Time Restricted FeedingNCT06420466
Time-Restricted Feeding on Cardiovascular Health Effects
A study testing Time-restricted Feeding in people with Time Restricted Feeding and Cardiovascular Health, run by Zhengqi Qiu at 1 site in China.
Trial summary
Study Design and Participants This intervention study was conducted as a randomized controlled trial (RCT) aimed at investigating the effects of time-restricted feeding (TRF) on cardiovascular health markers among overweight male university students in Shenzhen, China. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men only
- Conditions the study is for
- Time Restricted Feeding, Cardiovascular Health, Body Composition
- What is being tested?
- Time-restricted Feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 May 2024
- 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 24 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects were able to provide signed and dated written informed consent.
- Subjects are male undergraduates aged 18-24 years old.
- BMI between 24 and 28.
- Normal sleep duration, usually between 7-9 hours per day.
- Stable sleep habits, typically going to bed around midnight (±1 hour).
Who cannot join
- Inability to comply with the time-limited diet plan.
- Experiencing hypoglycemic reactions during the time-limited diet program.
- Presence of metabolic diseases such as diabetes.
- Participation in high-intensity physical training for more than 5 hours per week.
- Extreme chronotypes, as indicated by scores ≤30 or ≥70 on the Morning and Evening Questionnaire Self-Assessment Scales (MEQ-SA).
- Severe weight instability, defined as weight gain or loss of more than 5 kg in the 3 months prior to the study.
- Severe food allergy or intolerance.
- Participation in another medical study within 6 months prior to the first study visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Intake Status and Time-Restricted Feeding on Cardiovascular Health Effects in the Overweight Population: A Study of Students at a Shenzhen University
Study Design and Participants This intervention study was conducted as a randomized controlled trial (RCT) aimed at investigating the effects of time-restricted feeding (TRF) on cardiovascular health markers among overweight male university students in Shenzhen, China. The study recruited male university students aged between 18 and 24 years, with a Body Mass Index (BMI) ranging from 24 to less than 28. All participants were free from severe psychiatric illnesses, metabolic syndrome, diabetes, alcoholic fatty liver disease, hyperthyroidism, or hypothyroidism. Inclusion criteria required participants to be non-smokers, not currently on any diet pills, and have no history of cardiovascular or metabolic diseases.
Randomization and Intervention Fifty eligible participants were randomly assigned to either the intervention group (n=25) or the control group (n=25). The intervention group underwent a 6-hour daily TRF from noon to 6 P.M., while the control group did not participate in TRF but maintained their usual eating patterns. No restrictions were placed on the type or quantity of food consumed by participants in either group.
Read more
Data Collection and Measures Body Composition and Anthropometry: Measurements included body mass index, body fat percentage, muscle mass, hydration levels, protein content, and visceral fat, all assessed using a bioelectrical impedance analysis scale (Mi Body Composition Scale 2 by Huami Technology). Waist circumference was manually measured by experienced nurses using a tape measure.
Blood Pressure and Heart Rate: These vital signs were monitored using an arm cuff electronic blood pressure monitor (Panasonic EW3153), with the arm positioned at heart level to ensure accuracy. Measurements were taken after at least five minutes of seated rest.
Nutritional Intake Although time-restricted feeding interventions do not usually change the content or quantity of dietary intake, the total daily intakes of energy, fat, protein, carbohydrate, cholesterol, and fibre were calculated using the Nutritionist Pro food analysis program. This was used to determine possible changes in the subjects' dietary composition as a result of the intervention.
Compliance and Ethical Considerations The study protocol was approved by the Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen), with the approval number KY-2022-101-01. All data were handled confidentially, and measures were taken to ensure high adherence and minimal loss to follow-up.
Statistical Analysis Descriptive statistics such as range, mean, standard deviation, and percentages were used to describe the sample characteristics. To compare differences, the change from baseline levels was assessed to account for initial variability, employing an independent samples t-test for the analysis.
- Conditions
- Time Restricted Feeding, Cardiovascular Health, Body Composition, Blood Pressure, Young Adult
- Being tested
- Time-restricted Feeding
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted FeedingBehavioural
Controlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted Feeding group | Experimental | Controlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake. Receives: Behavioral: Time-restricted Feeding |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
BMI is calculated using a standardized ratio of weight to height (kg/m²), offering a quantitative measure of body composition. This outcome will be assessed using digital scales for accurate weight measurement and stadiometers for height, ensuring precise BMI calculation.
Measured: 4 Weeks
Waist Circumference
Waist circumference is measured using a flexible measuring tape, which allows for a direct quantification of visceral fat accumulation. This measure provides critical insights into metabolic health risks, differentiating it from BMI by focusing specifically on central obesity.
Measured: 4 Weeks
Blood pressure
Revised Description: Blood pressure will be measured using a standardized sphygmomanometer, ensuring consistent and reproducible results. This tool will help monitor changes in systolic and diastolic blood pressure, which are vital for evaluating the effects of time-restricted eating on cardiovascular health.
