Normal and Overweight Individuals at High-risk of DiabetesNCT05722873
The Metabolic Effects of Intermittent Fasting
A study testing Fasting arm, Weight maintenance and Counseling in people with Normal and Overweight Individuals at High-risk of Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal and Overweight Individuals at High-risk of Diabetes
- What is being tested?
- Fasting arm, Weight maintenance and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, ages 21-45 years
- BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
- Normal thyroid function
- Regular menses (women)
- At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes
Who cannot join
- Any chronic diseases including hypertension and Type 2 diabetes mellitus
- Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL>190 or an estimated 10-year ASCVD risk of >7.5%)
- Chronic medications, including oral contraceptive pills
- Pregnant and/or breastfeeding
- History of an eating disorder
- 25-OH vitamin D level < 20 ng/mL
Show all 9Show fewer
- Active substance abuse, including alcohol
- Subjects with a prior history of intermittent fasting
- The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Pouneh Fazeli, MD, pkfazeli@pitt.edu
About this study
Official title: The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.
- Being tested
- Fasting arm, Weight maintenance, Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting armBehavioural
Study participants will fast one day per week for 12 weeks
Weight maintenanceBehavioural
Study participants will be counseled to maintain body weight
CounselingBehavioural
Study participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | Subjects will fast one-day per week for 12 weeks Receives: Behavioral: Fasting arm |
| Fasting with weight maintenance | Experimental | Subjects will fast one-day per week for 12 weeks and maintain body weight Receives: Behavioral: Fasting arm; Behavioral: Weight maintenance |
| Counseling | Placebo comparator | Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care) Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride carbon content and degree of saturation
Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits
Measured: Baseline, 3 months
Trabecular bone microarchitecture
Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits
Measured: Baseline, 3 months
Secondary outcomes (1)
Insulin sensitivity
Change in insulin sensitivity as assessed by hyperinsulinemic-euglycemic clamp between Baseline and Final Intervention visits
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start25 Oct 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal and Overweight Individuals at High-risk of DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouneh K. Fazeli, MD, University of Pittsburgh
- Investigators
- Pouneh Fazeli, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722873
- Sponsor's protocol ID
- STUDY21120112
- Other IDs
- R01DK133578
- Status last verified
- May 2026
- First submitted
- 27 Jan 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified information will be shared upon request.
Publications
Quaytman JA, David NL, Venugopal S, Amorim T, Beatrice B, Toledo FGS, Miller RG, Steinhauser ML, Fazeli PK. Intermittent fasting for systemic triglyceride metabolic reprogramming (IFAST): Design and methods of a prospective, randomized, controlled trial. Contemp Clin Trials. 2024 Nov;146:107698. doi: 10.1016/j.cct.2024.107698. Epub 2024 Sep 17.
PubMed 39299543
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
- ClinicalTrials.gov ID
- NCT05722873
- Acronym / sponsor ID
- STUDY21120112
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Feb 2023 (actual)
- 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.
Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Behavioral: Fasting armSubjects will fast one-day per week for 12 weeks |
| Fasting with weight maintenance | Experimental | Behavioral: Fasting arm, Behavioral: Weight maintenanceSubjects will fast one-day per week for 12 weeks and maintain body weight |
| Counseling | Placebo comparator | Behavioral: CounselingSubjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women, ages 21-45 years
- BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
- Normal thyroid function
- Regular menses (women)
- At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes
Key exclusion criteria (9 listed)
- Any chronic diseases including hypertension and Type 2 diabetes mellitus
- Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL>190 or an estimated 10-year ASCVD risk of >7.5%)
- Chronic medications, including oral contraceptive pills
- Pregnant and/or breastfeeding
- History of an eating disorder
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 |
|---|---|---|
| Fasting armStudy participants will fast one day per week for 12 weeks | Behavioural | Fasting, Fasting with weight maintenance |
| Weight maintenanceStudy participants will be counseled to maintain body weight | Behavioural | Fasting with weight maintenance |
| CounselingStudy participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI | Behavioural | Counseling |
Primary outcome
Triglyceride carbon content and degree of saturation
Time frame: Baseline, 3 months
Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits
Trabecular bone microarchitecture
Time frame: Baseline, 3 months
Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits
1 secondary outcome
Insulin sensitivity
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 39299543Quaytman JA, David NL, Venugopal S, Amorim T, Beatrice B, Toledo FGS, Miller RG, Steinhauser ML, Fazeli PK. Intermittent fasting for systemic triglyceride metabolic reprogramming (IFAST): Design and methods of a prospective, randomized, controlled trial. Contemp Clin Trials. 2024 Nov;146:107698. doi: 10.1016/j.cct.2024.107698. Epub 2024 Sep 17.
- Individual participant dataSharing planned: Yes. Deidentified information will be shared upon request.
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.
Pouneh Fazeli, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting arm, Weight maintenance and Counseling in people with Normal and Overweight Individuals at High-risk of Diabetes, run by University of Pittsburgh 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pouneh Fazeli, MD (412-648-9770, pkfazeli@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglyceride carbon content and degree of saturation (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. 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 NCT05722873, which also lists 1 linked publication.
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 18 May 2026.