Healthy PopulationNCT05996042
Time-restricted Diet Combined With Multimodal Aerobic Exercise
A study testing Time-restricted diet in people with Healthy Population, run by Peking University.
Trial summary
Objective: This study aims to compare the effects of a combination of time-restricted diet and multimodal aerobic exercise (calisthenics, yoga, and comprehensive physical training) on cardiovascular and metabolic health in a sedentary population with both interventions alone. Study design. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Population
- What is being tested?
- Time-restricted diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 20 Oct 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the past six months, the average daily sitting time was more than 6 hours, and the average weekly moderate-intensity physical activity time was less than 125 minutes or high-intensity physical activity time was less than 75 minutes as assessed by the International Physical Activity Questionnaire (JAMA Intern Med. 2022 Jun 1; 182(6):650-659, J Sport Health Sci. 2022 Mar; 11(2): 164 -- 171. And Global recommendations on physical activity for health);
- BMI of 18.5-30 kg/m 2, age 18-50, where BMI= weight (kg)/height 2 (m);
- Weight change less than 3 kg in the last six months;
- Unlimited hours or other types of fasting, such as alternate-day fasting or simulated fasting diets;
- No cardiovascular metabolic diseases such as hypertension, type 2 diabetes, chronic kidney disease, coronary heart disease and stroke;
- No movement disorder related diseases, no sports injury history in the past six months.
Who cannot join
- Weigh more than 100 kg;
- Used weight-loss drugs or dietary supplements and used hormone drugs in the past six months;
- Abnormal liver and kidney function was found by laboratory examination;
- Women who are pregnant, lactating or planning to become pregnant in the near future;
- Still unable to skillfully use smart phones and sports bracelets after training;
- Other circumstances deemed unsuitable for participation in the study by the researchers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of Time-restricted Diet Combined With Multimodal Aerobic Exercise Intervention on Cardiovascular and Metabolic Health in a Sedentary Population
Objective: This study aims to compare the effects of a combination of time-restricted diet and multimodal aerobic exercise (calisthenics, yoga, and comprehensive physical training) on cardiovascular and metabolic health in a sedentary population with both interventions alone.
Study design. Randomized controlled trial Participants: Sedentary (average sitting time greater than 6 hours per day over the past six months, and average moderate-intensity physical activity less than 125 minutes per week or vigorous-intensity physical activity less than 75 minutes per week as assessed by the International Physical Activity Questionnaire).
Read more
Sample size: 81 Study grouping and intervention measures: Subjects who signed informed consent and met the inclusion/exclusion conditions were randomly divided into the following three groups according to gender stratification, with 27 participants in each group: single time-limited diet group, single multi-mode aerobic exercise (aerobics, yoga and comprehensive physical training) group, and combination of time-limited diet and multi-mode aerobic exercise group. The subjects who received the time-restricted diet intervention were allowed to eat only from 7am to 3pm on Tuesdays, Thursdays and Saturdays, and were allowed to drink pure water only during the rest of the day. The subjects who received the multi-mode aerobic exercise intervention carried out the exercise intervention from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Medical Department. All subjects did not limit their total daily energy intake. The intervention lasted eight weeks.
Outcome evaluation indicators: The main indicators of this study were body composition (body fat, muscle mass, fat-free weight, body weight, BMI, body fat percentage, total body water, protein, inorganic salts, limb muscle and extracellular water ratio).
Read the detailed description
Subjects who signed the informed consent and met the inclusion criteria were randomly divided into the following three groups according to gender stratification:
- Single time-limited diet group: Subjects in this group were given a time-limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period. Total daily energy intake is not restricted, and food selection is recommended in accordance with the Dietary Guidelines for Chinese Residents (2022). Subjects in this group were required to maintain the original physical activity frequency;
- Independent multi-mode aerobic exercise group: Subjects in this group will do multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Mondays, Wednesdays and Fridays under the unified guidance of the physical education teacher of the Health Science Department (see Attachment 3 for details). The venue is the gymnasium and sports ground of Peking University Health Science Center, and the exercise items include aerobics, yoga and comprehensive physical training, see attachment for details. Subjects in this group do not limit their daily total energy intake, and it is recommended to choose food according to the Dietary Guidelines for Chinese Residents (2022).
