Fasted Exercise and LDL-C

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05279014
• Other study ID #: EIRA1-7137
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• Source: University of Bath
• Contact: Louise Bradshaw
• Phone: 000000
• Email: lb2311[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Department for Health, University of Bath	Bath

Sponsors (3)

Lead Sponsor	Collaborator
University of Bath	King's College London, Zoe Global Limited

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fasting plasma VLDL-rich triglyceride concentrations at week 12	Fasting plasma VLDL-rich triglyceride concentrations (mmol/L)	Baseline and week 12
Other	Change in fasting plasma VLDL-rich triglyceride concentrations at week 4	Fasting plasma VLDL-rich triglyceride concentrations (mmol/L)	Baseline and week 4
Other	Change in body mass at week 12	Body mass (kg)	Baseline and week 12
Other	Change in body mass at week 4	Body mass (kg)	Baseline and week 4
Other	Change in waist-to-hit ratio at week 12	Waist-to-hit ratio	Baseline and week 12
Other	Change in waist-to-hit ratio at week 4	Waist-to-hit ratio	Baseline and week 4
Other	Change in fat mass at week 12	Fat mass determined by dual-energy x-ray absorptiometry (kg)	Baseline and week 12
Other	Change in fat mass at week 4	Fat mass determined by dual-energy x-ray absorptiometry (kg)	Baseline and week 4
Other	Change in fat-free mass at week 12	Fat-free mass determined by dual-energy x-ray absorptiometry (kg)	Baseline and week 12
Other	Change in fat-free mass at week 4	Fat-free mass determined by dual-energy x-ray absorptiometry (kg)	Baseline and week 4
Other	Change in sagittal abdominal diameter at week 12	Sagittal abdominal diameter (cm)	Baseline and week 12
Other	Change in sagittal abdominal diameter at week 4	Sagittal abdominal diameter (cm)	Baseline and week 4
Other	Change in gut microbiome species richness at week 12	Species count in fecal sample (as part of ZOE testing program)	Baseline and week 12
Primary	Change in fasting plasma LDL-C concentrations at week 12	Fasting plasma LDL-cholesterol concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma LDL-C concentrations at week 4	Fasting plasma LDL-cholesterol concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma HDL-C concentrations at week 12	Fasting plasma HDL-cholesterol concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma HDL-C concentrations at week 4	Fasting plasma HDL-cholesterol concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma total cholesterol concentrations at week 12	Fasting plasma total cholesterol concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma total cholesterol concentrations at week 4	Fasting plasma total cholesterol concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma apolipoprotein B concentrations at week 12	Fasting plasma apolipoprotein B concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma apolipoprotein B concentrations at week 4	Fasting plasma apolipoprotein B concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma triglyceride concentrations at week 12	Fasting plasma triglyceride concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma triglyceride concentrations at week 4	Fasting plasma triglyceride concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma C-reactive protein concentrations at week 12	Fasting plasma C-reactive protein concentrations (mg/L)	Baseline and week 12
Secondary	Change in fasting plasma C-reactive protein concentrations at week 4	Fasting plasma C-reactive protein concentrations (mg/L)	Baseline and week 4
Secondary	Change in fasting plasma glucose concentrations at week 12	Fasting plasma glucose concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma glucose concentrations at week 4	Fasting plasma glucose concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma insulin concentrations at week 12	Fasting plasma insulin concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma insulin concentrations at week 4	Fasting plasma insulin concentrations (mmol/L)	Baseline and week 4
Secondary	Change in fasting plasma non-esterified fatty acid concentrations at week 12	Fasting plasma non-esterified fatty acid concentrations (mmol/L)	Baseline and week 12
Secondary	Change in fasting plasma non-esterified fatty acid concentrations at week 4	Fasting plasma non-esterified fatty acid concentrations (mmol/L)	Baseline and week 4
Secondary	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	Baseline and week 12
Secondary	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	Baseline and Week 12
Secondary	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	Baseline and week 12.
Secondary	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	Baseline and week 12.