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Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05865639
Enrollment
56
Registered
2023-05-19
Start date
2022-02-01
Completion date
2022-12-01
Last updated
2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedentary; Aging

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.

Interventions

BEHAVIORALAerobic 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.

BEHAVIORALTime Restricted Fasting

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 69 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Change of cardiovascular risk estimated by heart rate variabilityFrom baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by ankle-brachial indexFrom baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by pulse wave velocityFrom baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by flow-mediated transitionFrom baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by cytokines levelFrom baseline to after 8 weeks interventionFasting matrix metalloproteinases, norepinephrine, and neuropeptide Y cytokines level in blood

Secondary

MeasureTime frameDescription
Diet habitsFrom baseline to after 8 weeks interventionSelf-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).
Sleep qualityFrom baseline to after 8 weeks interventionSelf-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.
Life qualityFrom baseline to after 8 weeks interventionSelf-reported: life quality was indicated by The World Health Organization Quality of Life (WHOQOL)-BREF Questionnaire. With higher scores indicating better life quality.
Physical activityFrom baseline to after 8 weeks interventionPhysical 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.
Sedentary activityFrom baseline to after 8 weeks interventionSedentary 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.
Inflammation levelFrom baseline to after 8 weeks interventionInflammation level were measured by Enzyme-linked immuno sorbent.
WeightFrom baseline to after 8 weeks interventionIn kg
High density lipoprotein in bloodFrom baseline to after 8 weeks interventionFasting high density lipoprotein in blood
Low density lipoprotein in bloodFrom baseline to after 8 weeks interventionFasting low density lipoprotein in blood
Triglycerides in bloodFrom baseline to after 8 weeks interventionFasting triglycerides in blood
Diet in takeFrom baseline to after 8 weeks interventionSelf-reported: Mint Health application.
Adherence to interventionFrom baseline to after 8 weeks interventionSelf-reported: WeChat application, number of completed exercise sessions out of those prescribed, in percentage.
Adverse reactionFrom baseline to after 8 weeks interventionSelf-reported: mini program.
Cholesterol in bloodFrom baseline to after 8 weeks interventionTotal fasting cholesterol in blood
body fatFrom baseline to after 8 weeks interventionIn kg
Lean body massFrom baseline to after 8 weeks interventionIn kg
Body mass IndexFrom baseline to after 8 weeks interventionIn kg/m\^2
Body fat percentageFrom baseline to after 8 weeks interventionIn percent of total body mass

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026