NCT03608800

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

July 22, 2018

Last Update Submit

May 24, 2020

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • BMI

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

    8 weeks

  • Body fat mass

    Body fat mass (kg)

    8 weeks

Secondary Outcomes (15)

  • systolic pressure

    8 weeks

  • diastolic pressure

    8 weeks

  • gut microbiota composition

    8 weeks

  • plasma IL-6

    8 weeks

  • plasma TNF-α

    8 weeks

  • +10 more secondary outcomes

Other Outcomes (7)

  • serum LDL-cholesterol

    8 weeks

  • serum HDL-cholesterol

    8 weeks

  • serum triglyceride

    8 weeks

  • +4 more other outcomes

Study Arms (2)

Intermittent fasting

EXPERIMENTAL

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

Behavioral: Intermittent fasting

Control diet

NO INTERVENTION

maintain the energy intake as usual

Interventions

Intermittent fastingBEHAVIORAL

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

Intermittent fasting

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L)
  • 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
  • Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or receiving medication of hypertension
  • Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • 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.

    PMID: 33017844DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Min Xia, Doctor

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 22, 2018

First Posted

August 1, 2018

Study Start

June 30, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)