Clinical trial NCT05279014: Fasted Exercise and LDL-C
Official title: The Effect of Fasted Exercise on LDL-cholesterol in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: King's College London
name: Zoe Global Limited
First posted: 2022-03-15
Enrollment: 29
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in fasting plasma LDL-C concentrations at week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change in fasting plasma LDL-C concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma HDL-C concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma HDL-C concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma total cholesterol concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma total cholesterol concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma apolipoprotein B concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma apolipoprotein B concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma triglyceride concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma triglyceride concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma C-reactive protein concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma C-reactive protein concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma glucose concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma glucose concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma insulin concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma insulin concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in fasting plasma non-esterified fatty acid concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma non-esterified fatty acid concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in 7-day mean interstitial glucose concentration at week 12
timeFrame: Baseline and week 12
measure: Change in 7-day standard deviation of interstitial glucose concentration at week 12
timeFrame: Baseline and Week 12
measure: Change in 7-day coefficient of variation for interstitial glucose concentration at week 12
timeFrame: Baseline and week 12.
measure: Change in 7-day mean amplitude of glycaemic excursions for interstitial glucose at week 12
timeFrame: Baseline and week 12.
Other outcomes:
measure: Change in fasting plasma VLDL-rich triglyceride concentrations at week 12
timeFrame: Baseline and week 12
measure: Change in fasting plasma VLDL-rich triglyceride concentrations at week 4
timeFrame: Baseline and week 4
measure: Change in body mass at week 12
timeFrame: Baseline and week 12
measure: Change in body mass at week 4
timeFrame: Baseline and week 4
measure: Change in waist-to-hit ratio at week 12
timeFrame: Baseline and week 12
measure: Change in waist-to-hit ratio at week 4
timeFrame: Baseline and week 4
measure: Change in fat mass at week 12
timeFrame: Baseline and week 12
measure: Change in fat mass at week 4
timeFrame: Baseline and week 4
measure: Change in fat-free mass at week 12
timeFrame: Baseline and week 12
measure: Change in fat-free mass at week 4
timeFrame: Baseline and week 4
measure: Change in sagittal abdominal diameter at week 12
timeFrame: Baseline and week 12
measure: Change in sagittal abdominal diameter at week 4
timeFrame: Baseline and week 4
measure: Change in gut microbiome species richness at week 12
timeFrame: Baseline and week 12
Locations:
city: Bath
country: United Kingdom
facility: Department for Health, University of Bath
Study officials:
References:
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.
citation: 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.