Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Sedentary; Aging
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: Time Restricted Fasting

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangdong, Guangzhou, China, 510006
      • Guangzhou Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic Exercise; Aerobic exercise for eight weeks. Three weekly, supervised training sessions.	Behavioral: Aerobic Exercise; 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.
Experimental: Time Restricted Fasting; Time restricted fasting for eight weeks. Maximal daily eating window of 8 hours.	Behavioral: Time Restricted Fasting; Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.
Experimental: Aerobic exercise & Time Restricted Fasting	Behavioral: Aerobic Exercise; 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.; Behavioral: Time Restricted Fasting; Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.
No Intervention: Control; Will be given information about the recommended level of physical activity for health benefits and a healthy diet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Sport University
• Collaborators: Guangdong Provincial Key Laboratory of Physical Activity and Health Promotion; Guangdong Provincial Scientific Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20230411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No