ObesityIFNCT01964118
Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
A study testing Intermittent Fasting group in people with Obesity and Overweight, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Intermittent Fasting group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.
Read the detailed description
The primary objective of this study is to determine whether or not IF reduces the level of chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP), as the main outcome measure
- Conditions
- Obesity, Overweight
- Being tested
- Intermittent Fasting group, control group
- Keywords
- intermittent fasting, obesity, calorie restriction
- Medical subject headings
- Obesity, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Fasting groupOther
Intermittent fasting for 12 months
control groupOther
usual diet for 6 months and intermittent fasting for other 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Intermittent Fasting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months
HSCRP would be measured in mg/L
Measured: Every 6 months- baseline, 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valeria Tosti, MD, Principal investigator, Washington University School of MedicineLuigi Fontana, MD, Phd, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964118
- Sponsor's protocol ID
- 201303081
- Acronym
- IF
- Status last verified
- May 2021
- First submitted
- 7 Oct 2013
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only to publish
Publications
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.
PubMed 7117847Barve 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.
PubMed 41390492Allaf 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.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
- ClinicalTrials.gov ID
- NCT01964118
- Acronym / sponsor ID
- IF / 201303081
- Conditions
- Obesity, Overweight
- Keywords
- intermittent fasting, obesity, calorie restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.
Detailed description
The primary objective of this study is to determine whether or not IF reduces the level of chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP), as the main outcome measure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: control groupThe 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. |
| Intermittent Fasting group | Experimental | Other: Intermittent Fasting groupParticipant 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). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Fasting groupIntermittent fasting for 12 months | Other | Intermittent Fasting group |
| control groupusual diet for 6 months and intermittent fasting for other 6 months | Other | Control group |
Primary outcome
Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months
Time frame: Every 6 months- baseline, 6 month and 12 month
HSCRP would be measured in mg/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Background: PubMed 7117847Goodrick 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.
- Derived from this study: PubMed 41390492Barve 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.
- Derived from this study: PubMed 33512717Allaf 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.
- Individual participant dataSharing planned: No. Only to publish
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Tosti, MD principal investigator
Washington University School of Medicine
Luigi Fontana, MD, Phd principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting group in people with Obesity and Overweight, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (time frame: Every 6 months- baseline, 6 month and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01964118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.