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Cardiovascular DiseasesNCT05279014

Fasted Exercise and LDL-C

A study testing Meal timing in people with Cardiovascular Diseases, run by University of Bath at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Meal timing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited Kingdom
Study dates
30 Mar 2022to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Department for Health, University of Bath

    Bath, Bath, BA2 7AY

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Meal timing
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meal timingOther

    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.

Study groups in NCT05279014
Study groupRoleWhat they receive
Exercise in a fed-stateActive comparator12-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).
Receives: Other: Meal timing
Exercise in a fasted-stateExperimental12-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.
Receives: Other: Meal timing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Fasting plasma LDL-cholesterol concentrations (mmol/L)

    Measured: Baseline and week 12

Secondary outcomes (21)

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

    Fasting plasma LDL-cholesterol concentrations (mmol/L)

    Measured: Baseline and week 4

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

    Fasting plasma HDL-cholesterol concentrations (mmol/L)

    Measured: Baseline and week 12

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

    Fasting plasma HDL-cholesterol concentrations (mmol/L)

    Measured: Baseline and week 4

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

    Fasting plasma total cholesterol concentrations (mmol/L)

    Measured: Baseline and week 12

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

    Fasting plasma total cholesterol concentrations (mmol/L)

    Measured: Baseline and week 4

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

    Fasting plasma apolipoprotein B concentrations (mmol/L)

    Measured: Baseline and week 12

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

    Fasting plasma apolipoprotein B concentrations (mmol/L)

    Measured: Baseline and week 4

  8. Change in fasting plasma triglyceride concentrations at week 12

    Fasting plasma triglyceride concentrations (mmol/L)

    Measured: Baseline and week 12

  9. Change in fasting plasma triglyceride concentrations at week 4

    Fasting plasma triglyceride concentrations (mmol/L)

    Measured: Baseline and week 4

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 4

  12. Change in fasting plasma glucose concentrations at week 12

    Fasting plasma glucose concentrations (mmol/L)

    Measured: Baseline and week 12

  13. Change in fasting plasma glucose concentrations at week 4

    Fasting plasma glucose concentrations (mmol/L)

    Measured: Baseline and week 4

  14. Change in fasting plasma insulin concentrations at week 12

    Fasting plasma insulin concentrations (mmol/L)

    Measured: Baseline and week 12

  15. Change in fasting plasma insulin concentrations at week 4

    Fasting plasma insulin concentrations (mmol/L)

    Measured: Baseline and week 4

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and week 4

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

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

    Measured: Baseline and week 12

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

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

    Measured: Baseline and Week 12

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

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

    Measured: Baseline and week 12.

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

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

    Measured: Baseline and week 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start30 Mar 2022
  3. Primary completion13 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279014
Sponsor's protocol ID
EIRA1-7137
Status last verified
Mar 2025
First submitted
16 Feb 2022
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 31628477

  • 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.

    PubMed 33428210

Questions about this trial

What is this clinical trial studying?

A study testing Meal timing in people with Cardiovascular Diseases, run by University of Bath at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fasting plasma LDL-C concentrations at week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05279014, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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