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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02148458
Other study ID # 201404045
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date June 2017

Study information

Verified date May 2021
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 65 Years
Eligibility 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. 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.

Study Design


Intervention

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)
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).

Locations

Country Name City State
United States Washington University school of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease in high sensitivity C-reactive protein (hsCRP) hsCRP is in mg/L 16 weeks-- Baseline, 8 weeks, 16 weeks
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