Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Sedentary; Aging

Intervention / Treatment
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* Behavioral: Aerobic Exercise
* Behavioral: Time Restricted Fasting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise<br>Aerobic exercise for eight weeks. Three weekly, supervised training sessions. | Behavioral: Aerobic Exercise<br>* Three weekly, supervised exercise sessions with aerobic exercise. Each session will last for 60-65 minutes, each period will be consist of 5 min warm up, 45 min formal training and 5-10 min relaxation training. Intervention period will be eight weeks.<br>|
| Experimental: Time Restricted Fasting<br>Time restricted fasting for eight weeks. Maximal daily eating window of 8 hours. | Behavioral: Time Restricted Fasting<br>* Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.<br>|
| Experimental: Aerobic exercise & Time Restricted Fasting<br> | Behavioral: Aerobic Exercise<br>* Three weekly, supervised exercise sessions with aerobic exercise. Each session will last for 60-65 minutes, each period will be consist of 5 min warm up, 45 min formal training and 5-10 min relaxation training. Intervention period will be eight weeks.<br>Behavioral: Time Restricted Fasting<br>* Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.<br>|
| No Intervention: Control<br>Will be given information about the recommended level of physical activity for health benefits and a healthy diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cardiovascular risk estimated by heart rate variability |  | From baseline to after 8 weeks intervention | 
| Change of cardiovascular risk estimated by ankle-brachial index |  | From baseline to after 8 weeks intervention | 
| Change of cardiovascular risk estimated by pulse wave velocity |  | From baseline to after 8 weeks intervention | 
| Change of cardiovascular risk estimated by flow-mediated transition |  | From baseline to after 8 weeks intervention | 
| Change of cardiovascular risk estimated by cytokines level | Fasting matrix metalloproteinases, norepinephrine, and neuropeptide Y cytokines level in blood | From baseline to after 8 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | In kg | From baseline to after 8 weeks intervention | 
| body fat | In kg | From baseline to after 8 weeks intervention | 
| Lean body mass | In kg | From baseline to after 8 weeks intervention | 
| Body mass Index | In kg/m^2 | From baseline to after 8 weeks intervention | 
| Body fat percentage | In percent of total body mass | From baseline to after 8 weeks intervention | 
| Diet habits | Self-reported: diet habits were assessed using the Adult Eating Behavior Questionnaire (AEBQ). With higher scores indicating worse eating habits (represented by emotional over-eating and emotional under-eating) or better dietary (represented by food responsiveness, enjoyment of food, satiety responsiveness, food fussiness and slowness in eating). | From baseline to after 8 weeks intervention | 
| Sleep quality | Self-reported: sleep quality was indicated by the Pittsburgh Sleep Quality Index (PSQI) Questionnaire. The maximum score of the sleep quality index is 21 points,scores higher than 5 indicate poor sleep quality, with higher scores indicating poorer sleep quality. | From baseline to after 8 weeks intervention | 
| Life quality | Self-reported: life quality was indicated by The World Health Organization Quality of Life (WHOQOL)-BREF Questionnaire. With higher scores indicating better life quality. | From baseline to after 8 weeks intervention | 
| Physical activity | Physical activity were measured by using accelerometer (ActiGraph GT3X+ model, USA).Measured by using accelerometer (ActiGraph GT3X+ model, USA). Accelerometer was used for 7 consecutive days, being affixed to the nondominant wrist. | From baseline to after 8 weeks intervention | 
| Sedentary activity | Sedentary activity were measured by using accelerometer (ActiGraph GT3X+ model, USA).Measured by using accelerometer (ActiGraph GT3X+ model, USA). Accelerometer was used for 7 consecutive days, being affixed to the nondominant wrist. | From baseline to after 8 weeks intervention | 
| Inflammation level | Inflammation level were measured by Enzyme-linked immuno sorbent. | From baseline to after 8 weeks intervention | 
| Cholesterol in blood | Total fasting cholesterol in blood | From baseline to after 8 weeks intervention | 
| High density lipoprotein in blood | Fasting high density lipoprotein in blood | From baseline to after 8 weeks intervention | 
| Low density lipoprotein in blood | Fasting low density lipoprotein in blood | From baseline to after 8 weeks intervention | 
| Triglycerides in blood | Fasting triglycerides in blood | From baseline to after 8 weeks intervention | 
| Diet in take | Self-reported: Mint Health application. | From baseline to after 8 weeks intervention | 
| Adherence to intervention | Self-reported: WeChat application, number of completed exercise sessions out of those prescribed, in percentage. | From baseline to after 8 weeks intervention | 
| Adverse reaction | Self-reported: mini program. | From baseline to after 8 weeks intervention |