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Training in the Fasted State, Glucose Metabolism and Energy Balance

Training in the Fasted State, Glucose Metabolism and Energy Balance

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02744183
Enrollment
30
Registered
2016-04-20
Start date
2016-10-31
Completion date
2019-09-30
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Metabolism Disorders

Keywords

Exercise, Fasted, Glucose, Energy Balance

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.

Interventions

BEHAVIORALExercise

Moderate intensity exercise

BEHAVIORALBreakfast

Breakfast consumption

BEHAVIORALMaintain habitual habits

Normal physical activity and dietary behaviors maintained

Sponsors

University of Bath
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postprandial plasma glucose concentrations120 mins - (change after 6 weeks)Response to oral glucose tolerance test (area under the curve)
Postprandial insulin concentrations120 mins - (change after 6 weeks)Response to oral glucose tolerance test (area under the curve)

Secondary

MeasureTime frameDescription
Cardiorespiratory fitness (VO2max)Change after 6 weeks
Habitual energy intakeChange after 6 weeksAssessed via a food diary, completed at baseline and during the last week of the intervention
Habitual energy expenditureChange after 6 weeksAssessed via an Actiheart monitor, completed at baseline and during the last week of the intervention
Body mass (kg)Change after 6 weeks
Waist and hip circumference (cm)Change after 6 weeks
Maximal rate of whole-body lipid oxidation (g/min)Change after 6 weeksDuring an incremental exercise test
Fasting plasma glucose concentrationBasal Concentrations - (change after 6 weeks)Fasting plasma glucose concentration (mmol/L)
Fasting plasma insulin concentrationBasal Concentrations - (change after 6 weeks)Fasting plasma insulin concentration (pmol/L)
Whole-body lipid utilisation during exerciseChange throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Postprandial non-esterified fatty acid concentrations120 mins - (change after 6 weeks)Response to oral glucose tolerance test (total and incremental area under the curve)
Fasting plasma triglyceride concentrationsBasal Concentrations - (change after 6 weeks)Fasting plasma triglyceride concentrations (mmol/L)
Fasting plasma total cholesterol concentrationsBasal Concentrations - (change after 6 weeks)Fasting plasma total cholesterol concentrations (mmol/L)
Fasting plasma HDL cholesterol concentrationsBasal Concentrations - (change after 6 weeks)Fasting plasma HDL cholesterol concentrations (mmol/L)
Energy balanceChange after 6 weeks (during week 6 of intervention versus baseline monitoring)Total energy expenditure minus total energy intake
Fasting plasma non-esterified fatty acid concentrationsBasal Concentrations - (change after 6 weeks)Fasting plasma non-esterified fatty acid concentrations (mmol/L)
Waist to hip ratioChange after 6 weeksWaist circumference (cm) divided by hip circumference (cm)
Citrate Synthase Activity (mitochondrial citrate synthase activity in each muscle sample in an immunocapture based manner)Change after 6 weeksSkeletal muscle (vastus lateralis). Citrate Synthase Activity Assay Kit.
Protein content of mitochondrial respiratory chain proteinsChange after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units).Skeletal muscle (vastus lateralis). Complex I, Complex II, Complex III, Complex IV.
Protein content of carnitine palmitoyltransferase I (CPT-1)Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)Skeletal muscle (vastus lateralis)
Protein content of cluster of differentiation 36 (CD36)Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)Skeletal muscle (vastus lateralis)
Protein content (total and phosphorylated form) of AMP-activated protein kinase (AMPK)Change after 6 weeks. For each participant the protein content will be presented as the fold change from baseline (arbitrary units)Skeletal muscle (vastus lateralis)
Resting metabolic rate (RMR)Change after 6 weeksAssessed via indirect calirometry
Whole-body carbohydrate utilisation during exerciseChange throughout complete training period (weeks 1 through to 6). Samples will be collected during every training session (three times weekly for six weeks)Assessed via indirect calirometry during every exercise session (at ten minute intervals)
Homeostasis Model Assessment (HOMA2-IR)Change after 6 weeksThe 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 concentrationsBasal Concentrations - (change after 6 weeks)Fasting plasma glycerol concentrations (mmol/L)
Postprandial plasma glycerol concentrationsChange after 6 weeksResponse to oral glucose tolerance test (total and incremental area under the curve)
Adipose Tissue Insulin Resistance Index (Adipo-IR)Change after 6 weeksResponse to oral glucose tolerance test (total and incremental area under the curve)
Fasting plasma LDL cholesterol concentrationsBasal Concentrations - (change after 6 weeks)Fasting plasma LDL cholesterol concentrations (mmol/L)
Oral Glucose Insulin Sensitivity Index120 mins - (change after 6 weeks)Response to oral glucose tolerance test

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026