ClinicalTrials.gg
CompletedNCT03608800Updated May 27, 2020

Potential Effects of Intermittent Fasting to Metabolic Syndrome

An interventional study of Intermittent fasting in Metabolic Syndrome, sponsored by Min Xia. Completed at 1 site in China. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Min Xia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 89 studies in Metabolic Syndrome with a site in China — 35 open to participants now, 39 under way, 1 of them phase 3. Metabolic Syndrome · China.

Enrollment
45th of 50
39 · median 143
Started
2018
with 2 others
No phase
39 of 89
16 open now
Registered
25th of 89
by date

Among the 89 studies in Metabolic Syndrome with a site in China, this one is the 45th largest by enrollment of the 50 interventional ones that give a count, is one of 3 that started in 2018, is one of 39 with no phase, and was the 25th registered.

Metabolic Syndrome

2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

Browse Metabolic Syndrome studies →

Open to participants now

35 of the 89 studies in Metabolic Syndrome with a site in China are open now. Recruiting first, the newest first:

30 more — sign in →

All 35 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 232 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 136 (59%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.

This study: 30 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 89 studies in Metabolic Syndrome with a site in China, or all of them as a file.
02

Study summary

The survey is designed to investigate whether 8 weeks of discrete two-day intermittent fasting per week will impact gut microbiota and cardiovascular risks of metabolic syndrome subjects.

Read the detailed description

Intermittent fasting was demonstrated to optimize energy metabolism and promote health. However, the benefits of intermittent fasting to gut microbiota are remain unclear. Further evidence is needed in understanding the effects of intermittent fasting to gut microbiota and cardiovascular risks in subjects with metabolic syndrome

03

Conditions studied

  • Metabolic Syndrome

Browse trials for

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Local residents aged between 30 to 50 years old
  • Stable body weight (change \<±10% of body weight) for 3 months before the study
  • Central obesity: waist circumference ≥90 cm in males or ≥80 cm in females; plus any two of the following four conditions:

    1. Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L)
    2. Reduced HDL cholesterol: serum HDL-c \<40 mg/dL (1.03 mmol/L) in males or \<50 mg/dL (1.29 mmol/L) in females
    3. Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or receiving medication of hypertension
    4. Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)

Exclusion criteria

Exclusion Criteria:

  • History of cardiovascular and cerebrovascular diseases
  • Acute or chronic infectious diseases within 4 weeks
  • Known malignant tumor
  • Alcohol abuse (weekly consumption of alcohol is more than 70 g in females or 140 g in males)
  • Regular therapy with antihypertensive drug, hypolipidemic agents, hypoglycemic agents, hormonal agents and antidepressants within 6 months
  • Use of probiotics, prebiotics or antibiotics within 3 months and in progress of study
  • Use of antiinflammatory drug in progress of study
  • Following a vegetarian diet or veganism
  • Women who are pregnant or intend to be pregnant during the research
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Intermittent fasting

    two nonconsecutive days of 75% diet energy restriction per week for 8 weeks

    Behavioral: Intermittent fasting

  • No intervention
    Control diet

    maintain the energy intake as usual

Interventions

  • BehavioralIntermittent fasting

    The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks

06

What researchers measure

Primary outcomes

  1. BMI

    BMI(weight in kilograms, height in meters and BMI in kg/m\^2)

    Time frame: 8 weeks

  2. Body fat mass

    Body fat mass (kg)

    Time frame: 8 weeks

Secondary outcomes

  1. systolic pressure

    systolic pressure(mmHg)

    Time frame: 8 weeks

  2. diastolic pressure

    diastolic pressure(mmHg)

    Time frame: 8 weeks

  3. gut microbiota composition

    gut microbiota composition at different levels of classification determined by 16s rRNA pcr

    Time frame: 8 weeks

  4. plasma IL-6

    plasma interleukin 6 (pg/mL)

    Time frame: 8 weeks

  5. plasma TNF-α

    plasma TNF-α (pg/mL)

    Time frame: 8 weeks

  6. plasma sCD40L

    plasma soluble CD40 ligand (ng/mL)

    Time frame: 8 weeks

  7. plasma leptin

    plasma leptin (ng/mL)

    Time frame: 8 weeks

  8. plasma adiponectin

    plasma adiponectin (μg/mL)

    Time frame: 8 weeks

  9. plasma MDA

    plasma malondialdehyde (nmol/mL)

    Time frame: 8 weeks

  10. plasma oxLDL

    plasma oxidative LDL (mU/L)

    Time frame: 8 weeks

  11. plasma total nitrate

    plasma total nitrate (mmol/L)

    Time frame: 8 weeks

  12. plasma AMDA

    plasma asymmetric dimethylarginine (ng/mL)

    Time frame: 8 weeks

  13. plasma VCAM-1

    plasma vascular cell adhesion protein 1 (ng/mL)

    Time frame: 8 weeks

  14. plasma vWF

    plasma Von Willebrand factor (U/mL)

    Time frame: 8 weeks

  15. metabolic pathway of gut microbiota

    metabolic pathway of gut microbiota determined by 16s rRNA pcr

    Time frame: 8 weeks

Other outcomes

  1. serum LDL-cholesterol

    serum LDL-cholesterol(mmol/L);

    Time frame: 8 weeks

  2. serum HDL-cholesterol

    serum HDL-cholesterol (mmol/L);

    Time frame: 8 weeks

  3. serum triglyceride

    serum triglyceride (mmol/L)

    Time frame: 8 weeks

  4. serum Apo B/apo A1

    serum Apo B/apo A1

    Time frame: 8 weeks

  5. serum glucose

    serum glucose (mmol/L)

    Time frame: 8 weeks

  6. serum insulin

    serum insulin (mU/L)

    Time frame: 8 weeks

  7. serum total cholesterol

    serum total cholesterol (mmol/L)

    Time frame: 8 weeks

07

Study locations

1 site
  • Department of Nutrition and Food Hygiene
    Guangzhou, Guangdong 510080, China
08

References and documents

Publications

  • Guo Y, Luo S, Ye Y, Yin S, Fan J, Xia M. Intermittent Fasting Improves Cardiometabolic Risk Factors and Alters Gut Microbiota in Metabolic Syndrome Patients. J Clin Endocrinol Metab. 2021 Jan 1;106(1):64-79. doi: 10.1210/clinem/dgaa644. PubMed 33017844 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in May 2019, 11 months.

Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's 11 months is below that.

Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2018
First posted
Aug 1, 2018
StartActual
Jun 30, 2018
Primary completionActual
May 30, 2019
CompletionActual
May 30, 2019
Last update
May 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03608800
Lead sponsor
Min Xia
Responsible party
Min Xia (professor, Sun Yat-sen University) — Sponsor-investigator
First posted
Aug 1, 2018
Start date
Jun 30, 2018
Primary completion
May 30, 2019
Completion
May 30, 2019
Last update
May 27, 2020

Study contacts

Min Xia, Doctor
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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