PreDiabetesNCT05717387
Intermittent Eating on Glucose Homeostasis in Prediabetes
A study testing Time-restricted eating and The 5:2 diet in people with PreDiabetes and Obesity, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. 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 years
- Conditions the study is for
- PreDiabetes, 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
- 87 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2023to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18-75 years;
- Prediabetes;
- 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;
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- 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;
- 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.
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 Intermittent Eating on Glucose Homeostasis in Prediabetes: A Randomized Clinical Trial
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. 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 glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.
Read the detailed description
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. 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 glucose control in type 2 diabetes. No much is known about the effects and molecular mechanisms by TRE or the 5:2 diet improves glucose homeostasis in prediabetes. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care. All eligible participants will participate in an 8-week run-in phase in which they are fed the low-calorie-diet. Participants who pass the run-in phase will be randomly assigned 1:1:1 to one of the three study groups (TRE, the 5:2 diet and control groups). 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
- PreDiabetes, Obesity
- Being tested
- Time-restricted eating, The 5:2 diet
- Keywords
- TRE, The 5:2 diet, Glucose Homeostasis, prediabetes, obesity
- Medical subject headings
- Prediabetic State, Obesity
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 |
|---|---|---|
| Time-restricted eating | 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 | 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 percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.
Measured: Baseline to months 6
Secondary outcomes (21)
Change in mean glucose levels
Measured: Baseline and months 6
Change in glycemic variability
Measured: Baseline and months 6
Change in percent of time below range
<3.9 mmol/L
Measured: Baseline and months 6
Change in percent of time above range
>7.8 mmol/L
Measured: Baseline and months 6
Change in resting metabolic rate
Resting metabolic rate will be assessed by indirect calorimetry.
Measured: Baseline and months 6
Change in gut microbiome composition
Measured: Baseline and months 6
Change in bile acid level
Measured: Baseline and months 6
Change in body weight
Measured: Baseline and months 6
Change in body composition
Body composition will be assessed by DEXA.
Measured: Baseline and months 6
Change in waist circumference
Measured: Baseline and months 6
Change in body mass index
Measured: Baseline and months 6
Change in liver fat
Liver fat will be assessed by liver Fibroscan.
Measured: Baseline and months 6
Change in visceral fat
Visceral fat will be assessed by abdominal CT scan.
Measured: Baseline and months 6
Change in Systolic Blood pressure
Measured: Baseline and months 6
Change in Diastolic Blood pressure
Measured: Baseline and months 6
Change in blood lipids
Measured: Baseline and months 6
Change in HbA1c
Measured: Baseline and months 6
Change in insulin sensitivity
Measured: Baseline and months 6
Change in β cell function
Measured: Baseline and months 6
Change in pulse wave velocity (PWV)
Measured: Baseline and months 6
Change in quality of life
Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)
Measured: Baseline and months 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start11 Apr 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- None (open label)
- Enrolment
- 87 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
- NCT05717387
- Sponsor's protocol ID
- NFEC-2023-017
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Intermittent Eating on Glucose Homeostasis in Prediabetes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05717387
- Acronym / sponsor ID
- NFEC-2023-017
- Conditions
- PreDiabetes, Obesity
- Keywords
- TRE, The 5:2 diet, Glucose Homeostasis, prediabetes, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Feb 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.
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. 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 glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.
Detailed description
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. 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 glucose control in type 2 diabetes. No much is known about the effects and molecular mechanisms by TRE or the 5:2 diet improves glucose homeostasis in prediabetes. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care. All eligible participants will participate in an 8-week run-in phase in which they are fed the low-calorie-diet. Participants who pass the run-in phase will be randomly assigned 1:1:1 to one of the three study groups (TRE, the 5:2 diet and control groups). 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
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | 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 | 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 18-75 years;
- Prediabetes;
- 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 |
|---|---|---|
| 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 | Time-restricted eating |
| 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 |
Primary outcome
Change in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.
Time frame: Baseline to months 6
21 secondary outcomes
Change in mean glucose levels
Time frame: Baseline and months 6
Change in glycemic variability
Time frame: Baseline and months 6
Change in percent of time below range
Time frame: Baseline and months 6
Change in percent of time above range
Time frame: Baseline and months 6
Change in resting metabolic rate
Time frame: Baseline and months 6
Change in gut microbiome composition
Time frame: Baseline and months 6
Change in bile acid level
Time frame: Baseline and months 6
Change in body weight
Time frame: Baseline and months 6
Change in body composition
Time frame: Baseline and months 6
Change in waist circumference
Time frame: Baseline and months 6
Change in body mass index
Time frame: Baseline and months 6
Change in liver fat
Time frame: Baseline and months 6
Change in visceral fat
Time frame: Baseline and months 6
Change in Systolic Blood pressure
Time frame: Baseline and months 6
Change in Diastolic Blood pressure
Time frame: Baseline and months 6
Change in blood lipids
Time frame: Baseline and months 6
Change in HbA1c
Time frame: Baseline and months 6
Change in insulin sensitivity
Time frame: Baseline and months 6
Change in β cell function
Time frame: Baseline and months 6
Change in pulse wave velocity (PWV)
Time frame: Baseline and months 6
Change in quality of life
Time frame: Baseline and months 6
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.
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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 PreDiabetes and 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 3 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 percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring. (time frame: Baseline to months 6). 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.