- Combined group of time-limited diet and multi-mode aerobic exercise: Subjects in this group received the same time-limited diet intervention according to the above requirements of the single-mode diet group every Tuesday, Thursday and Saturday, and the same multi-mode aerobic exercise intervention according to the above requirements of the single-mode aerobic exercise group every Monday, Wednesday and Friday. Total daily energy intake is not restricted, and food selection is recommended in accordance with the Dietary Guidelines for Chinese Residents (2022).
- Conditions
- Healthy Population
- Being tested
- Time-restricted diet
- Keywords
- Sedentary, Time-restricted diet, Exercise intervention
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted dietBehavioural
Also called Multimodal aerobic exercise
On Tuesdays, Thursdays and Saturdays, only eating is allowed between 7am and 3pm. The rest of the time, only drinking pure water is allowed, which is an eight-hour eating window and a 16-hour fasting period.
On Mondays, Wednesdays and Fridays, under the unified guidance of the physical education teachers of the Health Science Department from 6:00 PM to 7:00 PM, the venue is the gymnasium and sports field of Peking University Health Science Center. The exercise items include aerobics, yoga and comprehensive physical training.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted diet group | Other | Subjects in this group were given a limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period Receives: Behavioral: Time-restricted diet |
| Multimode aerobics group | Other | Subjects in this group performed multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Health Science Center in the gymnasium and sports field of Peking University Health Science Center, including aerobics, yoga and comprehensive physical training Receives: Behavioral: Time-restricted diet |
| A combination of time-restricted diet and multimodal aerobic exercise | Experimental | Subjects in this group received the same time-limited dietary intervention every Tuesday, Thursday and Saturday according to the above requirements of the single time-limited dietary group, and the same multi-mode aerobic exercise intervention every Monday, Wednesday and Friday according to the above requirements of the single multi-mode aerobic exercise group. Receives: Behavioral: Time-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
Measurements were made using the Inbody 770, using the bioresistive method
Measured: Baseline survey
Muscle mass
Measurements were made using the Inbody 770, using the bioresistive method
Measured: Baseline survey
Fat-free weight
Measurements were made using the Inbody 770, using the bioresistive method
Measured: Baseline survey
body weight
Measurements were made using the Inbody 770, using the bioresistive method in Kg
Measured: Baseline survey
body weight
Measurements were made using the Inbody 770, using the bioresistive method in Kg
Measured: 8 weeks after baseline survey
Body fat percentage
Measurements were made using the Inbody 770, using the bioresistive method in %
Measured: Baseline survey
Body fat percentage
Measurements were made using the Inbody 770, using the bioresistive method in %
Measured: 8 weeks after baseline survey
Body water
Measurements were made using the Inbody 770, using the bioresistive method
Measured: Baseline survey
Body water
Measurements were made using the Inbody 770, using the bioresistive method
Measured: 8 weeks after baseline survey
Muscle mass
Measurements were made using the Inbody 770, using the bioresistive method
Measured: 8 weeks after baseline survey
Body fat
Measurements were made using the Inbody 770, using the bioresistive method
Measured: 8 weeks after baseline survey
Fat-free weight
Measurements were made using the Inbody 770, using the bioresistive method
Measured: 8 weeks after baseline survey
Body mass index
Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared
Measured: Baseline survey
Body mass index
Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared
Measured: 8 weeks after baseline survey
Secondary outcomes (14)
Waist circumference
The measurements are made by a professional using a tape measure
Measured: Baseline survey
Waist circumference
The measurements are made by a professional using a tape measure
Measured: 8 weeks after baseline survey
Hip circumference
The measurements are made by a professional using a tape measure
Measured: Baseline survey
Hip circumference
The measurements are made by a professional using a tape measure
Measured: 8 weeks after baseline survey
Blood pressure
The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state
Measured: Baseline survey
Blood pressure
The measurement was carried out using an electronic sphygmomanometer, and the average value was measured three times in the resting state
Measured: 8 weeks after baseline survey
Heart rate
The heart rate band was used for measurement, and the resting state was measured three times to take the average value
