Fasted Exercise and LDL-C

NCT05279014 | Completed

• 1 other identifier: EIRA1-7137
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in fasting plasma LDL-C concentrations at week 12

  Fasting plasma LDL-cholesterol concentrations (mmol/L)

  Baseline and week 12

Secondary Outcomes (21)

• Change in fasting plasma LDL-C concentrations at week 4

  Baseline and week 4

• Change in fasting plasma HDL-C concentrations at week 12

  Baseline and week 12

• Change in fasting plasma HDL-C concentrations at week 4

  Baseline and week 4

• Change in fasting plasma total cholesterol concentrations at week 12

  Baseline and week 12

• Change in fasting plasma total cholesterol concentrations at week 4

  Baseline and week 4

Other Outcomes (13)

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

  Baseline and week 12

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

  Baseline and week 4

• Change in body mass at week 12

  Baseline and week 12

Study Arms (2)

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).

Other: Meal timing

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.

Other: Meal timing

Interventions

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.

Exercise in a fasted-state; Exercise in a fed-state

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-65 years
• Body mass index 20-40kg/m2
• Physically inactive (exercise for less than 150 minutes per week)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bath: lead
• King's College London: collaborator
• Zoe Global Limited: collaborator

Study Sites (1)

Department for Health, University of Bath

Bath, Bath, BA2 7AY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31628477 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.

  PMID: 33428210 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 15, 2022
• Study Start: March 30, 2022
• Primary Completion: August 13, 2024
• Study Completion: August 30, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

GB (1)