Time Restricted Fasting and Aerobic Exercise Interventions Among Sedentary Adults

May 9, 2023 updated by: Jingwen Liao, Guangzhou Sport University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of cardiovascular risk estimated by heart rate variability
Time Frame: From baseline to after 8 weeks intervention
From baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by ankle-brachial index
Time Frame: From baseline to after 8 weeks intervention
From baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by pulse wave velocity
Time Frame: From baseline to after 8 weeks intervention
From baseline to after 8 weeks intervention
Change of cardiovascular risk estimated by flow-mediated transition
Time Frame: From baseline to after 8 weeks intervention
From baseline to after 8 weeks intervention
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
From baseline to after 8 weeks intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: From baseline to after 8 weeks intervention
In kg
From baseline to after 8 weeks intervention
body fat
Time Frame: From baseline to after 8 weeks intervention
In kg
From baseline to after 8 weeks intervention
Lean body mass
Time Frame: From baseline to after 8 weeks intervention
In kg
From baseline to after 8 weeks intervention
Body mass Index
Time Frame: From baseline to after 8 weeks intervention
In kg/m^2
From baseline to after 8 weeks intervention
Body fat percentage
Time Frame: From baseline to after 8 weeks intervention
In percent of total body mass
From baseline to after 8 weeks intervention
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).
From baseline to after 8 weeks intervention
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.
From baseline to after 8 weeks intervention
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.
From baseline to after 8 weeks intervention
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.
From baseline to after 8 weeks intervention
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.
From baseline to after 8 weeks intervention
Inflammation level
Time Frame: From baseline to after 8 weeks intervention
Inflammation level were measured by Enzyme-linked immuno sorbent.
From baseline to after 8 weeks intervention
Cholesterol in blood
Time Frame: From baseline to after 8 weeks intervention
Total fasting cholesterol in blood
From baseline to after 8 weeks intervention
High density lipoprotein in blood
Time Frame: From baseline to after 8 weeks intervention
Fasting high density lipoprotein in blood
From baseline to after 8 weeks intervention
Low density lipoprotein in blood
Time Frame: From baseline to after 8 weeks intervention
Fasting low density lipoprotein in blood
From baseline to after 8 weeks intervention
Triglycerides in blood
Time Frame: From baseline to after 8 weeks intervention
Fasting triglycerides in blood
From baseline to after 8 weeks intervention
Diet in take
Time Frame: From baseline to after 8 weeks intervention
Self-reported: Mint Health application.
From baseline to after 8 weeks intervention
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.
From baseline to after 8 weeks intervention
Adverse reaction
Time Frame: From baseline to after 8 weeks intervention
Self-reported: mini program.
From baseline to after 8 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Sport University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Provincial Key Laboratory of Physical Activity and Health Promotion
Guangdong Provincial Scientific Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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