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Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction? (IF)

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: NCT01964118
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE October 7, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date May 24, 2021
Actual Study Start Date  ICMJE July 2013
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months [ Time Frame: Every 6 months- baseline, 6 month and 12 month ]
HSCRP would be measured in mg/L
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
Official Title  ICMJE Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
Brief Summary The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.
Detailed Description The primary objective of this study is to determine whether or not IF reduces the level of chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP), as the main outcome measure
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Other: Intermittent Fasting group
    Intermittent fasting for 12 months
  • Other: control group
    usual diet for 6 months and intermittent fasting for other 6 months
Study Arms  ICMJE
  • Control group
    The participants randomized to the crossover group begin study participation as a control group (no changes in food intake) for the first 6 months and switch to IF for the remaining 6 months of the study.
    Intervention: Other: control group
  • Experimental: Intermittent Fasting group
    Participant with a BMI between 28 and 35 kg/m2 will fast 3 non-consecutive days per week, whereas participant with a BMI between 24 and 27.9 kg/m2 will fast 2 non-consecutive days per week. Individuals following intermittent fasting (IF) will work with the study dietitian to design their weekly meal plans and menus for the non-fasting days. The subjects following IF will be asked to skip breakfast, lunch, dinner, snacks, and calorie-containing beverages on the fast days, but we will give them the option to consume at dinner a big salad (i.e. non-starchy raw and/or cooked vegetables dressed with 2 tablespoons of salad dressing prepared with vegetable oil, vinegar and seasonings).
    Intervention: Other: Intermittent Fasting group
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2013)
40
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high normal to moderately obese range (i.e. 24 to 35 kg/m2),
  • Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).

Exclusion Criteria:

  • History of any chronic disease process that could interfere with interpretation of results
  • Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01964118
Other Study ID Numbers  ICMJE 201303081
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only to publish
Current Responsible Party Washington University School of Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Washington University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valeria Tosti, MD Washington University School of Medicine
Principal Investigator: Luigi Fontana, MD, Phd Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date May 2021

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