Overweight or ObesityNCT06552403
Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China
A study testing A modified 5:2 intermittent fasting diet in people with Overweight or Obesity, run by Zhejiang Provincial Tongde Hospital at 1 site in China.
Trial summary
This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- A modified 5:2 intermittent fasting diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants aged 18 to 60 years
- participants with a body mass index (BMI) ≥ 24 kg/m2
- participants engaged in light physical labor and their weight was relatively stable.
Who cannot join
- participants taking any medication with an effect on body weight in the three months prior to enrollment;
- participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine > the upper limit of normal);
- participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);
- participants with malignant tumors;
- women during pregnancy or breastfeeding;
- participants deemed unsuitable by the investigator to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China: A Self-controlled Clinical Trial
This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.
Read the detailed description
There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.
- Conditions
- Overweight or Obesity
- Being tested
- A modified 5:2 intermittent fasting diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A modified 5:2 intermittent fasting dietDietary supplement
The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day.
| Study group | Role | What they receive |
|---|---|---|
| Modified 5:2 IF diet | Experimental | The modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day. Receives: Dietary Supplement: A modified 5:2 intermittent fasting diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
body measurements
weight, BMI, and waistline
Measured: 24 weeks after intervention
glycolipid metabolism indicators
fasting plasma glucose (FPG), fasting plasma insulin (FPI), fasting C-peptide (FCP), triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and uric acid.
Measured: 24 weeks after intervention
adipokines
leptin and lipocalin
Measured: 24 weeks after intervention
inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention
high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)
Measured: 24 weeks after intervention
Secondary outcomes (1)
Change in metabolic components
Participants' metabolic components were analyzed by serum metabolomics analysis. The ultra-high performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) (Agilent 1290, Agilent Technologies, Inc., USA) was applied to identify metabolites.
Measured: 24 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Tongde Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Wang, Zhejiang Provincial Tongde Hospital
- Investigators
- Xiaoli Wang, Principal investigator, Zhejiang Provincial Tongde Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552403
- Sponsor's protocol ID
- 5:2 intermittent fasting diet
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Gao Q, Xun Y, Wang Y, Mao S. Effects of a modified 5:2 intermittent fasting diet on a population who were overweight or obese in China: a self-controlled clinical trial. Nutr Res Pract. 2026 Feb;20(1):62-76. doi: 10.4162/nrp.2026.20.1.62. Epub 2025 Jul 25.
PubMed 41694464
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China: A Self-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06552403
- Acronym / sponsor ID
- 5:2 intermittent fasting diet
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zhejiang Provincial Tongde HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Aug 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.
This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.
Detailed description
There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified 5:2 IF diet | Experimental | Dietary Supplement: A modified 5:2 intermittent fasting dietThe modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants aged 18 to 60 years
- participants with a body mass index (BMI) ≥ 24 kg/m2
- participants engaged in light physical labor and their weight was relatively stable.
Key exclusion criteria (6 listed)
- participants taking any medication with an effect on body weight in the three months prior to enrollment;
- participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine > the upper limit of normal);
- participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);
- participants with malignant tumors;
- women during pregnancy or breastfeeding;
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 |
|---|---|---|
| A modified 5:2 intermittent fasting dietThe modified 5:2 IF diet involves 2 nonconsecutive fasting days (25%-30% of the total required daily energy intake based on ideal body weight) and 5 days of habitual intake (limited total energy intake according to ideal body weight) per week, as well as a 4-week run-in period and a minimum of 6,000 steps of physical activity per day. | Dietary supplement | Modified 5:2 IF diet |
Primary outcome
body measurements
Time frame: 24 weeks after intervention
weight, BMI, and waistline
glycolipid metabolism indicators
Time frame: 24 weeks after intervention
fasting plasma glucose (FPG), fasting plasma insulin (FPI), fasting C-peptide (FCP), triglycerides (TG), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), and uric acid.
adipokines
Time frame: 24 weeks after intervention
leptin and lipocalin
inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention
Time frame: 24 weeks after intervention
high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6), and tumor necrosis factor-alpha (TNF-α)
1 secondary outcome
Change in metabolic components
Time frame: 24 weeks after intervention
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 14 Aug 2024.
- Derived from this study: PubMed 41694464Wang X, Gao Q, Xun Y, Wang Y, Mao S. Effects of a modified 5:2 intermittent fasting diet on a population who were overweight or obese in China: a self-controlled clinical trial. Nutr Res Pract. 2026 Feb;20(1):62-76. doi: 10.4162/nrp.2026.20.1.62. Epub 2025 Jul 25.
- 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.
Xiaoli Wang principal investigator
Zhejiang Provincial Tongde Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A modified 5:2 intermittent fasting diet in people with Overweight or Obesity, run by Zhejiang Provincial Tongde Hospital 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 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: finished, as of the sponsor's last update on 14 Aug 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 measurements (time frame: 24 weeks after intervention). 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?
On the ClinicalTrials.gov record for NCT06552403, which also lists 1 linked publication.
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 14 Aug 2024.