- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05279014
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
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
-
-
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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).
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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.
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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.
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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.
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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
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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
|
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Change in fasting plasma HDL-C concentrations at week 12
Time Frame: Baseline and week 12
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Fasting plasma HDL-cholesterol concentrations (mmol/L)
|
Baseline and week 12
|
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Change in fasting plasma HDL-C concentrations at week 4
Time Frame: Baseline and week 4
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Fasting plasma HDL-cholesterol concentrations (mmol/L)
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Baseline and week 4
|
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Change in fasting plasma total cholesterol concentrations at week 12
Time Frame: Baseline and week 12
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Fasting plasma total cholesterol concentrations (mmol/L)
|
Baseline and week 12
|
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Change in fasting plasma total cholesterol concentrations at week 4
Time Frame: Baseline and week 4
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Fasting plasma total cholesterol concentrations (mmol/L)
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Baseline and week 4
|
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Change in fasting plasma apolipoprotein B concentrations at week 12
Time Frame: Baseline and week 12
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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
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Fasting plasma glucose concentrations (mmol/L)
|
Baseline and week 12
|
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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
|
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Change in fasting plasma insulin concentrations at week 12
Time Frame: Baseline and week 12
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Fasting plasma insulin concentrations (mmol/L)
|
Baseline and week 12
|
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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
|
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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.
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Coefficient of variation for interstitial glucose concentration (%) measured by continuous glucose monitor over a 7-day period
|
Baseline and week 12.
|
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Change in 7-day mean amplitude of glycaemic excursions for interstitial glucose at week 12
Time Frame: Baseline and week 12.
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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
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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
|
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Change in body mass at week 4
Time Frame: Baseline and week 4
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Body mass (kg)
|
Baseline and week 4
|
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Change in waist-to-hit ratio at week 12
Time Frame: Baseline and week 12
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Waist-to-hit ratio
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Baseline and week 12
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Change in waist-to-hit ratio at week 4
Time Frame: Baseline and week 4
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Waist-to-hit ratio
|
Baseline and week 4
|
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Change in fat mass at week 12
Time Frame: Baseline and week 12
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Fat mass determined by dual-energy x-ray absorptiometry (kg)
|
Baseline and week 12
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Change in fat mass at week 4
Time Frame: Baseline and week 4
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Fat mass determined by dual-energy x-ray absorptiometry (kg)
|
Baseline and week 4
|
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Change in fat-free mass at week 12
Time Frame: Baseline and week 12
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Fat-free mass determined by dual-energy x-ray absorptiometry (kg)
|
Baseline and week 12
|
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Change in fat-free mass at week 4
Time Frame: Baseline and week 4
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Fat-free mass determined by dual-energy x-ray absorptiometry (kg)
|
Baseline and week 4
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Change in sagittal abdominal diameter at week 12
Time Frame: Baseline and week 12
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Sagittal abdominal diameter (cm)
|
Baseline and week 12
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Change in sagittal abdominal diameter at week 4
Time Frame: Baseline and week 4
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Sagittal abdominal diameter (cm)
|
Baseline and week 4
|
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Change in gut microbiome species richness at week 12
Time Frame: Baseline and week 12
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Species count in fecal sample (as part of ZOE testing program)
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Baseline and week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- 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.
- 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.
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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