Measured: 4 Weeks
Nutritional indicators
Nutritional indicators will be assessed through detailed 24-hour dietary recall interviews and food diaries analyzed using nutritional analysis software. This approach will quantify changes in nutrient intake, highlighting the dietary impact of time-restricted feeding interventions.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Feb 2024
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Restricted FeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengqi Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen University
- Responsible party
- Sponsor-investigator, Zhengqi Qiu, Macau University of Science and Technology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420466
- Sponsor's protocol ID
- KY-2022-101-01
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No external funding was received for this study and there are no plans to make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake Status and Time-Restricted Feeding on Cardiovascular Health Effects in the Overweight Population: A Study of Students at a Shenzhen University
- ClinicalTrials.gov ID
- NCT06420466
- Acronym / sponsor ID
- KY-2022-101-01
- Conditions
- Time Restricted Feeding, Cardiovascular Health, Body Composition, Blood Pressure, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zhengqi QiuUniversity, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 May 2024 (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.
Study Design and Participants This intervention study was conducted as a randomized controlled trial (RCT) aimed at investigating the effects of time-restricted feeding (TRF) on cardiovascular health markers among overweight male university students in Shenzhen, China. The study recruited male university students aged between 18 and 24 years, with a Body Mass Index (BMI) ranging from 24 to less than 28. All participants were free from severe psychiatric illnesses, metabolic syndrome, diabetes, alcoholic fatty liver disease, hyperthyroidism, or hypothyroidism. Inclusion criteria required participants to be non-smokers, not currently on any diet pills, and have no history of cardiovascular or metabolic diseases.
Randomization and Intervention Fifty eligible participants were randomly assigned to either the intervention group (n=25) or the control group (n=25). The intervention group underwent a 6-hour daily TRF from noon to 6 P.M., while the control group did not participate in TRF but maintained their usual eating patterns. No restrictions were placed on the type or quantity of food consumed by participants in either group.
Data Collection and Measures Body Composition and Anthropometry: Measurements included body mass index, body fat percentage, muscle mass, hydration levels, protein content, and visceral fat, all assessed using a bioelectrical impedance analysis scale (Mi Body Composition Scale 2 by Huami Technology). Waist circumference was manually measured by experienced nurses using a tape measure.
Blood Pressure and Heart Rate: These vital signs were monitored using an arm cuff electronic blood pressure monitor (Panasonic EW3153), with the arm positioned at heart level to ensure accuracy. Measurements were taken after at least five minutes of seated rest.
Nutritional Intake Although time-restricted feeding interventions do not usually change the content or quantity of dietary intake, the total daily intakes of energy, fat, protein, carbohydrate, cholesterol, and fibre were calculated using the Nutritionist Pro food analysis program. This was used to determine possible changes in the subjects' dietary composition as a result of the intervention.
Compliance and Ethical Considerations The study protocol was approved by the Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen), with the approval number KY-2022-101-01. All data were handled confidentially, and measures were taken to ensure high adherence and minimal loss to follow-up.
Statistical Analysis Descriptive statistics such as range, mean, standard deviation, and percentages were used to describe the sample characteristics. To compare differences, the change from baseline levels was assessed to account for initial variability, employing an independent samples t-test for the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Time-restricted Feeding group | Experimental | Behavioral: Time-restricted FeedingControlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects were able to provide signed and dated written informed consent.
- Subjects are male undergraduates aged 18-24 years old.
- BMI between 24 and 28.
- Normal sleep duration, usually between 7-9 hours per day.
- Stable sleep habits, typically going to bed around midnight (±1 hour).
Key exclusion criteria (8 listed)
- Inability to comply with the time-limited diet plan.
- Experiencing hypoglycemic reactions during the time-limited diet program.
- Presence of metabolic diseases such as diabetes.
- Participation in high-intensity physical training for more than 5 hours per week.
- Extreme chronotypes, as indicated by scores ≤30 or ≥70 on the Morning and Evening Questionnaire Self-Assessment Scales (MEQ-SA).
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 FeedingControlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake. | Behavioural | Time-restricted Feeding group |
Primary outcome
Body Mass Index (BMI)
Time frame: 4 Weeks
BMI is calculated using a standardized ratio of weight to height (kg/m²), offering a quantitative measure of body composition. This outcome will be assessed using digital scales for accurate weight measurement and stadiometers for height, ensuring precise BMI calculation.
Waist Circumference
Time frame: 4 Weeks
Waist circumference is measured using a flexible measuring tape, which allows for a direct quantification of visceral fat accumulation. This measure provides critical insights into metabolic health risks, differentiating it from BMI by focusing specifically on central obesity.
Blood pressure
Time frame: 4 Weeks
Revised Description: Blood pressure will be measured using a standardized sphygmomanometer, ensuring consistent and reproducible results. This tool will help monitor changes in systolic and diastolic blood pressure, which are vital for evaluating the effects of time-restricted eating on cardiovascular health.
Nutritional indicators
Time frame: 4 Weeks
Nutritional indicators will be assessed through detailed 24-hour dietary recall interviews and food diaries analyzed using nutritional analysis software. This approach will quantify changes in nutrient intake, highlighting the dietary impact of time-restricted feeding interventions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No. No external funding was received for this study and there are no plans to make individual participant data available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted Feeding in people with Time Restricted Feeding and Cardiovascular Health, run by Zhengqi Qiu 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 8 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 20 May 2024. 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?
Body Mass Index (BMI) (time frame: 4 Weeks). The study lists 4 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 20 May 2024.