Fasted Exercise and LDL-C

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Other: Meal timing

• Registration Number: NCT05279014
• Lead Sponsor: University of Bath

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-15
• Study Start: 2022-03-30
• Primary Completion: 2024-08-13
• Study Completion: 2024-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise in a fed-state	Meal timing	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	Meal timing	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.

Primary Outcome Measures

Name	Time	Method
Change in fasting plasma LDL-C concentrations at week 12	Baseline and week 12	Fasting plasma LDL-cholesterol concentrations (mmol/L)

Secondary Outcome Measures

Name	Time	Method
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 12	Baseline and week 12	Fasting plasma triglyceride 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 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 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 glucose concentrations at week 4	Baseline and week 4	Fasting plasma glucose 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 insulin concentrations at week 12	Baseline and week 12	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 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 C-reactive protein concentrations at week 4	Baseline and week 4	Fasting plasma C-reactive protein concentrations (mg/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 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 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 4	Baseline and week 4	Fasting plasma HDL-cholesterol concentrations (mmol/L)
Change in fasting plasma glucose concentrations at week 12	Baseline and week 12	Fasting plasma glucose concentrations (mmol/L)
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

Trial Locations

Locations (1)

Department for Health, University of Bath; 🇬🇧 Bath, United Kingdom