Clinical trial NCT02744183: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Keywords: Exercise
Fasted
Glucose
Energy Balance
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Postprandial plasma glucose concentrations
timeFrame: 120 mins - (change after 6 weeks)
measure: Postprandial insulin concentrations
timeFrame: 120 mins - (change after 6 weeks)
Secondary outcomes:
measure: Oral Glucose Insulin Sensitivity Index
timeFrame: 120 mins - (change after 6 weeks)
measure: Cardiorespiratory fitness (VO2max)
timeFrame: Change after 6 weeks
measure: Habitual energy intake
timeFrame: Change after 6 weeks
measure: Habitual energy expenditure
timeFrame: Change after 6 weeks
measure: Body mass (kg)
timeFrame: Change after 6 weeks
measure: Waist and hip circumference (cm)
timeFrame: Change after 6 weeks
measure: Maximal rate of whole-body lipid oxidation (g/min)
timeFrame: Change after 6 weeks
measure: Fasting plasma glucose concentration
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Fasting plasma insulin concentration
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Postprandial non-esterified fatty acid concentrations
timeFrame: 120 mins - (change after 6 weeks)
measure: Fasting plasma triglyceride concentrations
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Fasting plasma total cholesterol concentrations
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Fasting plasma HDL cholesterol concentrations
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Fasting plasma LDL cholesterol concentrations
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Fasting plasma non-esterified fatty acid concentrations
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Waist to hip ratio
timeFrame: Change after 6 weeks
measure: Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner)
timeFrame: Change after 6 weeks
measure: Protein content of mitochondrial respiratory chain proteins
timeFrame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units).
measure: Protein content of carnitine palmitoyltransferase I (CPT-1)
timeFrame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
measure: Protein content of cluster of differentiation 36 (CD36)
timeFrame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
measure: Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK)
timeFrame: Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)
measure: Resting metabolic rate (RMR)
timeFrame: Change after 6 weeks
measure: Energy balance
timeFrame: Change after 6 weeks (during week 6 of intervention versus baseline monitoring)
measure: Whole-body lipid utilisation during exercise
timeFrame: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
measure: Whole-body carbohydrate utilisation during exercise
timeFrame: Change throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)
measure: Homeostasis Model Assessment (HOMA2-IR)
timeFrame: Change after 6 weeks
measure: Fasting plasma glycerol concentrations
timeFrame: Basal Concentrations - (change after 6 weeks)
measure: Postprandial plasma glycerol concentrations
timeFrame: Change after 6 weeks
measure: Adipose Tissue Insulin Resistance Index (Adipo-IR)
timeFrame: Change after 6 weeks
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
affiliation: University of Bath
name: Javier Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.