose, Energy Balance

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Maintain habitual habits
Arm Title
Fed Exercise
Arm Type
Active Comparator
Arm Description
6 weeks of moderate intensity exercise with breakfast consumption
Arm Title
Fasted Exercise
Arm Type
Experimental
Arm Description
6 weeks of moderate intensity exercise with breakfast omission
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Moderate intensity exercise
Intervention Type
Behavioral
Intervention Name(s)
Breakfast
Intervention Description
Breakfast consumption
Intervention Type
Behavioral
Intervention Name(s)
Maintain habitual habits
Intervention Description
Normal physical activity and dietary behaviors maintained
Primary Outcome Measure Information:
Title
Postprandial plasma glucose concentrations
Description
Response to oral glucose tolerance test (area under the curve)
Time Frame
120 mins - (change after 6 weeks)
Title
Postprandial insulin concentrations
Description
Response to oral glucose tolerance test (area under the curve)
Time Frame
120 mins - (change after 6 weeks)
Secondary Outcome Measure Information:
Title
Oral Glucose Insulin Sensitivity Index
Description
Response to oral glucose tolerance test
Time Frame
120 mins - (change after 6 weeks)
Title
Cardiorespiratory fitness (VO2max)
Time Frame
Change after 6 weeks
Title
Habitual energy intake
Description
Assessed via a food diary, completed at baseline and during the last week of the intervention
Time Frame
Change after 6 weeks
Title
Habitual energy expenditure
Description
Assessed via an Actiheart monitor, completed at baseline and during the last week of the intervention
Time Frame
Change after 6 weeks
Title
Body mass (kg)
Time Frame
Change after 6 weeks
Title
Waist and hip circumference (cm)
Time Frame
Change after 6 weeks
Title
Maximal rate of whole-body lipid oxidation (g/min)
Description
During an incremental exercise test
Time Frame
Change after 6 weeks
Title
Fasting plasma glucose concentration
Description
Fasting plasma glucose concentration (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Fasting plasma insulin concentration
Description
Fasting plasma insulin concentration (pmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Postprandial non-esterified fatty acid concentrations
Description
Response to oral glucose tolerance test (total and incremental area under the curve)
Time Frame
120 mins - (change after 6 weeks)
Title
Fasting plasma triglyceride concentrations
Description
Fasting plasma triglyceride concentrations (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Fasting plasma total cholesterol concentrations
Description
Fasting plasma total cholesterol concentrations (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Fasting plasma HDL cholesterol concentrations
Description
Fasting plasma HDL cholesterol concentrations (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Fasting plasma LDL cholesterol concentrations
Description
Fasting plasma LDL cholesterol concentrations (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Fasting plasma non-esterified fatty acid concentrations
Description
Fasting plasma non-esterified fatty acid concentrations (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Waist to hip ratio
Description
Waist circumference (cm) divided by hip circumference (cm)
Time Frame
Change after 6 weeks
Title
Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner)
Description
Skeletal muscle (vastus lateralis). Citrate Synthase Activity Assay Kit.
Time Frame
Change after 6 weeks
Title
Protein content of mitochondrial respiratory chain proteins
Description
Skeletal muscle (vastus lateralis). Complex I, Complex II, Complex III, Complex IV.
Time Frame
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units).
Title
Protein content of carnitine palmitoyltransferase I (CPT-1)
Description
Skeletal muscle (vastus lateralis)
Time Frame
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
Title
Protein content of cluster of differentiation 36 (CD36)
Description
Skeletal muscle (vastus lateralis)
Time Frame
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
Title
Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK)
Description
Skeletal muscle (vastus lateralis)
Time Frame
Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
Title
Resting metabolic rate (RMR)
Description
Assessed via indirect calirometry
Time Frame
Change after 6 weeks
Title
Energy balance
Description
Total energy expenditure minus total energy intake
Time Frame
Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
Title
Whole-body lipid utilisation during exercise
Description
Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Time Frame
Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
Title
Whole-body carbohydrate utilisation during exercise
Description
Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Time Frame
Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
Title
Homeostasis Model Assessment (HOMA2-IR)
Description
The Homeostasis Model Assessment (HOMA) estimate of steady state beta cell function (%B) and insulin sensitivity (%S). Derived from fasting plasma glucose and fasting plasma insulin concentrations.
Time Frame
Change after 6 weeks
Title
Fasting plasma glycerol concentrations
Description
Fasting plasma glycerol concentrations (mmol/L)
Time Frame
Basal Concentrations - (change after 6 weeks)
Title
Postprandial plasma glycerol concentrations
Description
Response to oral glucose tolerance test (total and incremental area under the curve)
Time Frame
Change after 6 weeks
Title
Adipose Tissue Insulin Resistance Index (Adipo-IR)
Description
Response to oral glucose tolerance test (total and incremental area under the curve)
Time Frame
Change after 6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male Aged 18-49 Body mass index (BMI) > 25 kg/m2 Weight stable for > 6 months Not currently engaging in any form of structured exercise Be able and willing to give informed oral and written consent Complete and meet the defined criteria of pre-study questionnaires and screen Exclusion Criteria: Have a history of metabolic, cardio-pulmonary or musculoskeletal disease Have plans to change diet and/or physical activity outside of the intervention Taking regular medication or food supplements from which it is not possible to refrain and which are known to influence any of the outcome measures. Failure to refrain from alcohol and/or caffeine containing drinks or strenuous exercise one day before or during the trial days Smokers Any reported condition or behavior deemed to pose a risk to the participant or introduce bias into the experiment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Gonzalez, PhD
Organizational Affiliation
University of Bath
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Health, University of Bath
City
Bath
ZIP/Postal Code
BA2 7AY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23340006
Citation
Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.
Results Reference
background
PubMed Identifier
20837645
Citation
Van Proeyen K, Szlufcik K, Nielens H, Pelgrim K, Deldicque L, Hesselink M, Van Veldhoven PP, Hespel P. Training in the fasted state improves glucose tolerance during fat-rich diet. J Physiol. 2010 Nov 1;588(Pt 21):4289-302. doi: 10.1113/jphysiol.2010.196493.
Results Reference
background
PubMed Identifier
31628477
Citation
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.
Results Reference
derived

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Training in the Fasted State, Glucose Metabolism and Energy Balance

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