Short Term Intermittent Fasting and Mediterranean Diet

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the effects of intermittent fasting in subjects that are eating a Mediterranean diet or a Western diet. This study is part of ongoing research in the prevention and treatment of age-related diseases at Washington University School of Medicine.

Detailed Description
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The primary objective of this study is to determine whether or not IF, independently of changes in quality of diet, reduces the level of chronic inflammation as evidenced by a decrease in high sensitivity C-reactive protein (hsCRP), as the main outcome measure.

Official Title
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Metabolic and Molecular Effects of a Mediterranean Diet and Intermittent Fasting

Conditions
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Overweight, Pre-hypertension, Hypertension, Hypercholesterolemia, Glucose Intolerance

Intervention / Treatment
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* Other: Mediterranean diet
* 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 overweight range (i.e. 22 to 28 kg/m2), - Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained). - Participants have at least one of these metabolic abnormalities: pre-hypertension or hypertension (i.e. systolic blood pressure > 120 mmHg or diastolic blood pressure > 80 mmHg or specific treatment of previously diagnosed hypertension)10, sub-optimal lipid levels (i.e. LDL-cholesterol > 100 mg/dl or HDL-cholesterol < 59 mg/dl or specific treatment for this lipid abnormality)11, impaired fasting glucose or glucose intolerance (i.e. fasting glucose > 100 mg/dl or 2 hr-glucose during OGTT with a glucose load of 75 g > 140 mg/dl or specific treatment for previously diagnosed type 2 diabetes)12, or high-risk waist circumference (≥ 94 cm in men and ≥ 80 cm in women)13. Exclusion Criteria: - 1 - History of any chronic disease process that could interfere with interpretation of results 2 - Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance. 3 - Currently eating diet similar to Mediterranean diet based on dietary and food frequency questionnaires and 4-day food diary.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Western diet for 8 weeks, followed by 8 weeks of Western diet with intermittent fasting. | Other: Control group<br>* control group eating their usual Western diet for 8 weeks, followed by 8 weeks of usual diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week).<br>|
| Experimental: Mediterranean diet<br>Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting. | Other: Mediterranean diet<br>* Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in high sensitivity C-reactive protein (hsCRP) | hsCRP is in mg/L | 16 weeks-- Baseline, 8 weeks, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent fasting, Mediterranean diet, overweight, Calorie restriction