Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

Sponsor
Guangzhou Sport University (Other)
Overall Status
Completed
CT.gov ID
NCT05865639
Collaborator
Guangdong Provincial Key Laboratory of Physical Activity and Health Promotion (Other), Guangdong Provincial Scientific Research Center (Other)
56
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4
10
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic Exercise
  • Behavioral: Time Restricted Fasting
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of Time Restricted Fasting and Exercise on Cardiovascular Risks Among Sedentary Adults
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Sep 1, 2022
Actual Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change of cardiovascular risk estimated by heart rate variability [From baseline to after 8 weeks intervention]

  2. Change of cardiovascular risk estimated by ankle-brachial index [From baseline to after 8 weeks intervention]

  3. Change of cardiovascular risk estimated by pulse wave velocity [From baseline to after 8 weeks intervention]

  4. Change of cardiovascular risk estimated by flow-mediated transition [From baseline to after 8 weeks intervention]

  5. Change of cardiovascular risk estimated by cytokines level [From baseline to after 8 weeks intervention]

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

Secondary Outcome Measures

  1. Weight [From baseline to after 8 weeks intervention]

    In kg

  2. body fat [From baseline to after 8 weeks intervention]

    In kg

  3. Lean body mass [From baseline to after 8 weeks intervention]

    In kg

  4. Body mass Index [From baseline to after 8 weeks intervention]

    In kg/m^2

  5. Body fat percentage [From baseline to after 8 weeks intervention]

    In percent of total body mass

  6. Diet habits [From baseline to after 8 weeks intervention]

    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).

  7. Sleep quality [From baseline to after 8 weeks intervention]

    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.

  8. Life quality [From baseline to after 8 weeks intervention]

    Self-reported: life quality was indicated by The World Health Organization Quality of Life (WHOQOL)-BREF Questionnaire. With higher scores indicating better life quality.

  9. Physical activity [From baseline to after 8 weeks intervention]

    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.

  10. Sedentary activity [From baseline to after 8 weeks intervention]

    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.

  11. Inflammation level [From baseline to after 8 weeks intervention]

    Inflammation level were measured by Enzyme-linked immuno sorbent.

  12. Cholesterol in blood [From baseline to after 8 weeks intervention]

    Total fasting cholesterol in blood

  13. High density lipoprotein in blood [From baseline to after 8 weeks intervention]

    Fasting high density lipoprotein in blood

  14. Low density lipoprotein in blood [From baseline to after 8 weeks intervention]

    Fasting low density lipoprotein in blood

  15. Triglycerides in blood [From baseline to after 8 weeks intervention]

    Fasting triglycerides in blood

  16. Diet in take [From baseline to after 8 weeks intervention]

    Self-reported: Mint Health application.

  17. Adherence to intervention [From baseline to after 8 weeks intervention]

    Self-reported: WeChat application, number of completed exercise sessions out of those prescribed, in percentage.

  18. Adverse reaction [From baseline to after 8 weeks intervention]

    Self-reported: mini program.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 69 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangzhou Sport University Guangdong Guangzhou China 510006

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jingwen Liao, Associate Professor, Guangzhou Sport University
ClinicalTrials.gov Identifier:
NCT05865639
Other Study ID Numbers:
  • 20230411
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 19, 2023