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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

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Intermittent fasting Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Potential Effects of Intermittent Fasting to Gut Microbiota of Metabolic Syndrome Subjects
Actual Study Start Date : June 30, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intermittent fasting
two nonconsecutive days of 75% diet energy restriction per week for 8 weeks
Behavioral: Intermittent fasting
The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks

No Intervention: Control diet
maintain the energy intake as usual



Primary Outcome Measures :
  1. gut microbiota composition [ Time Frame: 1 year ]
    gut microbiota composition determined by 16s rRNA pcr

  2. plasma hs-CRP [ Time Frame: 1 year ]
    plasma proinflammatory hs-CRP(mg/L)

  3. plasma LTB4 [ Time Frame: 1 year ]
    plasma proinflammatory LTB4(pg/mL)

  4. plasma TXB2 [ Time Frame: 1 year ]
    plasma proinflammatory TXB2(ng/mL)

  5. plasma PGE2 [ Time Frame: 1 year ]
    plasma proinflammatory PGE2(ng/mL)

  6. serum LDL-cholesterol [ Time Frame: 1 year ]
    serum LDL-cholesterol(mmol/L);

  7. serum HDL-cholesterol [ Time Frame: 1 year ]
    serum HDL-cholesterol(mmol/L);

  8. brachial-ankle pulse wave velocity [ Time Frame: 1 year ]
    bilateral baPWV(cm/s)

  9. 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)


Secondary Outcome Measures :
  1. systolic pressure [ Time Frame: 1 year ]
    systolic pressure(mmHg)

  2. diastolic pressure [ Time Frame: 1 year ]
    diastolic pressure(mmHg)

  3. BMI [ Time Frame: 1 year ]
    BMI(weight in kilograms, height in meters and BMI in kg/m^2)

  4. faecal p-cresol [ Time Frame: 1year ]
    amino acid metabolites including p-cresol(μg/mg)

  5. faecal indole [ Time Frame: 1year ]
    amino acid metabolites including indole(μg/mg)

  6. faecal 3-indolepropionic acid [ Time Frame: 1year ]
    amino acid metabolites including 3-indolepropionic acid(μg/mg)

  7. faecal butyric acid [ Time Frame: 1year ]
    lipid metabolites including butyric acid(μg/mg)

  8. body fat ratio [ Time Frame: 1 year ]
    the total mass of fat divided by total body mass


Other Outcome Measures:
  1. biochemical pathways [ Time Frame: 1 year ]
    steroid hormone biosynthesis, arachidonic acid metabolism and lipopolysaccharide biosynthesis



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608800


Contacts
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Contact: Min Xia, Doctor +86(20)-87332433 xiamin@mail.sysu.edu.cn

Locations
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China, Guangdong
Department of Nutrition and Food Hygiene Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Min Xia, Doctor         
Sponsors and Collaborators
Min Xia
Investigators
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Principal Investigator: Min Xia, Doctor Sun Yat-sen University

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Responsible Party: Min Xia, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03608800     History of Changes
Other Study ID Numbers: 2018IF01-1
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases