Short Term Intermittent Fasting and Mediterranean Diet

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02148458

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Pre-hypertension Hypertension Hypercholesterolemia Glucose Intolerance	Other: Mediterranean diet Other: Control group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Metabolic and Molecular Effects of a Mediterranean Diet and Intermittent Fasting

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Control group Western diet for 8 weeks, followed by 8 weeks of Western diet with intermittent fasting.	Other: Control group 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).
Experimental: Mediterranean diet Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting.	Other: Mediterranean diet 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)

Arm

Intervention/Treatment

Other: Control group

Western diet for 8 weeks, followed by 8 weeks of Western diet with intermittent fasting.

Other: Control group

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).

Experimental: Mediterranean diet

Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting.

Other: Mediterranean diet

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University school of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Valeria Tosti, MD, Washington University School of Medicine
Principal Investigator: Luigi Fontana, MD, PhD, Washington University School of Medicine