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Sedentary; AgingNCT05865639

Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

A study testing Aerobic Exercise and Time Restricted Fasting in people with Sedentary; Aging, run by Guangzhou Sport University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Sedentary; Aging
What is being tested?
Aerobic Exercise and Time Restricted Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteChina
Study dates
1 Feb 2022to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangzhou Sport University

    Guangdong, Guangzhou, 510006

Other trials in China

About this study

Official title: 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.

Being tested
Aerobic Exercise, Time Restricted Fasting
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    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 FastingBehavioural

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

Study groups in NCT05865639
Study groupRoleWhat they receive
Aerobic ExerciseExperimentalAerobic exercise for eight weeks. Three weekly, supervised training sessions.
Receives: Behavioral: Aerobic Exercise
Time Restricted FastingExperimentalTime restricted fasting for eight weeks. Maximal daily eating window of 8 hours.
Receives: Behavioral: Time Restricted Fasting
Aerobic exercise & Time Restricted FastingExperimentalNot described
Receives: Behavioral: Aerobic Exercise; Behavioral: Time Restricted Fasting
ControlNo interventionWill be given information about the recommended level of physical activity for health benefits and a healthy diet.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of cardiovascular risk estimated by heart rate variability

    Measured: From baseline to after 8 weeks intervention

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

    Measured: From baseline to after 8 weeks intervention

  3. Change of cardiovascular risk estimated by pulse wave velocity

    Measured: From baseline to after 8 weeks intervention

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

    Measured: From baseline to after 8 weeks intervention

  5. Change of cardiovascular risk estimated by cytokines level

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

    Measured: From baseline to after 8 weeks intervention

Secondary outcomes (18)

  1. Weight

    In kg

    Measured: From baseline to after 8 weeks intervention

  2. body fat

    In kg

    Measured: From baseline to after 8 weeks intervention

  3. Lean body mass

    In kg

    Measured: From baseline to after 8 weeks intervention

  4. Body mass Index

    In kg/m^2

    Measured: From baseline to after 8 weeks intervention

  5. Body fat percentage

    In percent of total body mass

    Measured: From baseline to after 8 weeks intervention

  6. 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).

    Measured: From baseline to after 8 weeks intervention

  7. 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.

    Measured: From baseline to after 8 weeks intervention

  8. 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.

    Measured: From baseline to after 8 weeks intervention

  9. 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.

    Measured: From baseline to after 8 weeks intervention

  10. 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.

    Measured: From baseline to after 8 weeks intervention

  11. Inflammation level

    Inflammation level were measured by Enzyme-linked immuno sorbent.

    Measured: From baseline to after 8 weeks intervention

  12. Cholesterol in blood

    Total fasting cholesterol in blood

    Measured: From baseline to after 8 weeks intervention

  13. High density lipoprotein in blood

    Fasting high density lipoprotein in blood

    Measured: From baseline to after 8 weeks intervention

  14. Low density lipoprotein in blood

    Fasting low density lipoprotein in blood

    Measured: From baseline to after 8 weeks intervention

  15. Triglycerides in blood

    Fasting triglycerides in blood

    Measured: From baseline to after 8 weeks intervention

  16. Diet in take

    Self-reported: Mint Health application.

    Measured: From baseline to after 8 weeks intervention

  17. Adherence to intervention

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

    Measured: From baseline to after 8 weeks intervention

  18. Adverse reaction

    Self-reported: mini program.

    Measured: From baseline to after 8 weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2023
  2. Study start1 Feb 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865639
Sponsor's protocol ID
20230411
Status last verified
May 2023
First submitted
13 Apr 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peng L, Chen L, Xia J, Zhou J, Shi N, Cheng R, Shu L, Huang J, Hu M, Liao J. The Effects of Time-Restricted Feeding and Exercise on Cardiometabolic Health in Sedentary Older Adults: A Randomized Controlled Trial. Med Sci Sports Exerc. 2026 Jul 1;58(7):1337-1351. doi: 10.1249/MSS.0000000000003962. Epub 2026 Mar 2.

    PubMed 41806970

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise and Time Restricted Fasting in people with Sedentary; Aging, run by Guangzhou Sport University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of cardiovascular risk estimated by heart rate variability (time frame: From baseline to after 8 weeks intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05865639, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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