NCT01964118

Brief Summary

The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable obesity

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

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

October 7, 2013

Last Update Submit

May 21, 2021

Conditions

ObesityOverweight

Keywords

intermittent fastingobesitycalorie restriction

Outcome Measures

Primary Outcomes (1)

  • Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months

    HSCRP would be measured in mg/L

    Every 6 months- baseline, 6 month and 12 month

Study Arms (2)

Control group

OTHER

The participants randomized to the crossover group begin study participation as a control group (no changes in food intake) for the first 6 months and switch to IF for the remaining 6 months of the study.

Other: control group

Intermittent Fasting group

EXPERIMENTAL

Participant with a BMI between 28 and 35 kg/m2 will fast 3 non-consecutive days per week, whereas participant with a BMI between 24 and 27.9 kg/m2 will fast 2 non-consecutive days per week. Individuals following intermittent fasting (IF) will work with the study dietitian to design their weekly meal plans and menus for the non-fasting days. The subjects following IF will be asked to skip breakfast, lunch, dinner, snacks, and calorie-containing beverages on the fast days, but we will give them the option to consume at dinner a big salad (i.e. non-starchy raw and/or cooked vegetables dressed with 2 tablespoons of salad dressing prepared with vegetable oil, vinegar and seasonings).

Other: Intermittent Fasting group

Interventions

Intermittent Fasting groupOTHER

Intermittent fasting for 12 months

Intermittent Fasting group
control groupOTHER

usual diet for 6 months and intermittent fasting for other 6 months

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 obese range (i.e. 24 to 35 kg/m2),
  • Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).

You may not qualify if:

  • History of any chronic disease process that could interfere with interpretation of results
  • Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.

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 (3)

  • Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider NL. Effects of intermittent feeding upon growth and life span in rats. Gerontology. 1982;28(4):233-41. doi: 10.1159/000212538.

    PMID: 7117847BACKGROUND

  • Barve RA, Veronese N, Bertozzi B, Tosti V, Cagigas ML, Spelta F, Cava E, Piccio L, Early DS, Head RD, Fontana L. Cardiometabolic and molecular adaptations to 6-month intermittent fasting in middle-aged men and women with overweight: secondary outcomes of a randomized controlled trial. Nat Commun. 2025 Dec 13;16(1):11370. doi: 10.1038/s41467-025-66366-8.

    PMID: 41390492DERIVED

  • 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

ObesityOverweightIntermittent Fasting

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic 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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 17, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Only to publish

Locations

US(1)