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Clinical Trials/NCT05865639
NCT05865639
Completed
Not Applicable

Effects of Time Restricted Fasting and Exercise on Cardiovascular Risks Among Sedentary Adults

Guangzhou Sport University1 site in 1 country56 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedentary; Aging
Sponsor
Guangzhou Sport University
Enrollment
56
Locations
1
Primary Endpoint
Change of cardiovascular risk estimated by ankle-brachial index
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This project will determine the independent and combined effects of aerobic exercise and time restricted fasting on cardiovascular risks among sedentary middle-aged and elderly adults. The online intervention period will be eight weeks. Before and after the intervention, arterial stiffness, cardiac autonomic nervous, body composition, glucolipid metabolism, sleep and eating habits, inflammatory reaction, sedentary behavior and physical activity level will be measured and compared between groups who are doing either aerobic exercise, time restricted fasting, both aerobic exercise and time restricted fasting, or who are in a control group. Adverse reaction, sleep and eating quality, life quality and adherence to the interventions and hunger/satiety will also be measured.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
December 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Guangzhou Sport University
Responsible Party
Principal Investigator
Principal Investigator

Jingwen Liao

Associate Professor

Guangzhou Sport University

Eligibility Criteria

Inclusion Criteria

  • Age: 45-69 years old Sedentary time ≥8 hours per day
  • Irregular exercise habits
  • No drugs affecting the outcome index were taken
  • No history of serious diseases
  • Sign the subject informed consent and agree to participate in this experiment.

Exclusion Criteria

  • The range of body weight change in the last three months is more than 3kg
  • People taking weight-loss drugs
  • Participate in other experimenters 5 months before the experiment
  • Unable to adjust and follow the intervention schedule.

Outcomes

Primary Outcomes

Change of cardiovascular risk estimated by ankle-brachial index

Time Frame: From baseline to after 8 weeks intervention

Change of cardiovascular risk estimated by heart rate variability

Time Frame: From baseline to after 8 weeks intervention

Change of cardiovascular risk estimated by pulse wave velocity

Time Frame: From baseline to after 8 weeks intervention

Change of cardiovascular risk estimated by flow-mediated transition

Time Frame: From baseline to after 8 weeks intervention

Change of cardiovascular risk estimated by cytokines level

Time Frame: From baseline to after 8 weeks intervention

Fasting matrix metalloproteinases, norepinephrine, and neuropeptide Y cytokines level in blood

Secondary Outcomes

  • Sleep quality(From baseline to after 8 weeks intervention)
  • Physical activity(From baseline to after 8 weeks intervention)
  • Weight(From baseline to after 8 weeks intervention)
  • body fat(From baseline to after 8 weeks intervention)
  • Diet habits(From baseline to after 8 weeks intervention)
  • Triglycerides in blood(From baseline to after 8 weeks intervention)
  • Adherence to intervention(From baseline to after 8 weeks intervention)
  • Lean body mass(From baseline to after 8 weeks intervention)
  • Body fat percentage(From baseline to after 8 weeks intervention)
  • Life quality(From baseline to after 8 weeks intervention)
  • Cholesterol in blood(From baseline to after 8 weeks intervention)
  • Diet in take(From baseline to after 8 weeks intervention)
  • Body mass Index(From baseline to after 8 weeks intervention)
  • Low density lipoprotein in blood(From baseline to after 8 weeks intervention)
  • Sedentary activity(From baseline to after 8 weeks intervention)
  • Inflammation level(From baseline to after 8 weeks intervention)
  • High density lipoprotein in blood(From baseline to after 8 weeks intervention)
  • Adverse reaction(From baseline to after 8 weeks intervention)

Study Sites (1)

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