ObesityINTERESTNCT05453617
Intermittent Eating on Sustaining Weight-loss in Obesity
A study testing Time-restricted eating and The 5:2 diet in people with Obesity, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Weight regain after weight loss is a major problem in the treatment of obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Time-restricted eating and The 5:2 diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 15 Jul 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Man or women aged 18-75 years;
- 2.Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Who cannot join
- 1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- 2. Diagnosis of type 1 and type 2 diabetes;
- 3. History of malignant tumors;
- 4. Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- 5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- 6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
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- 7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- 8. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- 9. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- 10. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
- 11. Women who are pregnant or plan to become pregnant;
- 12. Patients who cannot be followed for 24 months (due to a health situation or migration);
- 13. Patients who are unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Huijie Zhang, MD. PhD., +86-020-61641635, Huijiezhang2005@126.com
About this study
Official title: Effects of Intermitting Eating on Weight-Loss Maintenance and Cardiometabolic Risk Factors in Obese Adults: A Randomized Clinical Trial
Weight regain after weight loss is a major problem in the treatment of obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care.
Read the detailed description
Weight regain after weight loss is a major problem in the treatment of persons with obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on weight loss and cardioprotection in humans. Whether TRE or the 5:2 diet is an effective approach for weight-loss maintenance remains unknown. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care. All participants who have achieved greater than 5% of weight loss after a 8-week low-calorie-diet induced weight loss phase, will be assigned to one of the three study groups (TRE, the 5:2 diet and control groups) in a 1:1:1 ratio. Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.
- Conditions
- Obesity
- Being tested
- Time-restricted eating, The 5:2 diet
- Keywords
- Obesity, Time restricted eating, The 5:2 diet, Weight loss maintenance
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm)
The 5:2 dietBehavioural
Participants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
| Study group | Role | What they receive |
|---|---|---|
| The TRE group | Experimental | Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm). Receives: Behavioral: Time-restricted eating |
| The 5:2 diet group | Experimental | Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Receives: Behavioral: The 5:2 diet |
| Control | No intervention | Participants in the control group will receive a general lifestyle counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight over 12 months
Measured: Baseline to months 12
Secondary outcomes (16)
Change in body fat composition meassured by DEXA
Body composition is meassured by dual-energy X-ray absorptiometry scans
Measured: Baseline to months 12
Change in waist circumference
Measured: Baseline to months 12
Change in body mass index
Measured: Baseline to months 12
Change in liver fat
Liver fat is assessed by liver Fibroscan.
Measured: Baseline to months 12
Change in systolic blood pressure
Measured: Baseline to months 12
Change in diastolic blood pressure
Measured: Baseline to months 12
Change in serum triglycerides
Measured: Baseline to months 12
Change in serum total cholesterol
Measured: Baseline to months 12
Change in serum LDL-c
Measured: Baseline to months 12
Change in HbA1c
Measured: Baseline to months 12
Change in insulin sensitivity
Insulin sensitivity is assessed by HOMA-IR
Measured: Baseline to months 12
Change in β cell function
β cell function is assessed by HOMA-B
Measured: Baseline to months 12
Change in arterial stiffness measured by pulse wave velocity
arterial stiffness is measured by pulse wave velocity (PWV)
Measured: Baseline to months 12
Change in depression score measured by the Patient Health Questionnaire-9
Depression is measured by the Patient Health Questionnaire-9 (PHQ-9)
Measured: Baseline to months 12
Change in quality of sleep score measured by the Pittsburgh sleep quality index
Quality of sleep is measured by the Pittsburgh sleep quality index (PSQI)
Measured: Baseline to months 12
Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire
Quality of life is measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Measured: Baseline to months 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Oct 2022
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijie Zhang, Nanfang Hospital, Southern Medical University
- Investigators
- Huijie Zhang, MD. PhD., Principal investigator, Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453617
- Sponsor's protocol ID
- NFEC-2022-155
- Acronym
- INTEREST
- Status last verified
- Nov 2023
- First submitted
- 18 Jun 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermitting Eating on Weight-Loss Maintenance and Cardiometabolic Risk Factors in Obese Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05453617
- Acronym / sponsor ID
- INTEREST / NFEC-2022-155
- Conditions
- Obesity
- Keywords
- Obesity, Time restricted eating, The 5:2 diet, Weight loss maintenance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 12 Jul 2022 (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.
Weight regain after weight loss is a major problem in the treatment of obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care.
Detailed description
Weight regain after weight loss is a major problem in the treatment of persons with obesity. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on weight loss and cardioprotection in humans. Whether TRE or the 5:2 diet is an effective approach for weight-loss maintenance remains unknown. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care. All participants who have achieved greater than 5% of weight loss after a 8-week low-calorie-diet induced weight loss phase, will be assigned to one of the three study groups (TRE, the 5:2 diet and control groups) in a 1:1:1 ratio. Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The TRE group | Experimental | Behavioral: Time-restricted eatingParticipants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm). |
| The 5:2 diet group | Experimental | Behavioral: The 5:2 dietParticipants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. |
| Control | No intervention | –Participants in the control group will receive a general lifestyle counseling. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Man or women aged 18-75 years;
- 2.Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Key exclusion criteria (13 listed)
- 1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- 2. Diagnosis of type 1 and type 2 diabetes;
- 3. History of malignant tumors;
- 4. Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- 5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
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 eatingParticipants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) | Behavioural | The TRE group |
| The 5:2 dietParticipants will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. | Behavioural | The 5:2 diet group |
Primary outcome
Change in body weight over 12 months
Time frame: Baseline to months 12
16 secondary outcomes
Change in body fat composition meassured by DEXA
Time frame: Baseline to months 12
Change in waist circumference
Time frame: Baseline to months 12
Change in body mass index
Time frame: Baseline to months 12
Change in liver fat
Time frame: Baseline to months 12
Change in systolic blood pressure
Time frame: Baseline to months 12
Change in diastolic blood pressure
Time frame: Baseline to months 12
Change in serum triglycerides
Time frame: Baseline to months 12
Change in serum total cholesterol
Time frame: Baseline to months 12
Change in serum LDL-c
Time frame: Baseline to months 12
Change in HbA1c
Time frame: Baseline to months 12
Change in insulin sensitivity
Time frame: Baseline to months 12
Change in β cell function
Time frame: Baseline to months 12
Change in arterial stiffness measured by pulse wave velocity
Time frame: Baseline to months 12
Change in depression score measured by the Patient Health Questionnaire-9
Time frame: Baseline to months 12
Change in quality of sleep score measured by the Pittsburgh sleep quality index
Time frame: Baseline to months 12
Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire
Time frame: Baseline to months 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Huijie Zhang, MD. PhD. principal investigator
Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
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 eating and The 5:2 diet in people with Obesity, run by Nanfang Hospital, Southern Medical 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 2 inclusion and 13 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 9 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huijie Zhang, MD. PhD. (+86-020-61641635, Huijiezhang2005@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight over 12 months (time frame: Baseline to months 12). 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 9 Nov 2023.