Fasted Exercise and LDL-C

Study Overview
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Brief Summary
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Cardiovascular disease (CVD) is the leading cause of death in the UK and worldwide with low density lipoprotein cholesterol (LDL-C) being one of the most important modifiable risk factors. Physical activity is inexpensive and research shows that it consistently improves high density lipoprotein and triglyceride concentrations. However, fails to improve LDL-C concentrations. Preliminary research suggests fasted exercise could potentially improve LDL-C concentrations. The majority of research in these areas have also mostly been done in males with the results generalised to females. As it is known that lipid metabolism and CVD risk is different between sexes it is possible that the response to fasted exercise may also be different between sexes. This aim of this study is to assess the effect of physical activity performed before or after a meal on plasma LDL-C concentrations in men and women and explore sex differences. The study will also assess the effect of fasted exercise on other CVD risk factors.

Official Title
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The Effect of Fasted Exercise on LDL-cholesterol in Men and Women

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Meal timing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Body mass index 20-40kg/m2 Physically inactive (exercise for less than 150 minutes per week) Exclusion Criteria: Weight instability (>5kg change in body mass over last 6 months) Diagnosis of diabetes or CVD Pregnant or lactating Any medical condition or medication that could introduce bias into the study (eg. lipid disorders, lipid or glucose metabolism altering medications eg statins)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise in a fed-state<br>12-weeks of exercise training, 50-minutes, 3 days per week performed 1.5-3 hours after a high-carbohydrate meal (1 g/kg body mass). | Other: Meal timing<br>* A high-carbohydrate (1 g/kg body mass) meal to be consumed either 1.5-3 hours before or immediately after exercise. Those consuming the meal after exercise will have fasted for at least 8 hours before exercise.<br>|
| Experimental: Exercise in a fasted-state<br>12-weeks of exercise training, 50-minutes, 3 days per week performed after at least an 8-hour fast. A high-carbohydrate meal (1 g/kg body mass) will be consumed after exercise. | Other: Meal timing<br>* A high-carbohydrate (1 g/kg body mass) meal to be consumed either 1.5-3 hours before or immediately after exercise. Those consuming the meal after exercise will have fasted for at least 8 hours before exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma LDL-C concentrations at week 12 | Fasting plasma LDL-cholesterol concentrations (mmol/L) | Baseline and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma LDL-C concentrations at week 4 | Fasting plasma LDL-cholesterol concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma HDL-C concentrations at week 12 | Fasting plasma HDL-cholesterol concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma HDL-C concentrations at week 4 | Fasting plasma HDL-cholesterol concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma total cholesterol concentrations at week 12 | Fasting plasma total cholesterol concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma total cholesterol concentrations at week 4 | Fasting plasma total cholesterol concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma apolipoprotein B concentrations at week 12 | Fasting plasma apolipoprotein B concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma apolipoprotein B concentrations at week 4 | Fasting plasma apolipoprotein B concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma triglyceride concentrations at week 12 | Fasting plasma triglyceride concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma triglyceride concentrations at week 4 | Fasting plasma triglyceride concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma C-reactive protein concentrations at week 12 | Fasting plasma C-reactive protein concentrations (mg/L) | Baseline and week 12 | 
| Change in fasting plasma C-reactive protein concentrations at week 4 | Fasting plasma C-reactive protein concentrations (mg/L) | Baseline and week 4 | 
| Change in fasting plasma glucose concentrations at week 12 | Fasting plasma glucose concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma glucose concentrations at week 4 | Fasting plasma glucose concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma insulin concentrations at week 12 | Fasting plasma insulin concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma insulin concentrations at week 4 | Fasting plasma insulin concentrations (mmol/L) | Baseline and week 4 | 
| Change in fasting plasma non-esterified fatty acid concentrations at week 12 | Fasting plasma non-esterified fatty acid concentrations (mmol/L) | Baseline and week 12 | 
| Change in fasting plasma non-esterified fatty acid concentrations at week 4 | Fasting plasma non-esterified fatty acid concentrations (mmol/L) | Baseline and week 4 | 
| Change in 7-day mean interstitial glucose concentration at week 12 | Mean interstitial glucose concentration (mmol/L) measured by continuous glucose monitor over a 7-day period | Baseline and week 12 | 
| Change in 7-day standard deviation of interstitial glucose concentration at week 12 | Standard deviation of interstitial glucose concentration (mmol/L) measured by continuous glucose monitor over a 7-day period | Baseline and Week 12 | 
| Change in 7-day coefficient of variation for interstitial glucose concentration at week 12 | Coefficient of variation for interstitial glucose concentration (%) measured by continuous glucose monitor over a 7-day period | Baseline and week 12. | 
| Change in 7-day mean amplitude of glycaemic excursions for interstitial glucose at week 12 | Mean amplitude of glycaemic excursions for interstitial glucose (mmol/L) measured by continuous glucose monitor over a 7-day period | Baseline and week 12. |