Fasted Exercise and LDL-C

March 24, 2025 updated by: Louise Bradshaw, University of Bath

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bath, United Kingdom, BA2 7AY
        • Department for Health, University of Bath

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise in a fed-state
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).
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.
Experimental: Exercise in a fasted-state
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting plasma LDL-C concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma LDL-cholesterol concentrations (mmol/L)
Baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting plasma LDL-C concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma LDL-cholesterol concentrations (mmol/L)
Baseline and week 4
Change in fasting plasma HDL-C concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma HDL-cholesterol concentrations (mmol/L)
Baseline and week 12
Change in fasting plasma HDL-C concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma HDL-cholesterol concentrations (mmol/L)
Baseline and week 4
Change in fasting plasma total cholesterol concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma total cholesterol concentrations (mmol/L)
Baseline and week 12
Change in fasting plasma total cholesterol concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma total cholesterol concentrations (mmol/L)
Baseline and week 4
Change in fasting plasma apolipoprotein B concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma apolipoprotein B concentrations (mmol/L)
Baseline and week 12
Change in fasting plasma apolipoprotein B concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma apolipoprotein B concentrations (mmol/L)
Baseline and week 4
Change in fasting plasma triglyceride concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma triglyceride concentrations (mmol/L)
Baseline and week 12
Change in fasting plasma triglyceride concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma triglyceride concentrations (mmol/L)
Baseline and week 4
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)
Baseline and week 12
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)
Baseline and week 4
Change in fasting plasma glucose concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma glucose concentrations (mmol/L)
Baseline and week 12
Change in fasting plasma glucose concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma glucose concentrations (mmol/L)
Baseline and week 4
Change in fasting plasma insulin concentrations at week 12
Time Frame: Baseline and week 12
Fasting plasma insulin concentrations (mmol/L)
Baseline and week 12
Change in fasting plasma insulin concentrations at week 4
Time Frame: Baseline and week 4
Fasting plasma insulin concentrations (mmol/L)
Baseline and week 4
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)
Baseline and week 12
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)
Baseline and week 4
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
Baseline and week 12
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
Baseline and Week 12
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
Baseline and week 12.
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
Baseline and week 12.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline and week 12
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)
Baseline and week 4
Change in body mass at week 12
Time Frame: Baseline and week 12
Body mass (kg)
Baseline and week 12
Change in body mass at week 4
Time Frame: Baseline and week 4
Body mass (kg)
Baseline and week 4
Change in waist-to-hit ratio at week 12
Time Frame: Baseline and week 12
Waist-to-hit ratio
Baseline and week 12
Change in waist-to-hit ratio at week 4
Time Frame: Baseline and week 4
Waist-to-hit ratio
Baseline and week 4
Change in fat mass at week 12
Time Frame: Baseline and week 12
Fat mass determined by dual-energy x-ray absorptiometry (kg)
Baseline and week 12
Change in fat mass at week 4
Time Frame: Baseline and week 4
Fat mass determined by dual-energy x-ray absorptiometry (kg)
Baseline and week 4
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)
Baseline and week 12
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)
Baseline and week 4
Change in sagittal abdominal diameter at week 12
Time Frame: Baseline and week 12
Sagittal abdominal diameter (cm)
Baseline and week 12
Change in sagittal abdominal diameter at week 4
Time Frame: Baseline and week 4
Sagittal abdominal diameter (cm)
Baseline and week 4
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)
Baseline and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Actual)

August 13, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIRA1-7137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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