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History of Changes for Study: NCT02148458
Short Term Intermittent Fasting and Mediterranean Diet
Latest version (submitted May 21, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 22, 2014 None (earliest Version on record)
2 December 9, 2014 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations and Conditions
3 June 1, 2015 Study Status, Eligibility and Study Design
4 December 9, 2015 Study Status
5 April 7, 2016 Study Status, IPDSharing and Contacts/Locations
6 October 10, 2016 Study Status
7 May 8, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 October 5, 2018 Recruitment Status and Study Status
9 March 24, 2021 Study Status and Contacts/Locations
10 May 21, 2021 Study Status and Contacts/Locations
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Study NCT02148458
Submitted Date:  May 22, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 201404045
Brief Title: Short Term Intermittent Fasting and Mediterranean Diet
Official Title: Metabolic and Molecular Effects of a Mediterranean Diet and Intermittent Fasting
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2014
Overall Status: Not yet recruiting
Study Start: June 2014
Primary Completion: December 2016 [Anticipated]
Study Completion: December 2016 [Anticipated]
First Submitted: May 22, 2014
First Submitted that
Met QC Criteria:
May 22, 2014
First Posted: May 28, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 22, 2014
Last Update Posted: May 28, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Washington University School of Medicine
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Overweight
Pre-hypertension
Hypertension
Hypercholesterolemia
Glucose Intolerance
High Risk Waist Circumference
Keywords: Intermittent fasting
Mediterranean diet
overweight
Calorie restriction
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Control group and intermittent fasting
Usual western diet for 8 weeks, followed by 8 weeks of usual diet with intermittent fasting.
Control group and intermittent fasting
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 and intermittent fasting
Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting.
Mediterranean diet and intermittent fasting
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)
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. - The participants in this study will be 40 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.

Open or close this module Contacts/Locations
Central Contact Person: Shohreh Jamalabadi-Majidi, DMD, MPH
Telephone: 314-362-2399
Email: sjamalab@dom.wustl.edu
Study Officials: Luigi Fontana, MD, PhD
Principal Investigator
Washington University School of Medicine
Locations: United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Contact:Contact: Shohreh Jamalabadi-Majidi, DMD, MPH 314-362-2399 sjamalab@dom.wustl.edu
Contact:Principal Investigator: Luigi Fontana, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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