Clinical trial NCT05865639: Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults
Official title: Effects of Time Restricted Fasting and Exercise on Cardiovascular Risks Among Sedentary Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary; Aging
Lead sponsor: Guangzhou Sport University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Key Laboratory of Physical Activity and Health Promotion
name: Guangdong Provincial Scientific Research Center
First posted: 2023-05-19
Enrollment: 56
Sex: ALL
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change of cardiovascular risk estimated by heart rate variability
timeFrame: From baseline to after 8 weeks intervention
measure: Change of cardiovascular risk estimated by ankle-brachial index
timeFrame: From baseline to after 8 weeks intervention
measure: Change of cardiovascular risk estimated by pulse wave velocity
timeFrame: From baseline to after 8 weeks intervention
measure: Change of cardiovascular risk estimated by flow-mediated transition
timeFrame: From baseline to after 8 weeks intervention
measure: Change of cardiovascular risk estimated by cytokines level
timeFrame: From baseline to after 8 weeks intervention
Secondary outcomes:
measure: Weight
timeFrame: From baseline to after 8 weeks intervention
measure: body fat
timeFrame: From baseline to after 8 weeks intervention
measure: Lean body mass
timeFrame: From baseline to after 8 weeks intervention
measure: Body mass Index
timeFrame: From baseline to after 8 weeks intervention
measure: Body fat percentage
timeFrame: From baseline to after 8 weeks intervention
measure: Diet habits
timeFrame: From baseline to after 8 weeks intervention
measure: Sleep quality
timeFrame: From baseline to after 8 weeks intervention
measure: Life quality
timeFrame: From baseline to after 8 weeks intervention
measure: Physical activity
timeFrame: From baseline to after 8 weeks intervention
measure: Sedentary activity
timeFrame: From baseline to after 8 weeks intervention
measure: Inflammation level
timeFrame: From baseline to after 8 weeks intervention
measure: Cholesterol in blood
timeFrame: From baseline to after 8 weeks intervention
measure: High density lipoprotein in blood
timeFrame: From baseline to after 8 weeks intervention
measure: Low density lipoprotein in blood
timeFrame: From baseline to after 8 weeks intervention
measure: Triglycerides in blood
timeFrame: From baseline to after 8 weeks intervention
measure: Diet in take
timeFrame: From baseline to after 8 weeks intervention
measure: Adherence to intervention
timeFrame: From baseline to after 8 weeks intervention
measure: Adverse reaction
timeFrame: From baseline to after 8 weeks intervention
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Guangzhou Sport University
state: Guangzhou
Study officials:
References: