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

Study Overview
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Brief Summary
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The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.

Detailed Description
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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

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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Other: Intermittent Fasting group
* Other: control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>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. | Other: control group<br>* usual diet for 6 months and intermittent fasting for other 6 months<br>|
| Experimental: Intermittent Fasting group<br>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). | Other: Intermittent Fasting group<br>* Intermittent fasting for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months | HSCRP would be measured in mg/L | Every 6 months- baseline, 6 month and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, intermittent fasting, calorie restriction