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

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Other: Intermittent Fasting group; Other: control group

• Registration Number: NCT01964118
• Lead Sponsor: Washington University School of Medicine

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intermittent Fasting group	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).
Control group	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.

Primary Outcome Measures

Name	Time	Method
Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months	Every 6 months- baseline, 6 month and 12 month	HSCRP would be measured in mg/L

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States