Short Term Intermittent Fasting and Mediterranean Diet

Not Applicable

Completed

• Conditions: Glucose Intolerance; Pre-hypertension; Hypertension; Hypercholesterolemia; Overweight
• Interventions: Other: Control group; Other: Mediterranean diet

• Registration Number: NCT02148458
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-28
• Study Start: 2014-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. • 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),
2. • Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).
3. • 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Western diet for 8 weeks, followed by 8 weeks of Western diet with intermittent fasting.
Mediterranean diet	Mediterranean diet	Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting.

Primary Outcome Measures

Name	Time	Method
Decrease in high sensitivity C-reactive protein (hsCRP)	16 weeks-- Baseline, 8 weeks, 16 weeks	hsCRP is in mg/L

Trial Locations

Locations (1)

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