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Potential Effects of Intermittent Fasting to Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03608800
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Min Xia, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE July 22, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE June 30, 2018
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • gut microbiota composition [ Time Frame: 1 year ]
    gut microbiota composition determined by 16s rRNA pcr
  • plasma hs-CRP [ Time Frame: 1 year ]
    plasma proinflammatory hs-CRP(mg/L)
  • plasma LTB4 [ Time Frame: 1 year ]
    plasma proinflammatory LTB4(pg/mL)
  • plasma TXB2 [ Time Frame: 1 year ]
    plasma proinflammatory TXB2(ng/mL)
  • plasma PGE2 [ Time Frame: 1 year ]
    plasma proinflammatory PGE2(ng/mL)
  • serum LDL-cholesterol [ Time Frame: 1 year ]
    serum LDL-cholesterol(mmol/L);
  • serum HDL-cholesterol [ Time Frame: 1 year ]
    serum HDL-cholesterol(mmol/L);
  • brachial-ankle pulse wave velocity [ Time Frame: 1 year ]
    bilateral baPWV(cm/s)
  • ankle brachial pressure index [ Time Frame: 1 year ]
    the ratio of bilateral blood pressure at the ankle to the blood pressure in the upper arm (brachium)
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
gut microbiota composition [ Time Frame: 1 year ]
gut microbiota composition determined by 16s rRNA pcr
Change History Complete list of historical versions of study NCT03608800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • systolic pressure [ Time Frame: 1 year ]
    systolic pressure(mmHg)
  • diastolic pressure [ Time Frame: 1 year ]
    diastolic pressure(mmHg)
  • BMI [ Time Frame: 1 year ]
    BMI(weight in kilograms, height in meters and BMI in kg/m^2)
  • faecal p-cresol [ Time Frame: 1year ]
    amino acid metabolites including p-cresol(μg/mg)
  • faecal indole [ Time Frame: 1year ]
    amino acid metabolites including indole(μg/mg)
  • faecal 3-indolepropionic acid [ Time Frame: 1year ]
    amino acid metabolites including 3-indolepropionic acid(μg/mg)
  • faecal butyric acid [ Time Frame: 1year ]
    lipid metabolites including butyric acid(μg/mg)
  • body fat ratio [ Time Frame: 1 year ]
    the total mass of fat divided by total body mass
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • serum LDL-cholesterol [ Time Frame: 1year ]
    serum LDL-cholesterol(mmol/L);
  • serum HDL-cholesterol [ Time Frame: 1year ]
    serum HDL-cholesterol(mmol/L);
  • systolic pressure [ Time Frame: 1 year ]
    systolic pressure(mmHg)
  • diastolic pressure [ Time Frame: 1 year ]
    diastolic pressure(mmHg)
  • BMI [ Time Frame: 1 year ]
    BMI(weight in kilograms, height in meters and BMI in kg/m^2)
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2019)
biochemical pathways [ Time Frame: 1 year ]
steroid hormone biosynthesis, arachidonic acid metabolism and lipopolysaccharide biosynthesis
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Potential Effects of Intermittent Fasting to Metabolic Syndrome
Official Title  ICMJE Potential Effects of Intermittent Fasting to Gut Microbiota of Metabolic Syndrome Subjects
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE Behavioral: Intermittent fasting
The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks
Study Arms  ICMJE
  • Experimental: Intermittent fasting
    two nonconsecutive days of 75% diet energy restriction per week for 8 weeks
    Intervention: Behavioral: Intermittent fasting
  • No Intervention: Control diet
    maintain the energy intake as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Either three or more risk factors among following tips:

    1. Hypertension( systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg or under medication of hypotension)
    2. Serum TG≥1.7mmol/L and(or) HDL-c<1.0mmol/L(female), HDL-c<0.9mmol/L(male);
    3. Fasting plasma glucose≥6.1mmol/L and(or) 2-hour postprandial plasma glucose≥7.8mmol/L;
    4. BMI≥25.0kg/m2;

Exclusion Criteria:

  • Complications including diabetes, cardiovascular diseases (angina, myocardial infarction), thyroid diseases and so on.
  • Taken antibiotic drugs in the past 3 months
  • Suffered from infectious diseases(pharyngitis, diarrhea, dermatitis) in last month
  • Alcohol abuse (alcohol intake>60g/d for male and alcohol intake>40g/d for female)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Min Xia, Doctor +86(20)-87332433 xiamin@mail.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03608800
Other Study ID Numbers  ICMJE 2018IF01-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Min Xia, Sun Yat-sen University
Study Sponsor  ICMJE Min Xia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Min Xia, Doctor Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP