NCT02148458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

May 22, 2014

Last Update Submit

May 21, 2021

Conditions

OverweightPre-hypertensionHypertensionHypercholesterolemiaGlucose Intolerance

Keywords

Intermittent fastingMediterranean dietoverweightCalorie restriction

Outcome Measures

Primary Outcomes (1)

  • Decrease in high sensitivity C-reactive protein (hsCRP)

    hsCRP is in mg/L

    16 weeks-- Baseline, 8 weeks, 16 weeks

Study Arms (2)

Control group

OTHER

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

Other: Control group

Mediterranean diet

EXPERIMENTAL

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

Other: Mediterranean diet

Interventions

Mediterranean dietOTHER

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)

Mediterranean diet
Control groupOTHER

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).

Control group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.
  • Currently eating diet similar to Mediterranean diet based on dietary and food frequency questionnaires and 4-day food diary.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University school of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

    PMID: 33512717DERIVED

MeSH Terms

Conditions

OverweightPrehypertensionHypertensionHypercholesterolemiaGlucose IntoleranceIntermittent Fasting

Interventions

Diet, MediterraneanControl Groups

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesHyperglycemiaGlucose Metabolism DisordersFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Valeria Tosti, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Luigi Fontana, MD, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

May 28, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Plan to publish

Locations

US(1)