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Completed

NCT Number: NCT05279014

Fasted Exercise and LDL-C

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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Key information

Conditions

Cardiovascular Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in fasting plasma LDL-C concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma LDL-cholesterol concentrations (mmol/L)

Secondary outcomes

  1. Change in fasting plasma LDL-C concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma LDL-cholesterol concentrations (mmol/L)

  2. Change in fasting plasma HDL-C concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma HDL-cholesterol concentrations (mmol/L)

  3. Change in fasting plasma HDL-C concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma HDL-cholesterol concentrations (mmol/L)

  4. Change in fasting plasma total cholesterol concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma total cholesterol concentrations (mmol/L)

  5. Change in fasting plasma total cholesterol concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma total cholesterol concentrations (mmol/L)

  6. Change in fasting plasma apolipoprotein B concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma apolipoprotein B concentrations (mmol/L)

  7. Change in fasting plasma apolipoprotein B concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma apolipoprotein B concentrations (mmol/L)

  8. Change in fasting plasma triglyceride concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma triglyceride concentrations (mmol/L)

  9. Change in fasting plasma triglyceride concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma triglyceride concentrations (mmol/L)

  10. Change in fasting plasma C-reactive protein concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma C-reactive protein concentrations (mg/L)

  11. Change in fasting plasma C-reactive protein concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma C-reactive protein concentrations (mg/L)

  12. Change in fasting plasma glucose concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma glucose concentrations (mmol/L)

  13. Change in fasting plasma glucose concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma glucose concentrations (mmol/L)

  14. Change in fasting plasma insulin concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma insulin concentrations (mmol/L)

  15. Change in fasting plasma insulin concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma insulin concentrations (mmol/L)

  16. Change in fasting plasma non-esterified fatty acid concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma non-esterified fatty acid concentrations (mmol/L)

  17. Change in fasting plasma non-esterified fatty acid concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma non-esterified fatty acid concentrations (mmol/L)

  18. Change in 7-day mean interstitial glucose concentration at week 12

    Time frame: Baseline and week 12

    Mean interstitial glucose concentration (mmol/L) measured by continuous glucose monitor over a 7-day period

  19. Change in 7-day standard deviation of interstitial glucose concentration at week 12

    Time frame: Baseline and Week 12

    Standard deviation of interstitial glucose concentration (mmol/L) measured by continuous glucose monitor over a 7-day period

  20. Change in 7-day coefficient of variation for interstitial glucose concentration at week 12

    Time frame: Baseline and week 12.

    Coefficient of variation for interstitial glucose concentration (%) measured by continuous glucose monitor over a 7-day period

  21. Change in 7-day mean amplitude of glycaemic excursions for interstitial glucose at week 12

    Time frame: Baseline and week 12.

    Mean amplitude of glycaemic excursions for interstitial glucose (mmol/L) measured by continuous glucose monitor over a 7-day period

Other outcomes

  1. Change in fasting plasma VLDL-rich triglyceride concentrations at week 12

    Time frame: Baseline and week 12

    Fasting plasma VLDL-rich triglyceride concentrations (mmol/L)

  2. Change in fasting plasma VLDL-rich triglyceride concentrations at week 4

    Time frame: Baseline and week 4

    Fasting plasma VLDL-rich triglyceride concentrations (mmol/L)

  3. Change in body mass at week 12

    Time frame: Baseline and week 12

    Body mass (kg)

  4. Change in body mass at week 4

    Time frame: Baseline and week 4

    Body mass (kg)

  5. Change in waist-to-hit ratio at week 12

    Time frame: Baseline and week 12

    Waist-to-hit ratio

  6. Change in waist-to-hit ratio at week 4

    Time frame: Baseline and week 4

    Waist-to-hit ratio

  7. Change in fat mass at week 12

    Time frame: Baseline and week 12

    Fat mass determined by dual-energy x-ray absorptiometry (kg)

  8. Change in fat mass at week 4

    Time frame: Baseline and week 4

    Fat mass determined by dual-energy x-ray absorptiometry (kg)

  9. Change in fat-free mass at week 12

    Time frame: Baseline and week 12

    Fat-free mass determined by dual-energy x-ray absorptiometry (kg)

  10. Change in fat-free mass at week 4

    Time frame: Baseline and week 4

    Fat-free mass determined by dual-energy x-ray absorptiometry (kg)

  11. Change in sagittal abdominal diameter at week 12

    Time frame: Baseline and week 12

    Sagittal abdominal diameter (cm)

  12. Change in sagittal abdominal diameter at week 4

    Time frame: Baseline and week 4

    Sagittal abdominal diameter (cm)

  13. Change in gut microbiome species richness at week 12

    Time frame: Baseline and week 12

    Species count in fecal sample (as part of ZOE testing program)

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Collaborators

  • King's College London
  • Zoe Global Limited

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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