Measured: Baseline survey
Heart rate
The heart rate band was used for measurement, and the resting state was measured three times to take the average value
Measured: 8 weeks after baseline survey
Blood Lipid
Fasting blood lipid (TC, TG, HDL-C, LDL-C),Blood is drawn by a trained nurse and blood biochemical tests are performed
Measured: Baseline survey
Blood Lipid
Including TC, TG, HDL-C, LDL-C ,blood is drawn by a trained nurse and blood biochemical tests are performed
Measured: 8 weeks after baseline survey
urine routine
Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital
Measured: Baseline survey
urine routine
Including urinary protein, urinary creatinine, urine collection was followed by routine urine testing at the hospital
Measured: 8 weeks after baseline survey
Questionnaire survey
Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire
Measured: Baseline survey
Questionnaire survey
Demographic characteristics questionnaire, 4-day 24-hour dietary review, international physical activity questionnaire, sleep quality questionnaire, CNAQ appetite questionnaire
Measured: 8 weeks after baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start20 Aug 2023 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qihuang Gong, Dr, Study chair, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996042
- Sponsor's protocol ID
- RCT of Sedentary Population
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymous data is then shared with relevant collaborators
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Time-restricted Diet Combined With Multimodal Aerobic Exercise Intervention on Cardiovascular and Metabolic Health in a Sedentary Population
- ClinicalTrials.gov ID
- NCT05996042
- Acronym / sponsor ID
- RCT of Sedentary Population
- Conditions
- Healthy Population
- Keywords
- Sedentary, Time-restricted diet, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: This study aims to compare the effects of a combination of time-restricted diet and multimodal aerobic exercise (calisthenics, yoga, and comprehensive physical training) on cardiovascular and metabolic health in a sedentary population with both interventions alone.
Study design. Randomized controlled trial Participants: Sedentary (average sitting time greater than 6 hours per day over the past six months, and average moderate-intensity physical activity less than 125 minutes per week or vigorous-intensity physical activity less than 75 minutes per week as assessed by the International Physical Activity Questionnaire).
Sample size: 81 Study grouping and intervention measures: Subjects who signed informed consent and met the inclusion/exclusion conditions were randomly divided into the following three groups according to gender stratification, with 27 participants in each group: single time-limited diet group, single multi-mode aerobic exercise (aerobics, yoga and comprehensive physical training) group, and combination of time-limited diet and multi-mode aerobic exercise group. The subjects who received the time-restricted diet intervention were allowed to eat only from 7am to 3pm on Tuesdays, Thursdays and Saturdays, and were allowed to drink pure water only during the rest of the day. The subjects who received the multi-mode aerobic exercise intervention carried out the exercise intervention from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Medical Department. All subjects did not limit their total daily energy intake. The intervention lasted eight weeks.
Outcome evaluation indicators: The main indicators of this study were body composition (body fat, muscle mass, fat-free weight, body weight, BMI, body fat percentage, total body water, protein, inorganic salts, limb muscle and extracellular water ratio).
Detailed description
Subjects who signed the informed consent and met the inclusion criteria were randomly divided into the following three groups according to gender stratification:
- Single time-limited diet group: Subjects in this group were given a time-limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period. Total daily energy intake is not restricted, and food selection is recommended in accordance with the Dietary Guidelines for Chinese Residents (2022). Subjects in this group were required to maintain the original physical activity frequency;
- Independent multi-mode aerobic exercise group: Subjects in this group will do multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Mondays, Wednesdays and Fridays under the unified guidance of the physical education teacher of the Health Science Department (see Attachment 3 for details). The venue is the gymnasium and sports ground of Peking University Health Science Center, and the exercise items include aerobics, yoga and comprehensive physical training, see attachment for details. Subjects in this group do not limit their daily total energy intake, and it is recommended to choose food according to the Dietary Guidelines for Chinese Residents (2022).
