Cardiovascular Diseases
Conditions
Brief summary
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.
Interventions
OTHERMeal timing
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.
Sponsors
King's College London
Zoe Global Limited
University of Bath
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma LDL-C concentrations at week 12 | Baseline and week 12 | Fasting plasma LDL-cholesterol concentrations (mmol/L) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting plasma total cholesterol concentrations at week 4 | Baseline and week 4 | Fasting plasma total cholesterol concentrations (mmol/L) |
| Change in fasting plasma triglyceride concentrations at week 4 | Baseline and week 4 | Fasting plasma triglyceride concentrations (mmol/L) |
| Change in fasting plasma C-reactive protein concentrations at week 12 | Baseline and week 12 | Fasting plasma C-reactive protein concentrations (mg/L) |
| Change in fasting plasma C-reactive protein concentrations at week 4 | Baseline and week 4 | Fasting plasma C-reactive protein concentrations (mg/L) |
| Change in fasting plasma glucose concentrations at week 12 | Baseline and week 12 | Fasting plasma glucose concentrations (mmol/L) |
| Change in fasting plasma glucose concentrations at week 4 | Baseline and week 4 | Fasting plasma glucose concentrations (mmol/L) |
| Change in fasting plasma insulin concentrations at week 12 | Baseline and week 12 | Fasting plasma insulin concentrations (mmol/L) |
| Change in fasting plasma insulin concentrations at week 4 | Baseline and week 4 | Fasting plasma insulin concentrations (mmol/L) |
| Change in fasting plasma non-esterified fatty acid concentrations at week 12 | Baseline and week 12 | Fasting plasma non-esterified fatty acid concentrations (mmol/L) |
| Change in fasting plasma non-esterified fatty acid concentrations at week 4 | Baseline and week 4 | Fasting plasma non-esterified fatty acid concentrations (mmol/L) |
| Change in 7-day mean interstitial glucose concentration at week 12 | Baseline and week 12 | Mean interstitial glucose concentration (mmol/L) measured by continuous glucose monitor over a 7-day period |
| Change in 7-day standard deviation of interstitial glucose concentration at week 12 | Baseline and Week 12 | Standard deviation of interstitial glucose concentration (mmol/L) measured by continuous glucose monitor over a 7-day period |
| Change in 7-day coefficient of variation for interstitial glucose concentration at week 12 | Baseline and week 12. | Coefficient of variation for interstitial glucose concentration (%) measured by continuous glucose monitor over a 7-day period |
| Change in 7-day mean amplitude of glycaemic excursions for interstitial glucose at week 12 | Baseline and week 12. | Mean amplitude of glycaemic excursions for interstitial glucose (mmol/L) measured by continuous glucose monitor over a 7-day period |
| Change in fasting plasma LDL-C concentrations at week 4 | Baseline and week 4 | Fasting plasma LDL-cholesterol concentrations (mmol/L) |
| Change in fasting plasma HDL-C concentrations at week 12 | Baseline and week 12 | Fasting plasma HDL-cholesterol concentrations (mmol/L) |
| Change in fasting plasma HDL-C concentrations at week 4 | Baseline and week 4 | Fasting plasma HDL-cholesterol concentrations (mmol/L) |
| Change in fasting plasma total cholesterol concentrations at week 12 | Baseline and week 12 | Fasting plasma total cholesterol concentrations (mmol/L) |
| Change in fasting plasma apolipoprotein B concentrations at week 12 | Baseline and week 12 | Fasting plasma apolipoprotein B concentrations (mmol/L) |
| Change in fasting plasma apolipoprotein B concentrations at week 4 | Baseline and week 4 | Fasting plasma apolipoprotein B concentrations (mmol/L) |
| Change in fasting plasma triglyceride concentrations at week 12 | Baseline and week 12 | Fasting plasma triglyceride concentrations (mmol/L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass at week 12 | Baseline and week 12 | Body mass (kg) |
| Change in body mass at week 4 | Baseline and week 4 | Body mass (kg) |
| Change in waist-to-hit ratio at week 12 | Baseline and week 12 | Waist-to-hit ratio |
| Change in waist-to-hit ratio at week 4 | Baseline and week 4 | Waist-to-hit ratio |
| Change in fat mass at week 12 | Baseline and week 12 | Fat mass determined by dual-energy x-ray absorptiometry (kg) |
| Change in fat mass at week 4 | Baseline and week 4 | Fat mass determined by dual-energy x-ray absorptiometry (kg) |
| Change in fat-free mass at week 12 | Baseline and week 12 | Fat-free mass determined by dual-energy x-ray absorptiometry (kg) |
| Change in fat-free mass at week 4 | Baseline and week 4 | Fat-free mass determined by dual-energy x-ray absorptiometry (kg) |
| Change in sagittal abdominal diameter at week 12 | Baseline and week 12 | Sagittal abdominal diameter (cm) |
| Change in sagittal abdominal diameter at week 4 | Baseline and week 4 | Sagittal abdominal diameter (cm) |
| Change in gut microbiome species richness at week 12 | Baseline and week 12 | Species count in fecal sample (as part of ZOE testing program) |
| Change in fasting plasma VLDL-rich triglyceride concentrations at week 12 | Baseline and week 12 | Fasting plasma VLDL-rich triglyceride concentrations (mmol/L) |
| Change in fasting plasma VLDL-rich triglyceride concentrations at week 4 | Baseline and week 4 | Fasting plasma VLDL-rich triglyceride concentrations (mmol/L) |
Countries
United Kingdom
Outcome results
None listed