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| Name | Class |
|---|---|
| King's College London | OTHER |
| Zoe Global Limited | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise in a fed-state | Active Comparator | 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). |
|
| Exercise in a fasted-state | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal timing | Other | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting plasma VLDL-rich triglyceride concentrations at week 12 | Fasting plasma VLDL-rich triglyceride concentrations (mmol/L) | Baseline and week 12 |
| Change in fasting plasma VLDL-rich triglyceride concentrations at week 4 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Health, University of Bath | Bath | Bath | BA2 7AY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31628477 | Background | 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. | |
| 33428210 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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. |
Fasting plasma VLDL-rich triglyceride concentrations (mmol/L)
| Baseline and week 4 |
| Change in body mass at week 12 | Body mass (kg) | Baseline and week 12 |
| Change in body mass at week 4 | Body mass (kg) | Baseline and week 4 |
| Change in waist-to-hit ratio at week 12 | Waist-to-hit ratio | Baseline and week 12 |
| Change in waist-to-hit ratio at week 4 | Waist-to-hit ratio | Baseline and week 4 |
| Change in fat mass at week 12 | Fat mass determined by dual-energy x-ray absorptiometry (kg) | Baseline and week 12 |
| Change in fat mass at week 4 | Fat mass determined by dual-energy x-ray absorptiometry (kg) | Baseline and week 4 |
| Change in fat-free mass at week 12 | Fat-free mass determined by dual-energy x-ray absorptiometry (kg) | Baseline and week 12 |
| Change in fat-free mass at week 4 | Fat-free mass determined by dual-energy x-ray absorptiometry (kg) | Baseline and week 4 |
| Change in sagittal abdominal diameter at week 12 | Sagittal abdominal diameter (cm) | Baseline and week 12 |
| Change in sagittal abdominal diameter at week 4 | Sagittal abdominal diameter (cm) | Baseline and week 4 |
| Change in gut microbiome species richness at week 12 | Species count in fecal sample (as part of ZOE testing program) | Baseline and week 12 |
| Background |
| Edinburgh RM, Koumanov F, Gonzalez JT. Impact of pre-exercise feeding status on metabolic adaptations to endurance-type exercise training. J Physiol. 2022 Mar;600(6):1327-1338. doi: 10.1113/JP280748. Epub 2021 Jan 27. |