ObesityINTEREST-3NCT06302803
Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)
A study testing Intermittent fasting plus time-restricted eating and Calorie restriction in people with Obesity, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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?
- Intermittent fasting plus time-restricted eating and Calorie restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Man or women aged 18-75 years;
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Who cannot join
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 and type 2 diabetes;
- History of malignant tumors;
- 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);
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
Show all 13Show fewer
- History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- 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;
- Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
- Women who are pregnant or plan to become pregnant;
- Patients who cannot be followed for 24 months (due to a health situation or migration);
- Patients who are unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Huijie Zhang, MD,PhD
About this study
Official title: Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
Read the detailed description
Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
- Conditions
- Obesity
- Being tested
- Intermittent fasting plus time-restricted eating, Calorie restriction
- Keywords
- Obesity, Time restricted eating, Intermittent Fasting, Modified Intermittent Eating strategy, Calorie restriction, Weight loss
- Medical subject headings
- Obesity, Intermittent Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fasting plus time-restricted eatingBehavioural
Also called mTRE
Participants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week.
Calorie restrictionBehavioural
Also called CR
Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time.
| Study group | Role | What they receive |
|---|---|---|
| The mTRE group | Experimental | Participants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week. Receives: Behavioral: Intermittent fasting plus time-restricted eating |
| The CR group | Experimental | Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time. Receives: Behavioral: Calorie restriction |
| Control | No intervention | usual health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight over 12 months
Change in body weight over 12 months
Measured: Baseline to months 12
Secondary outcomes (16)
Change in body mass index （BMI）
body mass index : the weight in kilograms divided by the square of the height in meters.The higher scores mean a worse outcome.
Measured: Baseline to months 12
Change in waist circumference
Wrap a tape measure around the waist at the level of the navel.
Measured: Baseline to months 12
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 liver fat
Liver fat is assessed by liver Fibroscan
Measured: Baseline to months 12
Change in systolic blood pressure
blood pressure
Measured: Baseline to months 12
Change in diastolic blood pressure
blood pressure
Measured: Baseline to months 12
Change in concentration of serum triglyceride
the contents of serum triglyceride
Measured: Baseline to months 12
Change in concentration of serum total cholesterol
the contents of serum total cholesterol
Measured: Baseline to months 12
Change in concentration of serum LDL-c
the contents of Low Density Lipoprotein
Measured: Baseline to months 12
Change in concentration of HbA1c
the contents of Glycated hemoglobin
Measured: Baseline to months 12
Change in insulin sensitivity
Insulin sensitivity is assessed by HOMA-IR (Homeostatic Model Assessment for Insulin Resistance).
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). The maximum value is 27, and the minimum value is 0 . The higher scores mean a worse outcome.
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). The maximum value is 21, and the minimum value is 0 . The higher scores mean a worse outcome.
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). The maximum value is 100, and the minimum value is 0 . The higher scores mean a better outcome.
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 Mar 2024
- Study start7 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huijie Zhang, MD. PhD., Principal investigator, Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302803
- Sponsor's protocol ID
- NFEC-2024-033
- Acronym
- INTEREST-3
- Status last verified
- Jun 2024
- First submitted
- 4 Mar 2024
- Last updated
- 24 Jun 2024
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06302803
- Acronym / sponsor ID
- INTEREST-3 / NFEC-2024-033
- Conditions
- Obesity
- Keywords
- Obesity, Time restricted eating, Intermittent Fasting, Modified Intermittent Eating strategy, Calorie restriction, Weight loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Mar 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.
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
Detailed description
Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained 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 days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The mTRE group | Experimental | Behavioral: Intermittent fasting plus time-restricted eatingParticipants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week. |
| The CR group | Experimental | Behavioral: Calorie restrictionParticipants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time. |
| Control | No intervention | –usual health care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Man or women aged 18-75 years;
- Body mass index (BMI)of 28.0 to 45.0 kg/m2;
Key exclusion criteria (13 listed)
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 and type 2 diabetes;
- History of malignant tumors;
- 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);
- 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 |
|---|---|---|
| Intermittent fasting plus time-restricted eatingAlso: mTREParticipants in the mTRE group will be instructed to eat during a window of 8 h (8 am to 4 pm) 5 days and fast (approximately 500-600 kcal per day) 2 days per week. | Behavioural | The mTRE group |
| Calorie restrictionAlso: CRParticipants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on eating time. | Behavioural | The CR group |
Primary outcome
Change in body weight over 12 months
Time frame: Baseline to months 12
Change in body weight over 12 months
16 secondary outcomes
Change in body mass index （BMI）
Time frame: Baseline to months 12
Change in waist circumference
Time frame: Baseline to months 12
Change in body fat composition meassured by DEXA
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 concentration of serum triglyceride
Time frame: Baseline to months 12
Change in concentration of serum total cholesterol
Time frame: Baseline to months 12
Change in concentration of serum LDL-c
Time frame: Baseline to months 12
Change in concentration of 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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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.
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 Intermittent fasting plus time-restricted eating and Calorie restriction 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: looking for participants now, as of the sponsor's last update on 24 Jun 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?
This study is still under way. Results are not available in the source record yet.
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 24 Jun 2024.