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Completed

NCT Number: NCT05865639

Time Restricted Fasting and Aerobic Exercise Interventions 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.

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Key information

Conditions

Sedentary; Aging Behavior Sedentary Behavior

Age range

45 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Sport University

Guangdong, Guangzhou, 510006, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic Exercise

Behavioral

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.

Time Restricted Fasting

Behavioral

Restricted daily window of caloric intake to maximum 8 hours. Intervention period will be eight weeks.

Primary outcomes

  1. Change of cardiovascular risk estimated by heart rate variability

    Time frame: From baseline to after 8 weeks intervention

  2. Change of cardiovascular risk estimated by ankle-brachial index

    Time frame: From baseline to after 8 weeks intervention

  3. Change of cardiovascular risk estimated by pulse wave velocity

    Time frame: From baseline to after 8 weeks intervention

  4. Change of cardiovascular risk estimated by flow-mediated transition

    Time frame: From baseline to after 8 weeks intervention

  5. 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

  1. Weight

    Time frame: From baseline to after 8 weeks intervention

    In kg

  2. body fat

    Time frame: From baseline to after 8 weeks intervention

    In kg

  3. Lean body mass

    Time frame: From baseline to after 8 weeks intervention

    In kg

  4. Body mass Index

    Time frame: From baseline to after 8 weeks intervention

    In kg/m^2

  5. Body fat percentage

    Time frame: From baseline to after 8 weeks intervention

    In percent of total body mass

  6. Diet habits

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From baseline to after 8 weeks intervention

    Inflammation level were measured by Enzyme-linked immuno sorbent.

  12. Cholesterol in blood

    Time frame: From baseline to after 8 weeks intervention

    Total fasting cholesterol in blood

  13. High density lipoprotein in blood

    Time frame: From baseline to after 8 weeks intervention

    Fasting high density lipoprotein in blood

  14. Low density lipoprotein in blood

    Time frame: From baseline to after 8 weeks intervention

    Fasting low density lipoprotein in blood

  15. Triglycerides in blood

    Time frame: From baseline to after 8 weeks intervention

    Fasting triglycerides in blood

  16. Diet in take

    Time frame: From baseline to after 8 weeks intervention

    Self-reported: Mint Health application.

  17. Adherence to intervention

    Time frame: 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

    Time frame: From baseline to after 8 weeks intervention

    Self-reported: mini program.

Sponsors and collaborators

Lead sponsor

Guangzhou Sport University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 19, 2023
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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