- Combined group of time-limited diet and multi-mode aerobic exercise: Subjects in this group received the same time-limited diet intervention according to the above requirements of the single-mode diet group every Tuesday, Thursday and Saturday, and the same multi-mode aerobic exercise intervention according to the above requirements of the single-mode aerobic exercise group every Monday, Wednesday and Friday. Total daily energy intake is not restricted, and food selection is recommended in accordance with the Dietary Guidelines for Chinese Residents (2022).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time-restricted diet group | Other | Behavioral: Time-restricted dietSubjects in this group were given a limited diet every Tuesday, Thursday and Saturday. They were only allowed to eat from 7am to 3pm on the same day, and only allowed to drink purified water during other periods, namely an 8-hour eating window and a 16-hour fasting period |
| Multimode aerobics group | Other | Behavioral: Time-restricted dietSubjects in this group performed multi-mode aerobic exercise from 6:00 PM to 7:00 PM on Monday, Wednesday and Friday under the unified guidance of the physical education teacher of the Health Science Center in the gymnasium and sports field of Peking University Health Science Center, including aerobics, yoga and comprehensive physical training |
| A combination of time-restricted diet and multimodal aerobic exercise | Experimental | Behavioral: Time-restricted dietSubjects in this group received the same time-limited dietary intervention every Tuesday, Thursday and Saturday according to the above requirements of the single time-limited dietary group, and the same multi-mode aerobic exercise intervention every Monday, Wednesday and Friday according to the above requirements of the single multi-mode aerobic exercise group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In the past six months, the average daily sitting time was more than 6 hours, and the average weekly moderate-intensity physical activity time was less than 125 minutes or high-intensity physical activity time was less than 75 minutes as assessed by the International Physical Activity Questionnaire (JAMA Intern Med. 2022 Jun 1; 182(6):650-659, J Sport Health Sci. 2022 Mar; 11(2): 164 -- 171. And Global recommendations on physical activity for health);
- BMI of 18.5-30 kg/m 2, age 18-50, where BMI= weight (kg)/height 2 (m);
- Weight change less than 3 kg in the last six months;
- Unlimited hours or other types of fasting, such as alternate-day fasting or simulated fasting diets;
- No cardiovascular metabolic diseases such as hypertension, type 2 diabetes, chronic kidney disease, coronary heart disease and stroke;
Key exclusion criteria (6 listed)
- Weigh more than 100 kg;
- Used weight-loss drugs or dietary supplements and used hormone drugs in the past six months;
- Abnormal liver and kidney function was found by laboratory examination;
- Women who are pregnant, lactating or planning to become pregnant in the near future;
- Still unable to skillfully use smart phones and sports bracelets after training;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted dietAlso: Multimodal aerobic exerciseOn Tuesdays, Thursdays and Saturdays, only eating is allowed between 7am and 3pm. The rest of the time, only drinking pure water is allowed, which is an eight-hour eating window and a 16-hour fasting period. On Mondays, Wednesdays and Fridays, under the unified guidance of the physical education teachers of the Health Science Department from 6:00 PM to 7:00 PM, the venue is the gymnasium and sports field of Peking University Health Science Center. The exercise items include aerobics, yoga and comprehensive physical training. | Behavioural | A combination of time-restricted diet and multimodal aerobic exercise, Multimode aerobics group, Time-restricted diet group |
Primary outcome
Body fat
Time frame: Baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Muscle mass
Time frame: Baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Fat-free weight
Time frame: Baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
body weight
Time frame: Baseline survey
Measurements were made using the Inbody 770, using the bioresistive method in Kg
body weight
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, using the bioresistive method in Kg
Body fat percentage
Time frame: Baseline survey
Measurements were made using the Inbody 770, using the bioresistive method in %
Body fat percentage
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, using the bioresistive method in %
Body water
Time frame: Baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Body water
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Muscle mass
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Body fat
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Fat-free weight
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, using the bioresistive method
Body mass index
Time frame: Baseline survey
Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared
Body mass index
Time frame: 8 weeks after baseline survey
Measurements were made using the Inbody 770, measured by weight(Kg) divided by height(meter) squared
14 secondary outcomes
Waist circumference
Time frame: Baseline survey
Waist circumference
Time frame: 8 weeks after baseline survey
Hip circumference
Time frame: Baseline survey
Hip circumference
Time frame: 8 weeks after baseline survey
Blood pressure
Time frame: Baseline survey
Blood pressure
Time frame: 8 weeks after baseline survey
Heart rate
Time frame: Baseline survey
Heart rate
Time frame: 8 weeks after baseline survey
Blood Lipid
Time frame: Baseline survey
Blood Lipid
Time frame: 8 weeks after baseline survey
urine routine
Time frame: Baseline survey
urine routine
Time frame: 8 weeks after baseline survey
Questionnaire survey
Time frame: Baseline survey
Questionnaire survey
Time frame: 8 weeks after baseline survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: Yes. The anonymous data is then shared with relevant collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qihuang Gong, Dr study chair
Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted diet in people with Healthy Population, run by Peking University.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Huang, Dr (13488745828 ext. +86, huangtao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat (time frame: Baseline survey). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2023.