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Network Meta-analysis of Intermittent Fasting and Cardiometabolic Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05309057
Recruitment Status : Active, not recruiting
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
Intermittent fasting is a method of restricting calories over a defined period of time and includes regimens such as whole-day fasting, alternate-day fasting, and time-restricted feeding. There is emerging evidence that intermittent fasting or energy restriction might be more beneficial than continuous energy restriction for some risk factors. The effect of intermittent fasting on risk factors associated with obesity, diabetes, and cardiovascular disease, however, is not clear. The European Association for the Study of Diabetes (EASD) has yet to make any recommendations regarding the role of intermittent fasting in the management of diabetes. To inform the update of the EASD Clinical Practice Guidelines for Nutrition Therapy, tthe Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned a systematic review and network meta-analysis of randomized controlled trials of the effect of different intermittent fasting strategies on established cardiometabolic risk factors. The findings generated by this proposed knowledge synthesis will shape guide current guidelines and improve health outcomes by educating healthcare providers and patients, and by guiding future research design.

Condition or disease Intervention/treatment
Obesity PreDiabetes Diabetes Hypertension NAFLD Metabolic Syndrome Dyslipidemias Inflammation Gout Cardiometabolic Syndrome Cardiovascular Diseases Dietary Supplement: Intermittent Fasting

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Intermittent Fasting Strategies on Cardiometabolic Risk: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Group/Cohort Intervention/treatment
Studies with intermittent fasting
Studies with intermittent fasting strategies.
Dietary Supplement: Intermittent Fasting
Methods of intermittent fasting strategies, continuous energy restriction, and ad libitum diet.




Primary Outcome Measures :
  1. Body weight [ Time Frame: Through study completion, up to 20 years ]
    Body weight in kg


Secondary Outcome Measures :
  1. Adiposity - BMI [ Time Frame: Through study completion, up to 20 years ]
    Body mass index (BMI) in kg/m2

  2. Adiposity - Waist circumference [ Time Frame: Through study completion, up to 20 years ]
    Waist circumference in cm

  3. Adiposity - Body fat [ Time Frame: Through study completion, up to 20 years ]
    Body fat in % (relative units)

  4. Glycemic control - HbA1c [ Time Frame: Through study completion, up to 20 years ]
    Glycemic control - HbA1c

  5. Glycemic control - fasting plasma glucose (FPG) [ Time Frame: Through study completion, up to 20 years ]
    Fasting plasma glucose (FPG) in mmol/L

  6. Glycemic control - 2h plasma glucose (2h-PG) [ Time Frame: Through study completion, up to 20 years ]
    2h plasma glucose (2h-PG) during a 75g oral glucose tolerance test (OGTT) in mmol/L

  7. Glycemic control - fasting plasma insulin (FPI) [ Time Frame: Through study completion, up to 20 years ]
    Fasting plasma insulin (FPI) in pmol/L

  8. Glycemic control - homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: Through study completion, up to 20 years ]
    Homeostasis model assessment of insulin resistance (HOMA-IR)

  9. Established blood lipid targets - LDL-cholesterol (LDL-C) [ Time Frame: Through study completion, up to 20 years ]
    LDL-cholesterol (LDL-C) in mmol/L

  10. Established blood lipid targets - non-HDL-cholesterol (non-HDL-C) [ Time Frame: Through study completion, up to 20 years ]
    non-HDL-cholesterol (non-HDL-C) in mmol/L

  11. Established blood lipid targets - apolipoprotein B (apo B) [ Time Frame: Through study completion, up to 20 years ]
    Apolipoprotein B (apo B) in g/L

  12. Established blood lipid targets - triglycerides [ Time Frame: Through study completion, up to 20 years ]
    Triglycerides in mmol/L

  13. Established blood lipid targets - HDL-cholesterol (HDL-C) [ Time Frame: Through study completion, up to 20 years ]
    HDL-cholesterol (HDL-C) in mmol/L

  14. Blood pressure - Systolic blood pressure (SBP) [ Time Frame: Through study completion ]
    Systolic blood pressure (SBP) in mmHg

  15. Blood pressure - diastolic blood pressure (DBP) [ Time Frame: Through study completion, up to 20 years ]
    Diastolic blood pressure (DBP) in mmHg

  16. Markers of non-alcoholic fatty liver disease (NAFLD) - Intrahepatocellular lipids (IHCL) [ Time Frame: Through study completion, up to 20 years ]
    Intrahepatocellular lipids (IHCL) in % (relative units)

  17. Markers of non-alcoholic fatty liver disease (NAFLD) - alanine transaminase (ALT) [ Time Frame: Through study completion, up to 20 years ]
    Alanine transaminase (ALT) in U/L

  18. Uric acid [ Time Frame: Through study completion, up to 20 years ]
    Uric acid in mmol/L

  19. Markers of inflammation - CRP [ Time Frame: Through study completion, up to 20 years ]
    CRP in mg/dL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults of all health statuses.
Criteria

Inclusion Criteria:

  • Randomized controlled trials in humans
  • Intermittent fasting intervention
  • Continuous energy restriction, ad libitum diet, or other intermittent fasting diet as comparators
  • Diet duration ≥1 weeks
  • Data for at least one prespecified outcome
  • Viable outcome data

Exclusion Criteria:

  • Non-human studies
  • Observational studies
  • Children
  • Multi-modal interventions
  • Diet duration < 1 weeks
  • No viable outcome data
  • Lack of suitable comparator

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): NCT05309057


Locations
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Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Faculty of Medicine
Toronto, Ontario, Canada
Sponsors and Collaborators
University of Toronto
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Responsible Party: John Sievenpiper, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT05309057    
Other Study ID Numbers: DNSG-IF
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
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
Keywords provided by John Sievenpiper, University of Toronto:
Intermittent fasting
Continuous energy restriction
Weight loss
Systematic review and meta-analysis
Network metanalysis
Randomized controlled trial
Clinical practice guideline
Adiposity
Glycemic control
Blood pressure
Blood lipids
NAFLD markers
Uric acid
inflammatory markers
Cardiometabolic risk factors
Additional relevant MeSH terms:
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Cardiovascular Diseases
Metabolic Syndrome
Dyslipidemias
Syndrome
Inflammation
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders