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Short Term Intermittent Fasting and Mediterranean Diet

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ClinicalTrials.gov Identifier: NCT02148458
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Overweight Pre-hypertension Hypertension Hypercholesterolemia Glucose Intolerance Other: Mediterranean diet Other: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Decrease in high sensitivity C-reactive protein (hsCRP) [ Time Frame: 16 weeks-- Baseline, 8 weeks, 16 weeks ]
    hsCRP is in mg/L



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148458


Locations
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United States, Missouri
Washington University school of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Valeria Tosti, MD Washington University School of Medicine
Principal Investigator: Luigi Fontana, MD, PhD Washington University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02148458    
Other Study ID Numbers: 201404045
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan to publish
Keywords provided by Washington University School of Medicine:
Intermittent fasting
Mediterranean diet
overweight
Calorie restriction
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Hypercholesterolemia
Glucose Intolerance
Overweight
Vascular Diseases
Cardiovascular Diseases
Body Weight
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Glucose Metabolism Disorders