Training in the Fasted State, Glucose Metabolism and Energy Balance

Glucose Metabolism Disorders Clinical Trial

Official title:

Training in the Fasted State, Glucose Metabolism and Energy Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744183
• Other study ID #: EP 15/16129
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2019

Study information

• Verified date: November 2022
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Behavioral:
• Exercise
Moderate intensity exercise
• Breakfast
Breakfast consumption
• Maintain habitual habits
Normal physical activity and dietary behaviors maintained

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial plasma glucose concentrations	Response to oral glucose tolerance test (area under the curve)	120 mins - (change after 6 weeks)
Primary	Postprandial insulin concentrations	Response to oral glucose tolerance test (area under the curve)	120 mins - (change after 6 weeks)
Secondary	Oral Glucose Insulin Sensitivity Index	Response to oral glucose tolerance test	120 mins - (change after 6 weeks)
Secondary	Cardiorespiratory fitness (VO2max)		Change after 6 weeks
Secondary	Habitual energy intake	Assessed via a food diary, completed at baseline and during the last week of the intervention	Change after 6 weeks
Secondary	Habitual energy expenditure	Assessed via an Actiheart monitor, completed at baseline and during the last week of the intervention	Change after 6 weeks
Secondary	Body mass (kg)		Change after 6 weeks
Secondary	Waist and hip circumference (cm)		Change after 6 weeks
Secondary	Maximal rate of whole-body lipid oxidation (g/min)	During an incremental exercise test	Change after 6 weeks
Secondary	Fasting plasma glucose concentration	Fasting plasma glucose concentration (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Fasting plasma insulin concentration	Fasting plasma insulin concentration (pmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Postprandial non-esterified fatty acid concentrations	Response to oral glucose tolerance test (total and incremental area under the curve)	120 mins - (change after 6 weeks)
Secondary	Fasting plasma triglyceride concentrations	Fasting plasma triglyceride concentrations (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Fasting plasma total cholesterol concentrations	Fasting plasma total cholesterol concentrations (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Fasting plasma HDL cholesterol concentrations	Fasting plasma HDL cholesterol concentrations (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Fasting plasma LDL cholesterol concentrations	Fasting plasma LDL cholesterol concentrations (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Fasting plasma non-esterified fatty acid concentrations	Fasting plasma non-esterified fatty acid concentrations (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Waist to hip ratio	Waist circumference (cm) divided by hip circumference (cm)	Change after 6 weeks
Secondary	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.	Change after 6 weeks
Secondary	Protein content of mitochondrial respiratory chain proteins	Skeletal muscle (vastus lateralis). Complex I, Complex II, Complex III, Complex IV.	Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units).
Secondary	Protein content of carnitine palmitoyltransferase I (CPT-1)	Skeletal muscle (vastus lateralis)	Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
Secondary	Protein content of cluster of differentiation 36 (CD36)	Skeletal muscle (vastus lateralis)	Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
Secondary	Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK)	Skeletal muscle (vastus lateralis)	Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
Secondary	Resting metabolic rate (RMR)	Assessed via indirect calirometry	Change after 6 weeks
Secondary	Energy balance	Total energy expenditure minus total energy intake	Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
Secondary	Whole-body lipid utilisation during exercise	Assessed via indirect calirometry during every exercise session (at ten minute intervals)	Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
Secondary	Whole-body carbohydrate utilisation during exercise	Assessed via indirect calirometry during every exercise session (at ten minute intervals)	Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
Secondary	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.	Change after 6 weeks
Secondary	Fasting plasma glycerol concentrations	Fasting plasma glycerol concentrations (mmol/L)	Basal Concentrations - (change after 6 weeks)
Secondary	Postprandial plasma glycerol concentrations	Response to oral glucose tolerance test (total and incremental area under the curve)	Change after 6 weeks
Secondary	Adipose Tissue Insulin Resistance Index (Adipo-IR)	Response to oral glucose tolerance test (total and incremental area under the curve)	Change after 6 weeks