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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Meal timing
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.
Other: Meal timing
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bath

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
Zoe Global Limited

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings